Does Melatonin Affect Anesthetic MAC (Minimum Alveolar Concentration)?

Anesthesia Clinical Trial

Official title:

Does Melatonin Affect Anesthetic MAC (Minimum Alveolar Concentration)?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03241004
• Other study ID #: E-17-705
• Status: Terminated
• Phase: N/A
• Start date: July 7, 2017
• Est. completion date: July 8, 2021

Study information

• Verified date: August 2021
• Source: Englewood Hospital and Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: July 8, 2021
• Est. primary completion date: July 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Other:
• Sleep Mask
sleep mask applied for two separate 60-minute periods during anesthesia

Locations

Country	Name	City	State
United States	Englewood Hospital and Medical Center	Englewood	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Englewood Hospital and Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG data	change in depth of anesthesia from baseline to two hours	2 hours
Secondary	Subject perception of depth of anesthesia	post-procedure evaluation	within 24 hours of reversal of sedation

External Links

•   Related Info