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

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain; General Anesthesia; Postoperative Sleep Quality; Intraoperative Dexmedetomidine
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 75

Contacts and Locations

Study Locations

• China
  • Liao Ning
    • Shenyang, Liao Ning, China, 110004
      • Recruiting
      • Shengjing Hospital of China Medical University
      • Contact: Zhu junchao, doctor; Phone Number: 18940257257; Email: zhujunchao1@hotmail.com
      • Contact: Song bijia, master; Phone Number: 18309845273; Email: 630992254@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent elective laparoscopic abdominal surgeries under general anesthesia at Shengjing Hospital of China Medical University were enrolled in this study

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
PCA pump press number	Evaluate the Pump press number 48 hours after the surgery	48 hours after the surgery

Collaborators and Investigators

• Sponsor: Shengjing Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2019
• Primary Completion (ANTICIPATED): November 30, 2019
• Study Completion (ANTICIPATED): December 31, 2019

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 16, 2019
• First Posted (ACTUAL): June 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: general anesthesia; dexmedetomidine; postoperative pain; postoperative sleep quality
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: Dexmedetomidine and sleep

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No