Anesthesia
Conditions
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.
Interventions
OTHERSleep Mask
sleep mask applied for two separate 60-minute periods during anesthesia
Sponsors
Englewood Hospital and Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EEG data | 2 hours | change in depth of anesthesia from baseline to two hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject perception of depth of anesthesia | within 24 hours of reversal of sedation | post-procedure evaluation |
Countries
United States
Outcome results
None listed