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Completed

NCT Number: NCT05664295

Orexin-A Levels in Insomnia Patients

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.

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Key information

Conditions

Insomnia Anesthesia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

Mugla Sitki Kocman University

Muğla, 48000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Jenkins Sleep Disorders scale and Epworth Sleepiness scale

Diagnostic Test

Jenkins Sleep Disorders scale and Epworth Sleepiness scale

Primary outcomes

  1. Orexin-A Levels

    Time frame: at anesthesia induction, 5 minutes after extubation and 30 minutes after extubation

    plasma OXA levels anesthesia induction and after anesthesia in insomnia patients

  2. Orexin-A Levels

    Time frame: at anesthesia induction, 5 minutes after extubation and 30 minutes after extubation

    plasma OXA levels anesthesia induction and after anesthesia in control group

Secondary outcomes

  1. recovery time from general anesthesia

    Time frame: time of eyes opening and time of extubation

    The relationship between plasma OXA levels and recovery times from anesthesia in insomnia patients

Sponsors and collaborators

Lead sponsor

Muğla Sıtkı Koçman University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 23, 2022
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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