Clinical trial NCT03241004: Does Melatonin Affect Anesthetic MAC (Minimum Alveolar Concentration)?
Official title: Does Melatonin Affect Anesthetic MAC (Minimum Alveolar Concentration)?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Englewood Hospital and Medical Center
Sponsor class: OTHER
First posted: 2017-08-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: EEG data
timeFrame: 2 hours
Secondary outcomes:
measure: Subject perception of depth of anesthesia
timeFrame: within 24 hours of reversal of sedation
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
Study officials:
affiliation: Englewood Hospital and Medical Center
name: Jeff Smok, MD
role: PRINCIPAL_INVESTIGATOR
References: