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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| University of Michigan | OTHER |
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The investigators will conduct a 13,000-patient randomized multi-center trial to determine (i) which general anesthesia technique yields superior patient recovery experiences in any of three surgical categories ((a) major inpatient surgery, (b) minor inpatient surgery, (c) outpatient surgery) and (ii) whether TIVA confers no more than a small (0.2 %) increased risk of intraoperative awareness than INVA in patients undergoing both outpatient and inpatient surgeries
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol total intravenous anesthesia (TIVA) | Active Comparator | No administration of inhaled agent. |
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| inhaled volatile general anesthesia (INVA) | Active Comparator | Must administer inhaled agent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anesthetic technique Propofol TIVA | Other | Propofol TIVA no inhaled agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after major inpatient surgery | The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery. | Postoperative day 1 |
| Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after minor inpatient surgery | The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery. | Postoperative day 1 |
| Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after outpatient surgery | The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery. | Postoperative day 1 |
| Incidence of definite intraoperative awareness with recall | The modified Brice questionnaire is used to screen for intraoperative awareness. A positive screen (a patient who reports remembering anything between going to sleep for their surgical procedure and waking up after) on the modified Brice questionnaire is followed by a structured interview. A panel of expert adjudicators determines whether or not this was definite intraoperative awareness. | Postoperative day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after major inpatient surgery | The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery. | postoperative day 0 |
| Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after minor inpatient surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Daily step count as measured by wearable device at baseline for those scheduled for major inpatient surgery. | Daily step count at baseline - number of steps per day | 1 - 7 days prior to surgery |
| Daily step count as measured by wearable device at baseline for those scheduled for minor inpatient surgery. |
Inclusion Criteria
Each patient must meet all of the following criteria:
Exclusion Criteria
Patients will not be enrolled if any of the following criteria are met:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Swisher | Contact | 314-286-1024 | goodl@wustl.edu | |
| Sherry McKinnon | Contact | 314-286-1024 | smckinnon@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sachin Kheterpal, MD | University of Michigan | Principal Investigator |
| Michael S Avidan, MBBCh | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences (UAMS) | Recruiting | Little Rock | Arkansas | 72205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40953862 | Derived | Tellor Pennington BR, Janda AM, Colquhoun DA, Neuman MD, Kidwell KM, Spino C, Thelen-Perry S, Krambrink A, Huang S, Ignacio R, Wu Z, Swisher L, Cloyd C, Vaughn MT, Pescatore NA, Bollini ML, Mashour GA, Hassett A, Kent CD, Vlisides PE, Avidan MS, Kheterpal S; Ë THRIVE Research Group. Trajectories of Recovery after Intravenous propofol versus inhaled VolatilE anaesthesia (THRIVE) randomised controlled trial in the USA: A protocol. BMJ Open. 2025 Sep 14;15(9):e103836. doi: 10.1136/bmjopen-2025-103836. |
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Per the contract with the funder PCORI, the THRIVE Data Sharing Plan will be consistent with PCORI's Policy for Data Management and Data Sharing, which calls for the researchers PCORI funds to share their data sets and documentation for reanalysis and reuse. THRIVE will upload a deidentified dataset to the Patient-Centered Outcomes Data Repository (PCODR), which was created and is hosted by the Inter-University Consortium for Political and Social Research (ICPSR), a unit within the Institute for Social Research at the University of Michigan. The THRIVE study, as the Awardee, will enter into a Data Contributor Agreement (DCA) with ICPSR. The DCA governs the data deposition and establishes the Awardee's rights and obligations. The data package will be transferred to the data repository by October 1, 2028, per the contract with PCORI.
The data package will be transferred to the data repository by October 1, 2028, per the contract with PCORI.
PCORI's access criteria and data sharing policy for third parties can be found here https://www.pcori.org/sites/default/files/PCORI-Policy-for-Data-Management-and-Data-Sharing.pdf
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| Anesthetic technique inhaled agent | Other | Must administer inhaled agent. |
|
|
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery. |
| postoperative day 0 |
| Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after outpatient surgery | The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery. | postoperative day 0 |
| Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after major inpatient surgery | The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery. | postoperative day 2 |
| Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after minor inpatient surgery | The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery. | postoperative day 2 |
| Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after outpatient surgery | The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery. | postoperative day 2 |
| Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after major inpatient surgery | The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery. | postoperative day 7 |
| Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after minor inpatient surgery | The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery. | postoperative day 7 |
| Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after outpatient surgery | The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery. | postoperative day 7 |
| Days Alive and at Home at 30 days after major inpatient surgery | Patient hospital length of stay after the surgery is documented. A patient completed survey assesses hospital re-admission since discharge from surgery and days spent in the hospital since original discharge. | postoperative day 30 |
| Days Alive and at Home at 30 days after minor inpatient surgery | Patient hospital length of stay after the surgery is documented. A patient completed survey assesses hospital re-admission since discharge from surgery and days spent in the hospital since original discharge. | postoperative day 30 |
| Days Alive and at Home at 30 days after outpatient surgery | Patient hospital length of stay after the surgery is documented. A patient completed survey assesses hospital re-admission since discharge from surgery and days spent in the hospital since original discharge. | postoperative day 30 |
| Incidence of delirium on postoperative day 0 after major inpatient surgery | The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. | postoperative day 0 |
| Incidence of delirium on postoperative day 0 after minor inpatient surgery | The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. | postoperative day 0 |
| Incidence of delirium on postoperative day 0 after outpatient surgery | The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. | postoperative day 0 |
| Incidence of delirium on postoperative day 1 after major inpatient surgery | The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. | postoperative day 1 |
| Incidence of delirium on postoperative day 1 after minor inpatient surgery | The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. | postoperative day 1 |
| Delirium Severity Score on postoperative day 0 after major inpatient surgery | The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The 3D-CAM severity score is calculated by adding 1 point for each positive item noted in questions 1-20. The score is calculated out of 20 points - a higher score indicates a higher severity. | postoperative day 0 |
| Delirium Severity Score on postoperative day 0 after minor inpatient surgery | The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The 3D-CAM severity score is calculated by adding 1 point for each positive item noted in questions 1-20. The score is calculated out of 20 points - a higher score indicates a higher severity. | postoperative day 0 |
| Delirium Severity Score on postoperative day 0 after outpatient surgery | The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The 3D-CAM severity score is calculated by adding 1 point for each positive item noted in questions 1-20. The score is calculated out of 20 points - a higher score indicates a higher severity. | postoperative day 0 |
| Delirium Severity Score on postoperative day 1 after major inpatient surgery | The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The 3D-CAM severity score is calculated by adding 1 point for each positive item noted in questions 1-20. The score is calculated out of 20 points - a higher score indicates a higher severity. | postoperative day 1 |
| Delirium Severity Score on postoperative day 1 after minor inpatient surgery | The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The 3D-CAM severity score is calculated by adding 1 point for each positive item noted in questions 1-20. The score is calculated out of 20 points - a higher score indicates a higher severity. | postoperative day 1 |
| Incidence of Subsyndromal delirium on postoperative day 0 after major inpatient surgery | The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium. | postoperative day 0 |
| Incidence of Subsyndromal delirium on postoperative day 0 after minor inpatient surgery | The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium. | postoperative day 0 |
| Incidence of Subsyndromal delirium on postoperative day 0 after outpatient surgery | The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium. | postoperative day 0 |
