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The purpose of our study is to determine if monitoring sedation (how asleep patients are under general anesthesia) using a device called a Sedline Monitor affects the amount of anesthesia patients receive.
The main objective of this study is to determine if monitoring sedation using the FDA approved device, Sedline Monitor, affects the amount of anesthesia patients 65 or older receive during surgery. Reducing the anesthetic dose could result in less exposure of anesthetic medications to a high-risk patient population as well as a potential reduction in cost. Subjects will be randomized into either a control group or study group and have the Sedline Monitor placed on their head before the start of their already scheduled surgery. During the surgery, subjects in the control group will receive standard anesthesia care and the study group will receive anesthetic drug doses guided by Sedline Monitor processed EEG characteristics. When the surgery is complete, the Sedline Monitor will be removed and subject participation will be finished. The study team will also collect information about subjects from their medical records and use it for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the study group, the monitor will be in full view of the anesthesiologist administering the anesthetic. |
|
| Control Group | No Intervention | Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the control group, an apparatus will be placed over the monitor will not be in view of the anesthesiologist. The |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sedline EEG in View | Device | EEG monitor (Sedline) will be in full view of the Anesthesiologist during surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Average Anesthetic | total average percent of volatile anesthetic (sevoflurane) utilized while subjects are under anesthesia (maintenance phase). | 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given |
| Measure | Description | Time Frame |
|---|---|---|
| Total Hypnotic Agents (Midazolam, Ketamine, Methadone, Hydromorphone) | the total dosage of hypnotic agents administered while in the maintenance phase of anesthesia. These agents include: midazolam, methadone, and hydromorphone. | 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Webb, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health University Hospital | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28044337 | Background | Hajat Z, Ahmad N, Andrzejowski J. The role and limitations of EEG-based depth of anaesthesia monitoring in theatres and intensive care. Anaesthesia. 2017 Jan;72 Suppl 1:38-47. doi: 10.1111/anae.13739. | |
| 29912008 | Background | MacKenzie KK, Britt-Spells AM, Sands LP, Leung JM. Processed Electroencephalogram Monitoring and Postoperative Delirium: A Systematic Review and Meta-analysis. Anesthesiology. 2018 Sep;129(3):417-427. doi: 10.1097/ALN.0000000000002323. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group | Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the study group, the monitor will be in full view of the anesthesiologist administering the anesthetic. Sedline EEG in View: EEG monitor (Sedline) will be in full view of the Anesthesiologist during surgery. |
| FG001 | Control Group | Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the control group, an apparatus will be placed over the monitor will not be in view of the anesthesiologist. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group | Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the study group, the monitor will be in full view of the anesthesiologist administering the anesthetic. Sedline EEG in View: EEG monitor (Sedline) will be in full view of the Anesthesiologist during surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Total Average Anesthetic | total average percent of volatile anesthetic (sevoflurane) utilized while subjects are under anesthesia (maintenance phase). | Posted | Mean | Standard Deviation | percentage of sevoflurane | 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given |
|
Approx 24 hrs.
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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 | Study Group | Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the study group, the monitor will be in full view of the anesthesiologist administering the anesthetic. Sedline EEG in View: EEG monitor (Sedline) will be in full view of the Anesthesiologist during surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Timothy Webb | Indiana University School of Medicine (Dept of Anesthesia) | 2196893636 | ttwebb@iu.edu |
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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 | Jan 28, 2021 | Jul 9, 2021 | Prot_SAP_000.pdf |
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| Time Period of Hypotension |
this will be defined as an episode of mean arterial pressure of <65 mmHg |
| 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given |
| Total Dosage of Vasopressor (Norepinephrine, Phenylephrine) | phenylephrine, norepinephrine | 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given |
