Clinical trial NCT05664295: Orexin-A Levels in Insomnia Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insomnia
Anesthesia
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male patients undergo elective laparoscopic cholecystectomy under general anesthesia

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.

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

Primary outcomes:
measure: Orexin-A Levels
timeFrame: at anesthesia induction, 5 minutes after extubation and 30 minutes after extubation
measure: Orexin-A Levels
timeFrame: at anesthesia induction, 5 minutes after extubation and 30 minutes after extubation
Secondary outcomes:
measure: recovery time from general anesthesia
timeFrame: time of eyes opening and time of extubation
Other outcomes:
Locations:
city: Mugla
country: Turkey
facility: Mugla Sitki Kocman University
Study officials:
affiliation: Mugla Sıtkı Kocman University Department of Anesthesiology and reanimation
name: melike Korkmaz Toker
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bollu PC, Kaur H. Sleep Medicine: Insomnia and Sleep. Mo Med. 2019 Jan-Feb;116(1):68-75.
citation: Hirota K. [Orexinergic neurons and noradrenergic awakening system in general anesthesia]. Masui. 2007 Jan;56(1):9-18. Japanese.
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.