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

Sponsor
Shengjing Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03990987
Collaborator
(none)
75
1
6.5
11.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: time of receiving operation

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
75 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
The Effect of Intraoperative Use of Dexmedetomidine During the Daytime Operation vs the Nighttime Operation on Postoperative Sleep Quality and Pain Under General Anesthesia
Actual Study Start Date :
Jun 15, 2019
Anticipated Primary Completion Date :
Nov 30, 2019
Anticipated Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Day group

patients in Day group accept operation from 8:00~12:00

Other: time of receiving operation
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

Night group

patients in Night group accept operation from 18:00~22:00

Other: time of receiving operation
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

Outcome Measures

Primary Outcome Measures

  1. Sleep quality of one night before the surgery [one night before the surgery]

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

  2. Sleep quality of first night after the surgery [the first night after the surgery]

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

  3. Sleep quality of third night after the surgery [the third night after the surgery]

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

Secondary Outcome Measures

  1. Visual analog scale (VAS) [1,6,24,48 hours after the surgery]

    Evaluate the VAS score at 1,6,24,48 hours after the surgery.Visual analog scale (VAS) score of 0 was considered painless, and a score of 10 was considered as intense pain. Scores of 4 and below were considered mild pain (pain does not affect sleep), and scores of 5 to 6 were considered moderate pain (pain influences sleep, but the patients can still fall asleep). Scores of 7 and above were considered severe pain (Due to the pain the patient is unable to sleep or wakes up)

  2. PCA pump press number [48 hours after the surgery]

    Evaluate the Pump press number 48 hours after the surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 shengjing hospital of China medical university Shenyang Liao Ning China 110004

Sponsors and Collaborators

  • Shengjing Hospital

Investigators

  • Study Director: Junchao Zhu, Shengjing Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yanchao Yang, Principal investigator, Shengjing Hospital
ClinicalTrials.gov Identifier:
NCT03990987
Other Study ID Numbers:
  • Dexmedetomidine and sleep
First Posted:
Jun 19, 2019
Last Update Posted:
Sep 19, 2019
Last Verified:
Jul 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yanchao Yang, Principal investigator, Shengjing Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 19, 2019