Orexin-A Levels in Insomnia Patients

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05664295
• Other study ID #: 14/III
• Status: Completed
• Start date: December 30, 2022
• Est. completion date: February 10, 2023

Study information

• Verified date: March 2023
• Source: Mugla Sitki Koçman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 10, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Diagnostic Test:
• Jenkins Sleep Disorders scale and Epworth Sleepiness scale
Jenkins Sleep Disorders scale and Epworth Sleepiness scale

Locations

Country	Name	City	State
Turkey	Mugla Sitki Kocman University	Mugla

Sponsors (1)

Lead Sponsor	Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Bollu PC, Kaur H. Sleep Medicine: Insomnia and Sleep. Mo Med. 2019 Jan-Feb;116(1):68-75. — View Citation

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. — View Citation

Hirota K. [Orexinergic neurons and noradrenergic awakening system in general anesthesia]. Masui. 2007 Jan;56(1):9-18. Japanese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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