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NCT Number: NCT04094376

Comparison of Morning Operation and Evening Operation on Postoperative Sleep Quality and Pain Under General Anesthesia

General anesthesia is a medically induced state of low reactivity consciousness involving amnesia, immobility, unconsciousness, and analgesia, which is similar to natural sleep. Its aim is to create a state of sensory deprivation to induce a lack of motor reaction to stimuli and to obtain an explicit amnesia. Some studies found that general anesthesia as an independent risk factor could result in a desynchronization of the circadian time structure and cause postoperative sleep disorders characterized by reduced rapid eye movement (REM) and slow wave sleep (SWS), which have significant deleterious impacts on postoperative outcomes, such as postoperative fatigue, severe anxiety and depression, emotional detachment and delirium, and even pain sensitivity or postoperative pain of patients.Several studies also indicated that circadian rhythms existed in human and controlled by a main internal central clock, the suprachiasmatic nuclei, located in the anterior hypothalamus, which produce and regulate biological rhythms such as sleep arousal, hormones and metabolism could also affect the dose of general anesthesics, which lead to different postoperative recoveries and may have different effects on postoperative sleep quality. Previous studies proved that postoperative sleep disturbances and poor sleep quality are associated with higher postoperative pain, changes in behavior and poor emotional well-being, which could further aggravate postoperative sleep quality. At present, there are few studies which are about the effect of circadian rhythm for different timing of surgery on intraoperative anesthestic requirement, postoperative sleep quality and pain under general anesthesia.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shengjing hospital of China Medical University

Shenyang, Liaoning, 110004, China

About this study

eighty-four patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Day Group (8:00-12:00) and the Night Group (18:00-22:00). The Portable Sleep Monitor (PSM) was performed on the following 3 nights: the night before surgery (Sleep1), the first night after surgery (Sleep 2), and the third night after surgery (Sleep 3). Postoperative pain scores using visual analogue scoring scale, subjective sleep quality using the Athens Insomnia Scale, total dose of general anesthetics and postoperative adverse effect were also recorded

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age between 18 and 65 years
  • American Society of Anaesthesiologists (ASA) physical status I or II.

Exclusion criteria

  • cardiovascular disease
  • long term use of analgesic
  • preoperative heart rate (HR) less than 50 beats/min
  • second- or third-degree atrioventricular block
  • sleep disorder
  • sleep apnea syndrome
  • history of abnormal operation or anesthesia recovery psychosis or a patient with a language communication disorder did not provide informed consent

Treatment and study plan

receiving operation during the day or at night

Other

eighty-four patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Day Group (8:00-12:00) and the Night Group (18:00-22:00)

Primary outcomes

  1. postoperative sleep quality of one night before surgery

    Time frame: one night before the surgery

    Use sleep monitor to test the sleep quality one night before surgery

  2. postoperative sleep quality of the first night after surgery

    Time frame: the first night after surgery

    Use sleep monitor to test the sleep quality the first night after surgery

  3. postoperative sleep quality of the third night after surgery

    Time frame: the third night after surgery

    Use sleep monitor to test the sleep quality the third night after surgery

Secondary outcomes

  1. intraoperative general anesthestic requirement

    Time frame: during the surgery

    record the total dose of general anesthestic requirement during the operation

  2. postoperative adverse effect

    Time frame: 24 hours after the surgery

    record the postoperative adverse effect

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Official study title

Comparison of Morning Operation and Evening Operation on Postoperative Sleep Quality and Pain Under General Anesthesia: A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 18, 2019
Registry last updated
Apr 24, 2020

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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