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Clinical Trials/NCT03990987
NCT03990987
Unknown
Not Applicable

The Effect of Intraoperative Use of Dexmedetomidine During the Daytime Operation vs the Nighttime Operation on Postoperative Sleep Quality and Pain Under General Anesthesia

Shengjing Hospital1 site in 1 country75 target enrollmentJune 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Shengjing Hospital
Enrollment
75
Locations
1
Primary Endpoint
Sleep quality of one night before the surgery
Last Updated
6 years ago

Overview

Brief Summary

General anesthesia is a medically induced state of low reactivity consciousness which is similar to natural sleep. 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.Clinical trials have already proved that intraoperative use of dexmedetomidine (DEX) for general anesthesia, a highly selective alpha-2 adrenergic agonist, was able to improve sedative and analgesia effects and promote sleep quality (by decreasing stage N1 sleep, increasing stage N2 sleep and sleep efficiency). However, Wenfei Tan et al reported that with the deeper sedative state provided by DEX in the daytime, the elderly male patients undergoing TURP under spinal anesthesia suffered worse sleep on the night of surgery. Thus, what the effect of intraoperative using DEX at different time periods under general anesthesia on postoperative sleep quality and pain will be needs further study.

Detailed Description

patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were enrolled. Patients were randomized to receive operation in the D group (8:00-12:00) and the N 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 PCA pump press numbers were also recorded.

Registry
clinicaltrials.gov
Start Date
June 15, 2019
End Date
December 31, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yanchao Yang

Principal investigator

Shengjing Hospital

Eligibility Criteria

Inclusion Criteria

  • age between 30 and 55 years American Society of Anaesthesiologists physical status I or II.

Exclusion Criteria

  • cardiovascular disease long term use of analgesia 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 not willing to cooperate with the experimenter.

Outcomes

Primary Outcomes

Sleep quality of one night before the surgery

Time Frame: one night before the surgery

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

Sleep quality of third night after the surgery

Time Frame: the third night after the surgery

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

Sleep quality of first night after the surgery

Time Frame: the first night after the surgery

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

Secondary Outcomes

  • Visual analog scale (VAS)(1,6,24,48 hours after the surgery)
  • PCA pump press number(48 hours after the surgery)

Study Sites (1)

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