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Behavioural Intervention

Sedline EEG in View for Anesthesia

N/A

Waitlist Available

Led By Timothy Webb, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or Female

Be older than 65 years old

Must not have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours

Awards & highlights

No Placebo-Only Group

Study Summary

This trial will see if using a Sedline Monitor to monitor sedation levels in patients under general anesthesia affects how much anesthesia they receive.

Eligible Conditions

Anesthesia
Surgery

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

Both males and females can participate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Anesthetics

Secondary outcome measures

Total Hypnotic agents

episodes of hypotension

occurrence of EEG isoelctricity

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Study GroupExperimental Treatment1 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 study group, the monitor will be in full view of the anesthesiologist administering the anesthetic.

Group II: Control GroupActive Control1 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sedline EEG in View

2021

N/A

~110

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

949 Previous Clinical Trials

776,941 Total Patients Enrolled

Timothy Webb, MDPrincipal InvestigatorIndiana University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant cap for this research study?

"Affirmative. The clinical trial information hosted on clinicaltrials.gov indicates that this medication is accepting 110 participants from one site, with the initial posting occurring on June 30th 2021 and updated most recently on December 17th 2021."

Answered by AI

Is enrollment still open for this research endeavor?

"Affirmative. According to the clinical trial's entry on clinicaltrials.gov, recruitment is still underway for this investigation which was initially posted on June 30th 2021 and refreshed most recently on December 17th 2021. The study requires 110 participants across a single medical facility."

Answered by AI

Recent research and studies

JamaJournal

Effect of Electroencephalography-guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery

Wildes, Troy S., Angela M. Mickle, Arbi Ben Abdallah, Hannah R. Maybrier, Jordan Oberhaus, Thaddeus P. Budelier, Alex Kronzer, et al.. 2019. “Effect of Electroencephalography-guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery”. Jama. American Medical Association (AMA). doi:10.1001/jama.2018.22005.

AnaesthesiaJournal

The Role and Limitations of Eeg-based Depth of Anaesthesia Monitoring in Theatres and Intensive Care

Hajat, Z., N. Ahmad, and J. Andrzejowski. 2017. “The Role and Limitations of Eeg-based Depth of Anaesthesia Monitoring in Theatres and Intensive Care”. Anaesthesia. Wiley. doi:10.1111/anae.13739.

JamaJournal

Effect of Electroencephalography-guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery

AnesthesiologyJournal

Processed Electroencephalogram Monitoring and Postoperative Delirium