Dexmedetomidine on Postoperative Delirium and Quality of Recovery in Geriatric Patients

Phase 3

• Conditions: Delirium, Postoperative
• Interventions: Drug: Placebo; Drug: Dexmedetomidine

• Registration Number: NCT01283412
• Lead Sponsor: Huazhong University of Science and Technology

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.

Study Timeline

• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-01-24
• Study First Posted: 2011-01-26
• Study Start: 2013-06
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-19
• Last Update Posted: 2013-11-20
• Primary Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm P	Placebo	Placebo infusion
Arm D	Dexmedetomidine	Dexmedetomidine infusion

Primary Outcome Measures

Name	Time	Method
Postoperative delirium	every 8 hours within 24 postoperative hours	Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours

Secondary Outcome Measures

Name	Time	Method
quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS)	24 postoperative hours	quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS)
Postoperative Stroke	1st, 2nd, 3rd, 7th postoperative days	Postoperative Stroke will be determined by National Institute of Health stroke scale (NIHSS score).
Length of PACU stay	during PACU stay	Length of PACU stay (min)
hemodynamic parameters	every 5min during operation and every 15min during PACU stay	Heart frequency, systolic blood pressure, diastolic blood pressure
Postoperative delirium	1st, 2nd, 3rd postoperative days	Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours
incidence of postoperative nausea and vomiting	24 postoperative hours	incidence of postoperative nausea and vomiting

Trial Locations

Locations (1)

Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China