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Dexmedetomidine on Postoperative Delirium and Quality of Recovery

This study is currently recruiting participants.
Verified October 2012 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: October 9, 2012
Last verified: October 2012
History of Changes
  Purpose

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 (0.1~0.2ug/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 Intervention Phase
Delirium, Postoperative
 Drug: Placebo
Drug: Dexmedetomidine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraoperative Application of Dexmedetomidine on the Incidence of Postoperative Delirium and Quality of Recovery in Adult Patients Undergoing Major Surgery

Resource links provided by NLM:

MedlinePlus related topics: Delirium
U.S. FDA Resources

Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 380
Study Start Date: January 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 Nu-DESC and CAM-ICU every 8 hours within 24 postoperative hours. The secondary outcome was length of PACU stay,postoperative hospital length of stay, hemodynamic parameters, the incidence of postoperative nausea and vomiting, and quality of recovery determined by QOR40 and PQRS in the first 24 h after surgery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA physical status class I-III
  • Aged 18 years or above
  • Elective major surgery under general anesthesia

Exclusion Criteria:

  • ASA-PS>=IV
  • Aged under 18 yr old
  • Body mass index (BMI) >30
  • Neurologic disease
  • Anticonvulsant drugs
  • Chronic analgesics intake
  • Participating in the investigation of another study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283412

Contacts
Contact: Wei Mei, M.D. 00862783663173 wmei@tjh.tjmu.edu.cn
Contact: Yuke Tian, M.D. 00862783663173 yktian@tjh.tjmu.edu.cn

Locations
China, Hubei
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Wei Mei, M.D.     00862783663173     wmei@tjh.tjmu.edu.cn    
Contact: Yuke Tian, M.D.     00862783663173     yktian@tjh.tjmu.edu.cn    
Principal Investigator: Wei Mei, M.D.            
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
  More Information

No publications provided

Responsible Party: Wei Mei, Associate Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01283412     History of Changes
Other Study ID Numbers: TIHMZK02004
Study First Received: January 24, 2011
Last Updated: October 9, 2012
Health Authority: China: Ministry of Health

Keywords provided by Huazhong University of Science and Technology:
Delirium
Dexmedetomidine
Adult Patients
Elective Major Surgery
General Anesthesia

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013