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| Name | Class |
|---|---|
| Virginia Mason Hospital/Medical Center | OTHER |
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A comparison of post-operative opioid use in laparoscopic bariatric surgery patients receiving opioid or opioid-free anesthesia.
This is a prospective, single-center, single-blinded, randomized controlled trial comparing the effect of an opioid-free general anesthetic versus a traditional anesthetic with a restricted quantity of opioid on postoperative opioid consumption following laparoscopic bariatric surgery. The study population will be composed of 196 subjects undergoing laparoscopic bariatric surgery at Virginia Mason Medical center randomized into two groups. The control group will receive a traditional opioid restrictive general anesthetic. The study group will receive an opioid-free anesthetic technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Goup A- Opioid-based regimen | Active Comparator | Preop - Multimodals unless contraindicated Induction
Maintenance
Emergence
PACU opioid orders per anesthesiology team Post-operative Nausea/Vomiting Prophylaxis -4mg dexamethasone, 1mg haloperidol, scopolamine patch |
|
| Experimental Group B- Opioid-free regimen | Experimental | Preop - Multimodals unless contraindicated Induction
Maintenance
Emergence
Post-operative Nausea/Vomiting Prophylaxis -4mg dexamethasone, 1mg haloperidol, scopolamine patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid Anesthetics | Drug | see arm/group description |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24 Hour Opioid Consumption | Total amount of opioid use within the first 24 hours after surgery in mg of oral morphine equivalent doses | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Time Under General Anesthesia | Time from induction to emergence of anesthesia | 1-5 hours |
| Percentage of Patients With Opioid-related Adverse Effects | Adverse effects include postoperative nausea, vomiting, pruritis, and respiratory depression. Some subjective, patient-reported data collection failed; these participants were excluded from this outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Oryhan, MD | Virginia Mason Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Goup A- Opioid-based Regimen | Preop - Multimodals unless contraindicated Induction
Maintenance
Emergence
PACU opioid orders per anesthesiology team Post-operative Nausea/Vomiting Prophylaxis -4mg dexamethasone, 1mg haloperidol, scopolamine patch Opioid Anesthetics: see arm/group description |
| FG001 | Experimental Group B- Opioid-free Regimen | Preop - Multimodals unless contraindicated Induction
Maintenance
Emergence
Post-operative Nausea/Vomiting Prophylaxis -4mg dexamethasone, 1mg haloperidol, scopolamine patch Non Opioid Analgesics: see arm/group description |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Goup A- Opioid-based Regimen | Preop - Multimodals unless contraindicated Induction
Maintenance
Emergence
PACU opioid orders per anesthesiology team Post-operative Nausea/Vomiting Prophylaxis -4mg dexamethasone, 1mg haloperidol, scopolamine patch Opioid Anesthetics: see arm/group description |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 24 Hour Opioid Consumption | Total amount of opioid use within the first 24 hours after surgery in mg of oral morphine equivalent doses | Posted | Mean | Standard Deviation | mg oral morphine equivalents (OMEs) | 24 hours |
|
3 months
Some subjective, patient-reported data collection failed; these participants were excluded from these outcome.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Goup A- Opioid-based Regimen | Preop - Multimodals unless contraindicated Induction
Maintenance
Emergence
PACU opioid orders per anesthesiology team Post-operative Nausea/Vomiting Prophylaxis -4mg dexamethasone, 1mg haloperidol, scopolamine patch Opioid Anesthetics: see arm/group description |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oxygen requirement beyond postanesthesia care unit | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Oryhan | Virginia Mason Medical Center | 206-223-6980 | christine.oryhan@virginiamason.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2022 | Oct 3, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 18, 2022 | Oct 3, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D018712 | Analgesics, Non-Narcotic |
| ID | Term |
|---|---|
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
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The investigators plan to enroll 196 subjects at Virginia Mason Medical Center that are undergoing laparoscopic bariatric surgery. Subjects who volunteer to be involved in the study will be randomized to either the opioid free or traditional anesthetic arm, with a computer generated arm assignment. Subjects will be blinded to the assigned arm. Group A will receive a traditional opioid restrictive general anesthetic and group B will receive an opioid-free anesthetic technique.
