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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04094376
Other study ID # circadian rhythm and sleep
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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