Does Melatonin Affect Anesthetic MAC (Minimum Alveolar Concentration)?

NCT03241004 | Terminated

• 1 other identifier: E-17-705
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• EEG data

  change in depth of anesthesia from baseline to two hours

  2 hours

Secondary Outcomes (1)

• Subject perception of depth of anesthesia

  within 24 hours of reversal of sedation

Study Arms (2)

Intensive Care Unit

EXPERIMENTAL

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.

Other: Sleep Mask

Operating Room

EXPERIMENTAL

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.

Other: Sleep Mask

Interventions

Sleep Mask OTHER

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

Intensive Care Unit; Operating Room

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Englewood Hospital and Medical Center: lead

Study Sites (1)

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

Related Links

• Related Info

Study Officials

• Jeff Smok, MD

  Englewood Hospital and Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 7, 2017
• Study Start: July 7, 2017
• Primary Completion: July 8, 2021
• Study Completion: July 8, 2021
• Last Updated: August 20, 2021

Record last verified: 2021-08

Locations

US (1)