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| Non Opioid Analgesics | Drug | see arm/group description |
|
|
| 24 hours |
| Length of Time to Recover From General Anesthesia | Time from arrival to PACU to "ready for PACU discharge" | 1-3 hours |
| Length of Hospital Stay | Time from PACU arrival to discharge date and time in days | 1-5 days |
| Overall Patient Satisfaction With Analgesia: Yes or no | Number of Participants With Overall Patient Satisfaction With Analgesia | 24 hours |
| Number of Participants With Post-surgical Opioid Prescription Refills up to 30 Days | Number of participates with opioid prescription refills since surgery within 30 day after surgery | 30 days |
| Percentage of Patients Treated for General Anesthetic Adverse Effects | Episodes of severe bradycardia or treated hypotension intraoperatively | Intraoperative, between time entering OR and PACU arrival time |
| Number of Participants With Post-surgical Opioid Prescription Refills Between 30 Days to 3 Months After Surgery | Number of participates with opioid prescription refills since surgery between 30 day and 3 months after surgery | 3 months |
| BG001 | Experimental Group B- Opioid-free Regimen | Preop - Multimodals unless contraindicated Induction
Maintenance
Emergence
Post-operative Nausea/Vomiting Prophylaxis -4mg dexamethasone, 1mg haloperidol, scopolamine patch Non Opioid Analgesics: see arm/group description |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Weight | Median | Inter-Quartile Range | kilograms |
|
| Ideal Body Weight (IBW) | Median | Inter-Quartile Range | kilograms |
|
| Body Mass Index | Median | Inter-Quartile Range | kilograms/meter^2 |
|
| American Society of Anesthesiologists (ASA) class | ASA classification ranges from 1 - 6 based on a patient's preoperative comorbid conditions. ASA classification is a grading system used by anesthesiologists to assess a patient's health before surgery. The system assigns a patient a score from ASA 1 to ASA 6, with higher numbers indicating a higher risk of complications. The ASA classification system is used in conjunction with other factors, such as the type of surgery, to help predict the risk of surgery. | Count of Participants | Participants |
|
| OG001 | Experimental Group B- Opioid-free Regimen | Preop - Multimodals unless contraindicated Induction
Maintenance
Emergence
Post-operative Nausea/Vomiting Prophylaxis -4mg dexamethasone, 1mg haloperidol, scopolamine patch Non Opioid Analgesics: see arm/group description |
|
|
| Secondary | Length of Time Under General Anesthesia | Time from induction to emergence of anesthesia | Posted | Mean | Standard Deviation | hours | 1-5 hours |
|
|
|
| Secondary | Percentage of Patients With Opioid-related Adverse Effects | Adverse effects include postoperative nausea, vomiting, pruritis, and respiratory depression. Some subjective, patient-reported data collection failed; these participants were excluded from this outcome. | Some subjective, patient-reported data collection failed; these participants were excluded from this outcome | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Secondary | Length of Time to Recover From General Anesthesia | Time from arrival to PACU to "ready for PACU discharge" | Posted | Mean | Standard Deviation | hours | 1-3 hours |
|
|
|
| Secondary | Length of Hospital Stay | Time from PACU arrival to discharge date and time in days | Posted | Mean | Standard Deviation | days | 1-5 days |
|
|
|
| Secondary | Overall Patient Satisfaction With Analgesia: Yes or no | Number of Participants With Overall Patient Satisfaction With Analgesia | Some subjective, patient-reported data collection failed; these participants were excluded from this outcome | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Secondary | Number of Participants With Post-surgical Opioid Prescription Refills up to 30 Days | Number of participates with opioid prescription refills since surgery within 30 day after surgery | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Percentage of Patients Treated for General Anesthetic Adverse Effects | Episodes of severe bradycardia or treated hypotension intraoperatively | Lowest intra-op heart rate less than 50 beats per minute | Posted | Count of Participants | Participants | Intraoperative, between time entering OR and PACU arrival time |
|
|
|
| Secondary | Number of Participants With Post-surgical Opioid Prescription Refills Between 30 Days to 3 Months After Surgery | Number of participates with opioid prescription refills since surgery between 30 day and 3 months after surgery | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 86 |
| 0 |
| 86 |
| 51 |
| 86 |
| EG001 | Experimental Group B- Opioid-free Regimen | Preop - Multimodals unless contraindicated Induction
Maintenance
Emergence
Post-operative Nausea/Vomiting Prophylaxis -4mg dexamethasone, 1mg haloperidol, scopolamine patch Non Opioid Analgesics: see arm/group description | 0 | 95 | 0 | 95 | 62 | 95 |
| Experienced vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Experienced pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Severe bradycardia | Cardiac disorders | Systematic Assessment | Intraoperative heart rate less than 50 beats per minute |
|
| Experienced sedation beyond postanesthesia care unit | Nervous system disorders | Systematic Assessment |
|
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| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| Experienced pruritis |
|
|
| Oxygen requirement beyond postanesthesia care unit |
|
|
| Received ephedrine intraoperatively |
|