Dexmedetomidine on Postoperative Delirium and Quality of Recovery in Geriatric Patients

Delirium, Postoperative Clinical Trial

Official title: Intraoperative Application of Dexmedetomidine on the Incidence of Postoperative Delirium and Quality of Recovery in Geriatric Patients Undergoing Major Surgery

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Delirium
• Delirium, Postoperative

• NCT number: NCT01283412
• Study type: Interventional
• Source: Huazhong University of Science and Technology
• Contact: Wei Mei, M.D.
• Phone: 00862783663173
• Email: wmei@tjh.tjmu.edu.cn
• Status: Recruiting
• Phase: Phase 3
• Start date: June 2013