Orexin-A Levels in Insomnia Patients

NCT ID: NCT05664295

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-30
• Study Completion Date: 2023-02-10

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.

Conditions

Insomnia; Anesthesia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

insomnia patients

Jenkins Sleep Disorders scale skor \>1 and Epworth Sleepiness scale skor \>9

Jenkins Sleep Disorders scale and Epworth Sleepiness scale

Intervention Type: DIAGNOSTIC_TEST

Jenkins Sleep Disorders scale and Epworth Sleepiness scale

noninsomniacs

Jenkins Sleep Disorders scale skor \<2 and Epworth Sleepiness scale skor \<10

Jenkins Sleep Disorders scale and Epworth Sleepiness scale

Intervention Type: DIAGNOSTIC_TEST

Jenkins Sleep Disorders scale and Epworth Sleepiness scale

Interventions

Jenkins Sleep Disorders scale and Epworth Sleepiness scale

Jenkins Sleep Disorders scale and Epworth Sleepiness scale

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Muğla Sıtkı Koçman University

OTHER

Sponsor Role: lead

Responsible Party

Melike Korkmaz Toker

Associate Professor of Anesthesiology and Reanimation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

melike Korkmaz Toker

Role: PRINCIPAL_INVESTIGATOR

Mugla Sıtkı Kocman University Department of Anesthesiology and reanimation

Locations

Mugla Sitki Kocman University

Muğla, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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

Reference Type: BACKGROUND

PMID: 30862990 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 17243641 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27687412 (View on PubMed)

Other Identifiers

14/III

Identifier Type: -

Identifier Source: org_study_id