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Dexmedetomidine on Postoperative Delirium and Quality of Recovery in Geriatric Patients

NCT ID: NCT01283412

Last Updated: 2013-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Delirium, Postoperative

Keywords

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Delirium Dexmedetomidine Adult Patients Elective Major Surgery General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm P

Placebo infusion

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

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

Arm D

Dexmedetomidine infusion

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

Interventions

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Placebo

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

Intervention Type DRUG

Dexmedetomidine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Wei Mei

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuke Tian, M.D.

Role: STUDY_CHAIR

Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Chuanhan Zhang, MD.

Role: STUDY_DIRECTOR

Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Locations

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Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Mei, M.D.

Role: CONTACT

Phone: 00862783663173

Email: [email protected]

Yuke Tian, M.D.

Role: CONTACT

Phone: 00862783663173

Email: [email protected]

Facility Contacts

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Wei Mei, M.D.

Role: primary

Yuke Tian, M.D.

Role: backup

Other Identifiers

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TIHMZK02004

Identifier Type: -

Identifier Source: org_study_id