N/A
N=110
Sedline EEG Guided Depth of Anesthesia
Anesthesia · Surgery
Bottom Line
View on ClinicalTrials.gov: NCT05051982 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Total Average Anesthetic — 1.1890; 1.2906 percentage of sevoflurane
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sedline EEG in View (Device)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Average Anesthetic |
1.1890; 1.2906 | — |
| SECONDARY Total Hypnotic Agents (Midazolam, Ketamine, Methadone, Hydromorphone) |
1.29; 1.49; 43.98; 45.40; 0.39; 0.41 | — |
| SECONDARY Time Period of Hypotension |
27.18; 27.41 | — |
| SECONDARY Total Dosage of Vasopressor (Norepinephrine, Phenylephrine) |
1442.55; 4077.20; 79.45; 374.62 | — |
| SECONDARY Occurrence of EEG Isoelctricity |
13.60; 21.28 | — |
| SECONDARY Total Dosage of Vasopressor (Ephedrine) |
17.06; 13.86 | — |
| SECONDARY Total Dosage of Vasopressor (Vasopressin) |
0.84; 2.63 | — |
| SECONDARY Total Hypnotic Agents (Fentanyl) |
139.22; 173.04 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05051982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.