Does Melatonin Affect Anesthetic MAC (Minimum Alveolar Concentration)?

Not Applicable

Terminated

• Conditions: Anesthesia
• Interventions: Other: Sleep Mask

• Registration Number: NCT03241004
• Lead Sponsor: Englewood Hospital and Medical Center

Brief Summary

This study aims to determine if anesthetic depth can be deepened non-pharmacologically through use of sleep masks. This study seeks to demonstrate a relationship between the depth of anesthesia with application of sleep masks intraoperatively and in the critical care setting.

Detailed Description

Depth of anesthesia will be monitored, both with a standard sleep mask applied and without, in each subject using standard electroencephalogram (EEG) readings via forehead leads and Masimo Sedline 2.0 4-lead EEG monitors.

OR Subjects:

Patients will be induced in a standard fashion using intravenous (IV) anesthetics. A continuous administration of propofol and inhalational anesthetics will be used for maintenance of anesthesia. The standard electroencephalogram (EEG) reading via forehead leads and Masimo Sedline 2.0 4-lead EEG machines will be used to monitor the depth of anesthesia, both with and without the sleep mask.

ICU Subjects:

Patients will be induced in a standard fashion using intravenous (IV) anesthetics. A continuous administration of propofol will be used for maintenance of anesthesia. The standard electroencephalogram (EEG) reading via Masimo Sedline 2.0 4-lead EEG monitors will be used to track the depth of anesthesia, both with and without the sleep mask.

All Subjects:

In both settings,once baseline EEG readings are established (30 minutes), EEG data will be recorded and a sleep mask will be applied to the patient for one hour. After one hour (90 minutes), EEG data will be recorded and the sleep mask will be removed. After another hour (150 minutes), EEG data will be recorded and the mask reapplied. After another hour (210 minutes), EEG data will be recorded and the mask removed. The levels/doses of anesthetic agent at each time point will also be recorded.

Subjective perception of depth of anesthesia will be obtained by means of a post-procedure evaluation administered to each subject.

Study Timeline

• Study Start: 2017-07-07
• Study First Submitted: 2017-08-02
• Study First Submitted QC: 2017-08-04
• Study First Posted: 2017-08-07
• Primary Completion: 2021-07-08
• Study Completion: 2021-07-08
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-16
• Last Update Posted: 2021-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Male or female at least 18 years of age.
• Not pregnant.

Exclusion Criteria

• Undergoing surgeries expected to last less than 3 hours.
• Undergoing vascular or neurosurgical procedures.
• Patients with history of CVA (Cardiovascular accidents or disease) or other neurological dysfunction.
• Patients or authorized representatives unable or unwilling to provide informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive Care Unit	Sleep Mask	Patients will be induced in a standard fashion using intravenous (IV) anesthetics. A continuous administration of propofol will be used for maintenance of anesthesia. Baseline EEG readings will be established for 30 minutes, then EEG data will be recorded and a sleep mask applied to the patient for one hour. After one hour, eye masks will be removed for an hour and reapplied after another hour. During the hour that the mask is off, 2 hours into sedation, EEG data will again be recorded.
Operating Room	Sleep Mask	Patients will be induced in a standard fashion using intravenous (IV) anesthetics. A continuous administration of propofol and inhalational anesthetics will be used for maintenance of anesthesia. Baseline EEG readings will be established for 30 minutes, then EEG data will be recorded and a sleep mask applied to the patient for one hour. After one hour, eye masks will be removed for an hour and reapplied after another hour. During the hour that the mask is off, 2 hours into sedation, EEG data will again be recorded.

Primary Outcome Measures

Name	Time	Method
EEG data	2 hours	change in depth of anesthesia from baseline to two hours

Secondary Outcome Measures

Name	Time	Method
Subject perception of depth of anesthesia	within 24 hours of reversal of sedation	post-procedure evaluation

Trial Locations

Locations (1)

Englewood Hospital and Medical Center; 🇺🇸 Englewood, New Jersey, United States