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

NCT04094376 | Completed

• 1 other identifier: circadian rhythm and sleep
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Morning Operation; Evening Operation; Sleep Quality; General Anesthesia; Circadian Rhythm Sleep Disorder

Keywords

morning operation; evening operation; sleep quality; general anesthesia; circadian rhythm

Outcome Measures

Primary Outcomes (3)

• postoperative sleep quality of one night before surgery

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

  one night before the surgery

• postoperative sleep quality of the first night after surgery

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

  the first night after surgery

• postoperative sleep quality of the third night after surgery

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

  the third night after surgery

Secondary Outcomes (2)

• intraoperative general anesthestic requirement

  during the surgery

• postoperative adverse effect

  24 hours after the surgery

Study Arms (2)

Day group

OTHER

42 patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Day Group (8:00-12:00)

Other: receiving operation during the day or at night

Night group

OTHER

42 patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Night Group (18:00-22:00)

Other: receiving operation during the day or at night

Interventions

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)

Day group; Night group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Chronobiology Disorders; Occupational Diseases

Study Officials

• Junchao Zhu

  Shengjing Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 18, 2019
• Study Start: September 20, 2019
• Primary Completion: January 31, 2020
• Study Completion: March 31, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

CN (1)