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

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04094376
• Other study ID #: circadian rhythm and sleep
• Status: Completed
• Phase: N/A
• Start date: September 20, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: April 2020
• Source: Shengjing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Circadian Rhythm Sleep Disorder
• Evening Operation
• General Anesthesia
• Morning Operation
• Sleep Disorders, Circadian Rhythm
• Sleep Quality
• Sleep Wake Disorders

Intervention

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)

Locations

Country	Name	City	State
China	Shengjing hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	intraoperative general anesthestic requirement	record the total dose of general anesthestic requirement during the operation	during the surgery
Secondary	postoperative adverse effect	record the postoperative adverse effect	24 hours after the surgery