Sedline EEG Guided Depth of Anesthesia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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SedLine EEG-Guided Depth of Anesthesia: Effect of Anesthetic Dosage

Conditions
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Anesthesia, Surgery

Intervention / Treatment
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* Device: Sedline EEG in View


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing a scheduled surgery (laparotomy, hepatobiliary surgery, gynecologic surgery, and/or urologic surgery procedures) at Indiana University Health University Hospital that is expected to have at least a 3 day post-operative hospital stay. ASA class 1, 2, 3, or 4. Age 65 years or older. Male or Female Surgical procedure requiring general anesthesia. Exclusion Criteria: Any previous diagnosis of dementia or other cognitive impairment. Any patient undergoing emergency surgery. Any patient undergoing surgery who is currently an inpatient. Patient refusal to participate in study. Any patient undergoing surgery that would prevent placement of the Sedline monitor leads (for example - surgery on the patient's forehead/scalp). Any physical, mental, or medical conditions which, in the opinion of the investigators, may confound the ability to assess the patient for delirium in the post-operative period.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>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. | Device: Sedline EEG in View<br>* EEG monitor (Sedline) will be in full view of the Anesthesiologist during surgery.<br>|
| No Intervention: Control Group<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 administration of neuromuscular blocker reversal drugs up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Hypnotic agents | the total dosage of hypnotic agents administered while in the maintenance phase of anesthesia. These agents include: midazolam, lorazepam, diazepam, fentanyl, sufentanil, ketamine, propofol, morphine, and hydromorphone. | 5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours | 
| episodes of hypotension | this will be defined as an episode of mean arterial pressure of <65 mmHg | 5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours | 
| total dosage of vasopressors | such as phenylephrine, ephedrine, vasopressin, or norepinephrine | 5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours | 
| occurrence of EEG isoelctricity | burst suppression | 5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours |