Postoperative agitation (hyperactive delirium) is common following major surgery(incidence was about 20% in our pilot study). Dexmedetomidine was related to a reduced delirium rate when comparing with midazolam in many clinical settings. It is not clear if dexmedetomidine is useful on reducing postoperative delirium. The hypothesis of present study: intraoperative application of dexmedetomidine (0.2ug/kg/h) is is effective (50% reduce) than placebo for reducing of early postoperative delirium and increase postoperative quality of recovery within 24 postoperative hours.
After approval from the Institute's Ethics Committee, this study was conducted at Tongji Hospital, a general university teaching hospital with 2500 beds in Wuhan, China.The study consisted of adult patients, American Society of Anaesthesiologists Physical Status (ASA-PS) I-III, undergoing selective major surgery under general anesthesia. All the patients were randomly assigned to receive dexmedetomidine or placebo during the operation. The primary outcome measure was postoperative delirium assessed by Nursing Delirium Screening Scale (Nu-DESC) every 8 hours within 24 postoperative hours. The secondary outcome was length of postanesthesia care unit (PACU) stay,postoperative hospital length of stay, hemodynamic parameters, the incidence of postoperative nausea and vomiting, and quality of recovery determined by quality of recovery (QOR40; maximum score 200)and Post-operative Quality Recovery Scale (PQRS) in the first 24 h after surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
500
Placebo (saline) iv. during the operation and stoped 30min before end of the surgery
Dexmedetomidine 0.1\~0.2ug/kg/h iv. during the operation, and stoped 30min before end of surgery
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGPostoperative delirium
Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours
Time frame: every 8 hours within 24 postoperative hours
Length of PACU stay
Length of PACU stay (min)
Time frame: during PACU stay
hemodynamic parameters
Heart frequency, systolic blood pressure, diastolic blood pressure
Time frame: every 5min during operation and every 15min during PACU stay
incidence of postoperative nausea and vomiting
incidence of postoperative nausea and vomiting
Time frame: 24 postoperative hours
quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS)
quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS)
Time frame: 24 postoperative hours
Postoperative delirium
Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours
Time frame: 1st, 2nd, 3rd postoperative days
Postoperative Stroke
Postoperative Stroke will be determined by National Institute of Health stroke scale (NIHSS score).
Time frame: 1st, 2nd, 3rd, 7th postoperative days
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