Dexmedetomidine on Postoperative Delirium and Quality of Recovery in Geriatric Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Huazhong University of Science and Technology
Sponsor:
Information provided by (Responsible Party):
Wei Mei, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01283412
First received: January 24, 2011
Last updated: November 19, 2013
Last verified: November 2013

January 24, 2011
November 19, 2013
June 2013
June 2014   (final data collection date for primary outcome measure)
Postoperative delirium [ Time Frame: every 8 hours within 24 postoperative hours ] [ Designated as safety issue: Yes ]
Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours
Postoperative delirium [ Time Frame: every 8 hours within 24 postoperative hours ] [ Designated as safety issue: Yes ]
Postoperative delirium was determined by Nu-DESC and CAM-ICU every 8 hours within 24 postoperative hours
Complete list of historical versions of study NCT01283412 on ClinicalTrials.gov Archive Site
  • Length of PACU stay [ Time Frame: during PACU stay ] [ Designated as safety issue: No ]
    Length of PACU stay (min)
  • hemodynamic parameters [ Time Frame: every 5min during operation and every 15min during PACU stay ] [ Designated as safety issue: Yes ]
    Heart frequency, systolic blood pressure, diastolic blood pressure
  • incidence of postoperative nausea and vomiting [ Time Frame: 24 postoperative hours ] [ Designated as safety issue: Yes ]
    incidence of postoperative nausea and vomiting
  • quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS) [ Time Frame: 24 postoperative hours ] [ Designated as safety issue: Yes ]
    quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS)
  • Postoperative delirium [ Time Frame: 1st, 2nd, 3rd postoperative days ] [ Designated as safety issue: Yes ]
    Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours
  • Postoperative Stroke [ Time Frame: 1st, 2nd, 3rd, 7th postoperative days ] [ Designated as safety issue: Yes ]
    Postoperative Stroke will be determined by National Institute of Health stroke scale (NIHSS score).
  • Length of PACU stay [ Time Frame: during PACU stay ] [ Designated as safety issue: No ]
    Length of PACU stay (min)
  • hemodynamic parameters [ Time Frame: every 5min during operation and every 15min during PACU stay ] [ Designated as safety issue: Yes ]
    HF, systolic blood preasure, diastolic blood preasure
  • incidence of postoperative nausea and vomi [ Time Frame: 24 postoperative hours ] [ Designated as safety issue: Yes ]
    incidence of postoperative nausea and vomiting
  • quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS) [ Time Frame: 24 postoperative hours ] [ Designated as safety issue: Yes ]
    quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS)
Not Provided
Not Provided
 
Dexmedetomidine on Postoperative Delirium and Quality of Recovery in Geriatric Patients
Intraoperative Application of Dexmedetomidine on the Incidence of Postoperative Delirium and Quality of Recovery in Geriatric Patients Undergoing Major Surgery

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Delirium, Postoperative
  • Drug: Placebo
    Placebo (saline) iv. during the operation and stoped 30min before end of the surgery
  • Drug: Dexmedetomidine
    Dexmedetomidine 0.1~0.2ug/kg/h iv. during the operation, and stoped 30min before end of surgery
  • Active Comparator: Arm P
    Placebo infusion
    Intervention: Drug: Placebo
  • Experimental: Arm D
    Dexmedetomidine infusion
    Intervention: Drug: Dexmedetomidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
Not Provided
June 2014   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact: Wei Mei, M.D. 00862783663173 wmei@tjh.tjmu.edu.cn
Contact: Yuke Tian, M.D. 00862783663173 yktian@tjh.tjmu.edu.cn
China
 
NCT01283412
TIHMZK02004
Yes
Wei Mei, Huazhong University of Science and Technology
Huazhong University of Science and Technology
Not Provided
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
Huazhong University of Science and Technology
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP