The Effect of Intraoperative Use of Dexmedetomidine During the Daytime Operation vs the Nighttime Operation on Postoperative Sleep Quality and Pain Under General Anesthesia
1 other identifier
observational
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2019
CompletedStudy Start
First participant enrolled
June 15, 2019
CompletedFirst Posted
Study publicly available on registry
June 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedSeptember 19, 2019
July 1, 2019
6 months
June 11, 2019
September 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Sleep quality of one night before the surgery
Use sleep monitor to test the sleep quality on one night before the surgery
one night before the surgery
Sleep quality of first night after the surgery
Use sleep monitor to test the sleep quality on the first night after the surgery
the first night after the surgery
Sleep quality of third night after the surgery
Use sleep monitor to test the sleep quality on the third night after the surgery
the third night after the surgery
Secondary Outcomes (2)
Visual analog scale (VAS)
1,6,24,48 hours after the surgery
PCA pump press number
48 hours after the surgery
Study Arms (2)
Day group
patients in Day group accept operation from 8：00～12：00
Night group
patients in Night group accept operation from 18：00～22：00
Interventions
patients were randomly divided into Day group (D group) (8：00～12：00) and Night group (N group) (18：00～22：00), Patients received propofol, remifentanil, and DEX for general anesthesia maintenance
Eligibility Criteria
Patients who underwent elective laparoscopic abdominal surgeries under general anesthesia at Shengjing Hospital of China Medical University were enrolled in this study
You may qualify if:
- age between 30 and 55 years American Society of Anaesthesiologists physical status I or II.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
shengjing hospital of China medical university
Shenyang, Liaoning, 110004, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Junchao Zhu
Shengjing Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
June 11, 2019
First Posted
June 19, 2019
Study Start
June 15, 2019
Primary Completion
November 30, 2019
Study Completion
December 31, 2019
Last Updated
September 19, 2019
Record last verified: 2019-07