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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03990987
• Other study ID #: Dexmedetomidine and sleep
• Status: Recruiting
• Start date: June 15, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2019
• Source: Shengjing Hospital
• Contact: bijia Song
• Phone: 18309845273
• Email: 630992254[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• General Anesthesia
• Intraoperative Dexmedetomidine
• Pain, Postoperative
• Postoperative Pain
• Postoperative Sleep Quality

Intervention

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

Locations

Country	Name	City	State
China	shengjing hospital of China medical university	Shenyang	Liao Ning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Visual analog scale (VAS)	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)	1,6,24,48 hours after the surgery
Secondary	PCA pump press number	Evaluate the Pump press number 48 hours after the surgery	48 hours after the surgery