Dexmedetomidine on Postoperative Delirium and Quality of Recovery in Geriatric Patients

Study Overview
=================
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.

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

Conditions
-----------------
Delirium, Postoperative

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Dexmedetomidine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative delirium | Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours | every 8 hours within 24 postoperative hours | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Delirium, Dexmedetomidine, Adult Patients, Elective Major Surgery, General Anesthesia