| Incidence of Subsyndromal delirium on postoperative day 1 after major inpatient surgery | The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium. | postoperative day 1 |
| Incidence of Subsyndromal delirium on postoperative day 1 after minor inpatient surgery | The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium. | postoperative day 1 |
| Health-related quality-of-life on postoperative day 30 after major inpatient surgery | EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf | postoperative day 30 |
| Health-related quality-of-life on postoperative day 30 after minor inpatient surgery | EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf | postoperative day 30 |
| Health-related quality-of-life on postoperative day 30 after outpatient surgery | EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf | postoperative day 30 |
| Health-related quality-of-life on postoperative day 90 after major inpatient surgery | EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf | postoperative day 90 |
| Health-related quality-of-life on postoperative day 90 after minor inpatient surgery | EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf | postoperative 90 days |
| Health-related quality-of-life on postoperative day 90 after outpatient surgery | EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf | postoperative day 90 |
| Health-related quality-of-life on postoperative day 180 after major inpatient surgery | EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf | postoperative day 180 |
| Health-related quality-of-life on postoperative day 180 after minor inpatient surgery | EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf | postoperative day 180 |
| Health-related quality-of-life on postoperative day 180 after outpatient surgery | EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf | postoperative day 180 |
| Health-related quality-of-life on postoperative day 365 after major inpatient surgery | EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf | postoperative day 365 |
| Health-related quality-of-life on postoperative day 365 after minor inpatient surgery | EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf | postoperative day 365 |
| Health-related quality-of-life on postoperative day 365 after outpatient surgery | EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf | postoperative day 365 |
| Functional status on postoperative day 30 after major inpatient surgery. | The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation. | postoperative day 30 |
| Functional status on postoperative day 30, after minor inpatient surgery. | The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation. | postoperative day 30 |
| Functional status on postoperative day 30, after outpatient surgery. | The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation. | postoperative day 30 |
| Functional status on postoperative day 90 after major inpatient surgery. | The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation. | postoperative day 90 |
| Functional status on postoperative day 90 after minor inpatient surgery. | The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation. | postoperative day 90 |
| Functional status on postoperative day 90 after outpatient surgery. | The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation. | postoperative day 90 |
| Patient satisfaction with anesthesia on postoperative day 2 | The Bauer questionnaire is a patient self-reported survey assessing anesthesia-related discomfort and satisfaction with anesthesia care. | postoperative day 2 |
| Respiratory Failure on postoperative day 0 | Respiratory failure defined as unplanned postoperative intubation or reintubation or continued mechanical ventilation > 6 hours postoperatively. Reintubation due to reoperation is excluded. | postoperative day 0 |
| Kidney Injury on postoperative day 7 | Kidney Injury defined as a serum creatinine increase of 50% or 0.3 mg/dl from preoperative baseline | postoperative day 7 |
| All-Cause Mortality at POD30 | All-Cause Mortality at POD30 | postoperative day 30 |
| All-Cause Mortality at POD90 | All-Cause Mortality at POD90 | postoperative day 90 |
| Intraoperative Hypotension (1) | Intraoperative Hypotension defined as cumulative duration of mean arterial pressure <55 mmHg for 20 minutes or greater. | postoperative day 0 |
| Intraoperative Hypotension (2) | Intraoperative hypotension defined as cumulative duration of mean arterial pressure < 65 mmHg for 20 minutes or greater. | postoperative day 0 |
| Moderate or Severe Intraoperative Patient Movement | Moderate or Severe Intraoperative Patient Movement is based on clinician report. | postoperative day 0 |
| Unplanned Admission After Outpatient Surgery in an Ambulatory Setting | Hospital admission no later than 24 hours postoperatively after outpatient surgery in a free-standing ambulatory surgery center setting | postoperative days 0 and 1 |
| Incidence of propofol-related infusion syndrome | Propofol related infusion syndrome, defined as acute refractory bradycardia in the presence of metabolic acidosis, and at least one of the following: rhabdomyolysis, acute kidney injury or hypertriglyceridemia, occurring after the start of propofol intraoperatively and within 6 hours postoperatively. | postoperative day 0 |
| Incidence of malignant hyperthermia | Malignant hyperthermia, defined as unexplained muscle rigidity, tachycardia, hypercapnia, and rapidly increasing temperature leading to metabolic acidosis, rhabdomyolysis, disseminated intravascular coagulation, and ventricular arrhythmias, occurring after the start of an inhaled volatile agent intraoperatively and within 6 hours postoperatively. | postoperative day 0 |
