An observational study in Postoperative Pain, Postoperative Sleep Quality and Intraoperative Dexmedetomidine, sponsored by Shengjing Hospital. Status unknown at 1 site in China. Open to participants aged 30 Years to 55 Years. Per ClinicalTrials.gov, last updated 2019-09-19.
Sponsored by Shengjing Hospital · Observational
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.
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.
This study's planned enrollment of 75 is below the median of 102 across 607 observational studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Shengjing Hospital is the lead sponsor of 124 studies on the registry; 57 are open to participants now.
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Patients who underwent elective laparoscopic abdominal surgeries under general anesthesia at Shengjing Hospital of China Medical University were enrolled in this study
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.
patients in Day group accept operation from 8：00～12：00
Other: time of receiving operation
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
Sleep quality of one night before the surgery
Use sleep monitor to test the sleep quality on one night before the surgery
Time frame: 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
Time frame: 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
Time frame: the third night after the surgery
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)
Time frame: 1,6,24,48 hours after the surgery
PCA pump press number
Evaluate the Pump press number 48 hours after the surgery
Time frame: 48 hours after the surgery
This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Shengjing Hospital