Sedline EEG Guided Depth of Anesthesia
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Device: Sedline EEG in View
EEG monitor (Sedline) will be in full view of the Anesthesiologist during surgery.
|
| No Intervention: 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. The |
Outcome Measures
Primary Outcome Measures
- Total Average Anesthetic [5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours]
total average percent of volatile anesthetic (sevoflurane) utilized while subjects are under anesthesia (maintenance phase).
Secondary Outcome Measures
- Total Hypnotic agents [5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours]
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.
- episodes of hypotension [5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours]
this will be defined as an episode of mean arterial pressure of <65 mmHg
- total dosage of vasopressors [5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours]
such as phenylephrine, ephedrine, vasopressin, or norepinephrine
- occurrence of EEG isoelctricity [5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours]
burst suppression
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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ASA class 1, 2, 3, or 4.
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Age 65 years or older.
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Male or Female
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Surgical procedure requiring general anesthesia.
Exclusion Criteria:
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Any previous diagnosis of dementia or other cognitive impairment.
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Any patient undergoing emergency surgery.
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Any patient undergoing surgery who is currently an inpatient.
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Patient refusal to participate in study.
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Any patient undergoing surgery that would prevent placement of the Sedline monitor leads (for example - surgery on the patient's forehead/scalp).
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IU Health University Hospital | Indianapolis | Indiana | United States | 46202 |
Sponsors and Collaborators
- Indiana University
Investigators
- Principal Investigator: Timothy Webb, MD, Indiana University
Study Documents (Full-Text)
More Information
Publications
- 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.
- 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. Review.
- 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. Review.
- 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.
- 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. Review.
- 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.
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