NCT01283412

Brief 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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2011

Completed
2.3 years until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Last Updated

November 20, 2013

Status Verified

November 1, 2013

Enrollment Period

1 year

First QC Date

January 24, 2011

Last Update Submit

November 19, 2013

Conditions

Delirium, Postoperative

Keywords

DeliriumDexmedetomidineAdult PatientsElective Major SurgeryGeneral Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative delirium

    Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours

    every 8 hours within 24 postoperative hours

Secondary Outcomes (6)

  • Length of PACU stay

    during PACU stay

  • hemodynamic parameters

    every 5min during operation and every 15min during PACU stay

  • incidence of postoperative nausea and vomiting

    24 postoperative hours

  • quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS)

    24 postoperative hours

  • Postoperative delirium

    1st, 2nd, 3rd postoperative days

  • +1 more secondary outcomes

Study Arms (2)

Arm P

ACTIVE COMPARATOR

Placebo infusion

Drug: Placebo

Arm D

EXPERIMENTAL

Dexmedetomidine infusion

Drug: Dexmedetomidine

Interventions

PlaceboDRUG

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

Arm P
DexmedetomidineDRUG

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

Arm D

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status class I-III
  • Aged 60 years or above
  • Elective major surgery under general anesthesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Emergence DeliriumDelirium

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Yuke Tian, M.D.

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

    STUDY CHAIR

  • Chuanhan Zhang, MD.

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

    STUDY DIRECTOR

Central Study Contacts

Wei Mei, M.D.

CONTACT

00862783663173wmei@tjh.tjmu.edu.cn

Yuke Tian, M.D.

CONTACT

00862783663173yktian@tjh.tjmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 24, 2011

First Posted

January 26, 2011

Study Start

June 1, 2013

Primary Completion

June 1, 2014

Last Updated

November 20, 2013

Record last verified: 2013-11

Locations

CN(1)