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

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Quality; General Anesthesia; Circadian Rhythm Sleep Disorder; Morning Operation; Evening Operation
• Intervention / Treatment: Other: receiving operation during the day or at night

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital of China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Day group; 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; 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)
OTHER: Night group; 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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative general anesthestic requirement	record the total dose of general anesthestic requirement during the operation	during the surgery
postoperative adverse effect	record the postoperative adverse effect	24 hours after the surgery

Collaborators and Investigators

• Sponsor: Shengjing Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 20, 2019
• Primary Completion (ACTUAL): January 31, 2020
• Study Completion (ACTUAL): March 31, 2020

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (ACTUAL): September 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 21, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: general anesthesia; circadian rhythm; sleep quality; morning operation; evening operation
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Neurologic Manifestations; Occupational Diseases; Chronobiology Disorders; Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
• Other Study ID Numbers: circadian rhythm and sleep

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No