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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01283412
• Other study ID #: TIHMZK02004
• Status: Recruiting
• Phase: Phase 3
• First received: January 24, 2011
• Last updated: November 19, 2013
• Start date: June 2013

Study information

• Verified date: November 2013
• Source: Huazhong University of Science and Technology
• Contact: Wei Mei, M.D.
• Phone: 00862783663173
• Email: wmei[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

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

Intervention

Drug:
• Placebo
Placebo (saline) iv. during the operation and stoped 30min before end of the surgery
• Dexmedetomidine
Dexmedetomidine 0.1~0.2ug/kg/h iv. during the operation, and stoped 30min before end of surgery

Locations

Country	Name	City	State
China	Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative delirium	Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours	every 8 hours within 24 postoperative hours	Yes
Secondary	Length of PACU stay	Length of PACU stay (min)	during PACU stay	No
Secondary	hemodynamic parameters	Heart frequency, systolic blood pressure, diastolic blood pressure	every 5min during operation and every 15min during PACU stay	Yes
Secondary	incidence of postoperative nausea and vomiting	incidence of postoperative nausea and vomiting	24 postoperative hours	Yes
Secondary	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	Yes
Secondary	Postoperative delirium	Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours	1st, 2nd, 3rd postoperative days	Yes
Secondary	Postoperative Stroke	Postoperative Stroke will be determined by National Institute of Health stroke scale (NIHSS score).	1st, 2nd, 3rd, 7th postoperative days	Yes