Does Melatonin Affect Anesthetic MAC (Minimum Alveolar Concentration)?



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:6/16/2018
Start Date:July 7, 2017
End Date:June 2019
Contact:Jeff Smok, MD
Email:jeff.smok@ehmchealth.org
Phone:201-894-3238

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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.

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.
We found this trial at
1
site
350 Engle St
Englewood, New Jersey 07631
(201) 894-3000
Principal Investigator: Jeff Smok, MD
Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
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mi
from
Englewood, NJ
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