Clinical trial NCT01283412: Dexmedetomidine on Postoperative Delirium and Quality of Recovery in Geriatric Patients
Official title: Intraoperative Application of Dexmedetomidine on the Incidence of Postoperative Delirium and Quality of Recovery in Geriatric Patients Undergoing Major Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Delirium, Postoperative
Keywords: Delirium
Dexmedetomidine
Adult Patients
Elective Major Surgery
General Anesthesia
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2011-01-26
Enrollment: 500
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* ASA physical status class I-III
* Aged 60 years or above
* Elective major surgery under general anesthesia

Exclusion Criteria:

* ASA-PS\>=IV
* Aged under 60 yr old
* Body mass index (BMI) \>30
* Neurologic disease
* Cardiac surgery and neurologic surgery
* Anticonvulsant drugs
* Chronic analgesics intake
* Participating in the investigation of another study

Primary outcomes:
measure: Postoperative delirium
timeFrame: every 8 hours within 24 postoperative hours
Secondary outcomes:
measure: Length of PACU stay
timeFrame: during PACU stay
measure: hemodynamic parameters
timeFrame: every 5min during operation and every 15min during PACU stay
measure: incidence of postoperative nausea and vomiting
timeFrame: 24 postoperative hours
measure: quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS)
timeFrame: 24 postoperative hours
measure: Postoperative delirium
timeFrame: 1st, 2nd, 3rd postoperative days
measure: Postoperative Stroke
timeFrame: 1st, 2nd, 3rd, 7th postoperative days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Yuke Tian, M.D.
role: STUDY_CHAIR
affiliation: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Chuanhan Zhang, MD.
role: STUDY_DIRECTOR
References: