Orexin-A Levels in Insomnia Patients

Completed

• Conditions: Anesthesia; Insomnia
• Interventions: Diagnostic Test: Jenkins Sleep Disorders scale and Epworth Sleepiness scale

• Registration Number: NCT05664295
• Lead Sponsor: Muğla Sıtkı Koçman University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-12-16
• Study First Posted: 2022-12-23
• Study Start: 2022-12-30
• Primary Completion: 2023-01-30
• Study Completion: 2023-02-10
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
insomnia patients	Jenkins Sleep Disorders scale and Epworth Sleepiness scale	Jenkins Sleep Disorders scale skor \>1 and Epworth Sleepiness scale skor \>9
noninsomniacs	Jenkins Sleep Disorders scale and Epworth Sleepiness scale	Jenkins Sleep Disorders scale skor \<2 and Epworth Sleepiness scale skor \<10

Primary Outcome Measures

Name	Time	Method
Orexin-A Levels	at anesthesia induction, 5 minutes after extubation and 30 minutes after extubation	plasma OXA levels anesthesia induction and after anesthesia in control group

Secondary Outcome Measures

Name	Time	Method
recovery time from general anesthesia	time of eyes opening and time of extubation	The relationship between plasma OXA levels and recovery times from anesthesia in insomnia patients

Trial Locations

Locations (1)

Mugla Sitki Kocman University; 🇹🇷 Mugla, Turkey