Daily step count at baseline - number of steps per day |
| 1 - 7 days prior to surgery |
| Daily step count as measured by wearable device at baseline for those scheduled for outpatient surgery. | Daily step count at baseline - number of steps per day | 1 - 7 days prior to surgery |
| Daily step count as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day | 7 - 10 days after surgery |
| Daily step count as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day | 7 - 10 days after surgery |
| Daily step count as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day | 7 - 10 days after surgery |
| Daily step count as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day | 30 - 34 days after surgery |
| Daily step count as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day | 30 - 34 days after surgery |
| Daily step count as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day | 30 - 34 days after surgery |
| Daily standing hours as measured by wearable device at baseline for those scheduled for major inpatient surgery. | Daily standing hours: defined as standing hours per day | 1 - 7 days prior to surgery |
| Daily standing hours as measured by wearable device at baseline for those scheduled for minor inpatient surgery. | Daily standing hours: defined as standing hours per day | 1 - 7 days prior to surgery |
| Daily standing hours as measured by wearable device at baseline for those scheduled for outpatient surgery. | Daily standing hours: defined as standing hours per day | 1 - 7 days prior to surgery |
| Daily standing hours as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable device. Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day | 7 - 10 days after surgery |
| Daily standing hours as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device. Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day | 7 - 10 days after surgery |
| Daily standing hours as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device. Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day | 7 - 10 days after surgery |
| Daily standing hours as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device. Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day | 30 - 34 days after surgery |
| Daily standing hours as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device. Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day | 30 - 34 days after surgery |
| Daily standing hours as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable device. Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day | 30 - 34 days after surgery |
| Total sleep time as measured at baseline by wearable device for those scheduled for outpatient surgery. | Total sleep time defined as minutes of total sleep time per day | 1 - 7 days prior to surgery |
| Total sleep time as measured at baseline by wearable device for those scheduled for major inpatient surgery. | Total sleep time defined as minutes of total sleep time per day | 1 - 7 days prior to surgery |
| Total sleep time as measured at baseline by wearable device for those scheduled for minor inpatient surgery. | Total sleep time defined as minutes of total sleep time per day | 1 - 7 days prior to surgery |
| Total sleep time as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day | 7 - 10 days after surgery |
| Total sleep time as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day | 7 - 10 days after surgery |
| Total sleep time as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day | 7 - 10 days after surgery |
| Total sleep time as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day | 30 - 34 days after surgery |
| Total sleep time as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day | 30 - 34 days after surgery |
| Total sleep time as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day | 30 - 34 days after surgery |
| Sleep onset latency as measured by wearable device at baseline for those scheduled for minor inpatient surgery. | Sleep onset latency: defined as minutes of sleep onset latency per day | 1 - 7 days prior to surgery |
| Sleep onset latency as measured by wearable device at baseline for those scheduled for major inpatient surgery. | Sleep onset latency: defined as minutes of sleep onset latency per day | 1 - 7 days prior to surgery |
| Sleep onset latency as measured by wearable device at baseline for those scheduled for outpatient surgery. | Sleep onset latency: defined as minutes of sleep onset latency per day | 1 - 7 days prior to surgery |
| Sleep onset latency as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day | 7 - 10 days after surgery |
| Sleep onset latency as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day | 7 - 10 days after surgery |
| Sleep onset latency as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day | 7 - 10 days after surgery |
| Sleep onset latency as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day | 30 - 34 days after surgery |
| Sleep onset latency as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day | 30 - 34 days after surgery |
| Sleep onset latency as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day | 30 - 34 days after surgery |
| Wake after sleep onset as measured by wearable device for those scheduled for outpatient surgery. | Wake after sleep onset: defined as minutes of wake after sleep onset | 1 - 7 days prior to surgery |
