Does Melatonin Affect Anesthetic MAC (Minimum Alveolar Concentration)?

Englewood Hospital and Medical Center12 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Anesthesia

Interventions

Sleep MaskOTHER

sleep mask applied for two separate 60-minute periods during anesthesia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Englewood Hospital and Medical Center

Englewood, New Jersey, United States

Outcomes

Primary Outcomes

EEG data

change in depth of anesthesia from baseline to two hours

Time frame: 2 hours

Secondary Outcomes

Subject perception of depth of anesthesia

post-procedure evaluation

Time frame: within 24 hours of reversal of sedation

Data from ClinicalTrials.gov

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