| Occurrence of EEG Isoelctricity | Following the procedure, images and data from the Sedline device were evaluated to determine what percentage of the case a patient's processed EEG displayed isoelectricity (burst suppression). A burst-suppression (or suppression-burst) pattern is a discontinuous EEG, with periods of marked suppression or isoelectric intervals alternating with "bursts" of activity, with or without embedded epileptiform features (Bauer et al., 2013) | 5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours |
| Total Dosage of Vasopressor (Ephedrine) | ephedrine | 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given |
| Total Dosage of Vasopressor (Vasopressin) | vasopressin | 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given |
| Total Hypnotic Agents (Fentanyl) | the total dosage of hypnotic agents administered while in the maintenance phase of anesthesia; fentanyl. | 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given |
| 26275092 | Background | Purdon PL, Sampson A, Pavone KJ, Brown EN. Clinical Electroencephalography for Anesthesiologists: Part I: Background and Basic Signatures. Anesthesiology. 2015 Oct;123(4):937-60. doi: 10.1097/ALN.0000000000000841. |
| 30721296 | Background | Wildes TS, Mickle AM, Ben Abdallah A, Maybrier HR, Oberhaus J, Budelier TP, Kronzer A, McKinnon SL, Park D, Torres BA, Graetz TJ, Emmert DA, Palanca BJ, Goswami S, Jordan K, Lin N, Fritz BA, Stevens TW, Jacobsohn E, Schmitt EM, Inouye SK, Stark S, Lenze EJ, Avidan MS; ENGAGES Research Group. Effect of Electroencephalography-Guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery: The ENGAGES Randomized Clinical Trial. JAMA. 2019 Feb 5;321(5):473-483. doi: 10.1001/jama.2018.22005. |
| Background | 4. Kaplan LJ, Bailey H. Bispectral index (BIS) monitoring of ICU patients on continuous infusion of sedatives and paralytics reduces sedative drug utilization and cost. |
| 21048097 | Background | Ishizawa Y. Special article: general anesthetic gases and the global environment. Anesth Analg. 2011 Jan;112(1):213-7. doi: 10.1213/ANE.0b013e3181fe02c2. Epub 2010 Nov 3. |
| BG001 | Control Group | Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the control group, an apparatus will be placed over the monitor will not be in view of the anesthesiologist. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| 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 |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| BMI | Mean | Standard Deviation | kilograms / meters^2 |
|
| Baseline Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| Baseline Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| ASA physical status | The American Society of Anesthesiologists (ASA) physical status classification system is used to evaluate fitness of patients before surgery.
| Count of Participants | Participants |
|
| Opioid Naïve or Tolerant | Count of Participants | Participants |
|
| Type of Surgery | Count of Participants | Participants |
|
Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the control group, an apparatus will be placed over the monitor will not be in view of the anesthesiologist.
|
|
| Secondary | Total Hypnotic Agents (Midazolam, Ketamine, Methadone, Hydromorphone) | the total dosage of hypnotic agents administered while in the maintenance phase of anesthesia. These agents include: midazolam, methadone, and hydromorphone. | Posted | Mean | Standard Deviation | mg | 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given |
|
|
|
| Secondary | Time Period of Hypotension | this will be defined as an episode of mean arterial pressure of <65 mmHg | Posted | Mean | Standard Deviation | minutes (with MAP < 65) | 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given |
|
|
|
| Secondary | Total Dosage of Vasopressor (Norepinephrine, Phenylephrine) | phenylephrine, norepinephrine | Please note, the units listed below are the standard units used in clinical practice for these medications | Posted | Mean | Standard Deviation | mcg | 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given |
|
|
|
| Secondary | Occurrence of EEG Isoelctricity | Following the procedure, images and data from the Sedline device were evaluated to determine what percentage of the case a patient's processed EEG displayed isoelectricity (burst suppression). A burst-suppression (or suppression-burst) pattern is a discontinuous EEG, with periods of marked suppression or isoelectric intervals alternating with "bursts" of activity, with or without embedded epileptiform features (Bauer et al., 2013) | Posted | Mean | Standard Deviation | % (of case with burst suppression) | 5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours |
|
|
|
| Secondary | Total Dosage of Vasopressor (Ephedrine) | ephedrine | Posted | Mean | Standard Deviation | mg | 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given |
|
|
|
| Secondary | Total Dosage of Vasopressor (Vasopressin) | vasopressin | Posted | Mean | Standard Deviation | Units | 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given |
|
|
|
| Secondary | Total Hypnotic Agents (Fentanyl) | the total dosage of hypnotic agents administered while in the maintenance phase of anesthesia; fentanyl. | Posted | Mean | Standard Deviation | mcg | 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Control Group | Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the control group, an apparatus will be placed over the monitor will not be in view of the anesthesiologist. | 0 | 55 | 0 | 55 | 0 | 55 |
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| Hydromorphone |
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| Methadone |
|