Dexmedetomidine on Postoperative Delirium and Quality of Recovery in Geriatric Patients

Sponsor

Huazhong University of Science and Technology (Other)

Overall Status

Unknown status

CT.gov ID

NCT01283412

Collaborator

(none)

500

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Delirium, Postoperative	Drug: Placebo Drug: Dexmedetomidine	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2013

Anticipated Primary Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm P Placebo infusion	Drug: Placebo Placebo (saline) iv. during the operation and stoped 30min before end of the surgery
Experimental: Arm D Dexmedetomidine infusion	Drug: Dexmedetomidine Dexmedetomidine 0.1~0.2ug/kg/h iv. during the operation, and stoped 30min before end of surgery

Arm

Intervention/Treatment

Active Comparator: Arm P

Placebo infusion

Drug: Placebo

Placebo (saline) iv. during the operation and stoped 30min before end of the surgery

Experimental: Arm D

Dexmedetomidine infusion

Drug: Dexmedetomidine

Dexmedetomidine 0.1~0.2ug/kg/h iv. during the operation, and stoped 30min before end of surgery

Outcome Measures

Primary Outcome Measures

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

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
incidence of postoperative nausea and vomiting [24 postoperative hours]
incidence of postoperative nausea and vomiting
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 delirium [1st, 2nd, 3rd postoperative days]
Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours
Postoperative Stroke [1st, 2nd, 3rd, 7th postoperative days]
Postoperative Stroke will be determined by National Institute of Health stroke scale (NIHSS score).

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China	430030

Sponsors and Collaborators

Huazhong University of Science and Technology

Investigators

Study Chair: Yuke Tian, M.D., Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Study Director: Chuanhan Zhang, MD., Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology