Orexin-A Levels in Insomnia Patients

Comparison of Plasma Orexin-A Levels and Awakening Time From Anesthesia in Patients With and Without Insomnia Who Had Laparoscopic Cholecystectomy Under General Anesthesia

In the pathophysiology of insomnia, the increase of the orexin-A (OXA) peptide released from orexin neurons in the lateral hypothalamus plays an important role. Orexins takes part at the emergence of anesthesia. In the literature, investigators could not attain any studies about the arousal of insomnia patients from anesthesia. In this study, the effect of this peptide on the emergence process from anesthesia was investigated by comparing plasma OXA levels before and after anesthesia in insomnia patients.

Study Overview

• Status: Completed
• Conditions: Insomnia; Anesthesia
• Intervention / Treatment: Diagnostic test: Jenkins Sleep Disorders scale and Epworth Sleepiness scale

Detailed Description

ASA (American Society of Anesthesiologists) I-II patients aged 18-65 years who underwent elective laparoscopic cholecystectomy were included in the study. Patients were evaluated with the Jenkins Sleep Disorders scale and Epworth Sleepiness scale during preoperative examination and were divided into insomnia and control groups. Blood samples were obtained for OXA and glucose levels at anesthesia induction, 5 minutes after extubation and 30 minutes after extubation. The times from stopping anesthesia to eyes opening and extubation and end-tidal sevoflurane concentrations at these time points were recorded.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Turkey
  • Mugla, Turkey, 48000
    • Mugla Sitki Kocman University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Male patients undergo elective laparoscopic cholecystectomy under general anesthesia

Description

Inclusion Criteria:

• male patients undergo elective laparoscopic cholecystectomy under general anesthesia
• Between 18-65 age
• ASA I-II

Exclusion Criteria:

• ASA≥III
• Patients with obstructive sleep apnea syndrome
• Bleeding over 500 ml
• Allergic to anesthetic agents
• Patients with a BMI > 30 kg/m2

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
insomnia patients; Jenkins Sleep Disorders scale skor >1 and Epworth Sleepiness scale skor >9	Diagnostic test: Jenkins Sleep Disorders scale and Epworth Sleepiness scale; Jenkins Sleep Disorders scale and Epworth Sleepiness scale
noninsomniacs; Jenkins Sleep Disorders scale skor <2 and Epworth Sleepiness scale skor <10	Diagnostic test: Jenkins Sleep Disorders scale and Epworth Sleepiness scale; Jenkins Sleep Disorders scale and Epworth Sleepiness scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Orexin-A Levels	plasma OXA levels anesthesia induction and after anesthesia in insomnia patients	at anesthesia induction, 5 minutes after extubation and 30 minutes after extubation
Orexin-A Levels	plasma OXA levels anesthesia induction and after anesthesia in control group	at anesthesia induction, 5 minutes after extubation and 30 minutes after extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recovery time from general anesthesia	The relationship between plasma OXA levels and recovery times from anesthesia in insomnia patients	time of eyes opening and time of extubation

Collaborators and Investigators

• Sponsor: Muğla Sıtkı Koçman University
• Investigators: Principal Investigator: melike Korkmaz Toker, Mugla Sıtkı Kocman University Department of Anesthesiology and Reanimation

Publications and helpful links

General Publications

• Bollu PC, Kaur H. Sleep Medicine: Insomnia and Sleep. Mo Med. 2019 Jan-Feb;116(1):68-75.
• Hirota K. [Orexinergic neurons and noradrenergic awakening system in general anesthesia]. Masui. 2007 Jan;56(1):9-18. Japanese.
• Erden V, Abitagaoglu S, Guler C, Dogan Z, Kirgezen S, Abut Y. Insomnia may increase anesthetic requirement. J Clin Anesth. 2016 Nov;34:367-72. doi: 10.1016/j.jclinane.2016.05.020. Epub 2016 Jun 4. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2022
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): February 10, 2023

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 14/III

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No