| Wake after sleep onset as measured by wearable device for those scheduled for major inpatient surgery. | Wake after sleep onset: defined as minutes of wake after sleep onset | 1 - 7 days prior to surgery |
| Wake after sleep onset as measured by wearable device for those scheduled for minor inpatient surgery. | Wake after sleep onset: defined as minutes of wake after sleep onset | 1 - 7 days prior to surgery |
| Wake after sleep onset as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset | 7 - 10 days after surgery |
| Wake after sleep onset as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset | 7 - 10 days after surgery |
| Wake after sleep onset as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset | 7 - 10 days after surgery |
| Wake after sleep onset as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset | 30 - 34 days after surgery |
| Wake after sleep onset as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset | 30 - 34 days after surgery |
| Wake after sleep onset as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset | 30 - 34 days after surgery |
| Sleep efficiency as measured at baseline by wearable device for those scheduled for major inpatient surgery. | Sleep efficiency: defined as % sleep efficiency (ranging from 0-100) | 1 - 7 days prior to surgery |
| Sleep efficiency as measured at baseline by wearable device for those scheduled for minor inpatient surgery. | Sleep efficiency: defined as % sleep efficiency (ranging from 0-100) | 1 - 7 days prior to surgery |
| Sleep efficiency as measured at baseline by wearable device for those scheduled for outpatient surgery. | Sleep efficiency: defined as % sleep efficiency (ranging from 0-100) | 1 - 7 days prior to surgery |
| Sleep efficiency as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100) | 7 - 10 days after surgery |
| Sleep efficiency as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100) | 7 - 10 days after surgery |
| Sleep efficiency as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100) | 7 - 10 days after surgery |
| Sleep efficiency as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100) | 30 - 34 days after surgery |
| Sleep efficiency as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100) | 30 - 34 days after surgery |
| Sleep efficiency as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100) | 30 - 34 days after surgery |
| Midpoint of sleep as measured at baseline by wearable device for those scheduled for outpatient surgery. | Midpoint of sleep: defined as midpoint of sleep (time) | 1 - 7 days prior to surgery |
| Midpoint of sleep as measured at baseline by wearable device for those scheduled for minor inpatient surgery. | Midpoint of sleep: defined as midpoint of sleep (time) | 1 - 7 days prior to surgery |
| Midpoint of sleep as measured at baseline by wearable device for those scheduled for major inpatient surgery. | Midpoint of sleep: defined as midpoint of sleep (time) | 1 - 7 days prior to surgery |
| Midpoint of sleep as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time) | 7 - 10 days after surgery |
| Midpoint of sleep as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time) | 7 - 10 days after surgery |
| Midpoint of sleep as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time) | 7 - 10 days after surgery |
| Midpoint of sleep as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time) | 30 - 34 days after surgery |
| Midpoint of sleep as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time) | 30 - 34 days after surgery |
| Midpoint of sleep as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time) | 30 - 34 days after surgery |
| Allison Janda, MD |
| University of Michigan |
| Study Director |
| Mark Neuman, MD | University of Pennsylvania | Study Director |
| Bethany Pennington, PharmD | Washington University School of Medicine | Study Director |
| Douglas Colquhoun, MBChB | University of Michigan | Study Director |
| University of California San Francisco | Recruiting | San Francisco | California | 94143 | United States |
|
| Stanford University | Not yet recruiting | Stanford | California | 94305 | United States |
|
| Yale School of Medicine | Recruiting | New Haven | Connecticut | 06510 | United States |
|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
|
| Brigham & Women's | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
|
| Henry Ford Health | Recruiting | Detroit | Michigan | 48202 | United States |
|
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
|
| Dartmouth Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03756 | United States |
|
| NYU Langone | Recruiting | New York | New York | 10012 | United States |
|
| Weill Cornell Medicine | Recruiting | New York | New York | 10065 | United States |
|
| Duke University | Recruiting | Durham | North Carolina | 27708 | United States |
|
| Wake Forest | Recruiting | Winston-Salem | North Carolina | 27109 | United States |
|
| Oregon Health and Sciences University | Recruiting | Portland | Oregon | 97239 | United States |
|
| University of Pennsylvania | Not yet recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| University of Texas - MD Anderson | Recruiting | Houston | Texas | 77030 | United States |
|
| University of Utah - Medical | Recruiting | Salt Lake City | Utah | 84132 | United States |
|
| UVA Health | Recruiting | Charlottesville | Virginia | 22908 | United States |
|
| University of Washington | Recruiting | Seattle | Washington | 98195 | United States |
|
| ID | Term |
|---|---|
| D058926 | Intraoperative Awareness |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D007431 | Intraoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided