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Dexmedetomidine on Postoperative Delirium and Quality of Recovery in Geriatric Patients

NCT01283412 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2013-11-20

No results posted yet for this study

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.

Conditions

  • Delirium, Postoperative

Interventions

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

Sponsors & Collaborators

  • Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • Yuke Tian, M.D. · Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

  • Chuanhan Zhang, MD. · Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01283412 on ClinicalTrials.gov