Does Melatonin Affect Anesthetic MAC (Minimum Alveolar Concentration)?

NCT ID: NCT03241004

Last Updated: 2021-08-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-07
• Study Completion Date: 2021-07-08

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.

Conditions

Anesthesia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intensive Care Unit

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.

Group Type: EXPERIMENTAL

Sleep Mask

Intervention Type: OTHER

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

Operating Room

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.

Group Type: EXPERIMENTAL

Sleep Mask

Intervention Type: OTHER

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

Interventions

Sleep Mask

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Englewood Hospital and Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeff Smok, MD

Role: PRINCIPAL_INVESTIGATOR

Englewood Hospital and Medical Center

Locations

Englewood Hospital and Medical Center

Englewood, New Jersey, United States

Countries

United States

Related Links

http://www.englewoodhealth.org/for-healthcare-professionals/clinical-research-center

Related Info

Other Identifiers

E-17-705

Identifier Type: -

Identifier Source: org_study_id