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Dexmedetomidine on Postoperative Delirium and Quality of Recovery in Geriatric Patients

Primary Purpose

Delirium, Postoperative

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Placebo
Dexmedetomidine
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delirium, Postoperative focused on measuring Delirium, Dexmedetomidine, Adult Patients, Elective Major Surgery, General Anesthesia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm P

Arm D

Arm Description

Placebo infusion

Dexmedetomidine infusion

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Length of PACU stay
Length of PACU stay (min)
hemodynamic parameters
Heart frequency, systolic blood pressure, diastolic blood pressure
incidence of postoperative nausea and vomiting
incidence of postoperative nausea and vomiting
quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS)
quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS)
Postoperative delirium
Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours
Postoperative Stroke
Postoperative Stroke will be determined by National Institute of Health stroke scale (NIHSS score).

Full Information

First Posted
January 24, 2011
Last Updated
November 19, 2013
Sponsor
Huazhong University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01283412
Brief Title
Dexmedetomidine on Postoperative Delirium and Quality of Recovery in Geriatric Patients
Official Title
Intraoperative Application of Dexmedetomidine on the Incidence of Postoperative Delirium and Quality of Recovery in Geriatric Patients Undergoing Major Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Postoperative
Keywords
Delirium, Dexmedetomidine, Adult Patients, Elective Major Surgery, General Anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm P
Arm Type
Active Comparator
Arm Description
Placebo infusion
Arm Title
Arm D
Arm Type
Experimental
Arm Description
Dexmedetomidine infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (saline) iv. during the operation and stoped 30min before end of the surgery
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Dexmedetomidine 0.1~0.2ug/kg/h iv. during the operation, and stoped 30min before end of surgery
Primary Outcome Measure Information:
Title
Postoperative delirium
Description
Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours
Time Frame
every 8 hours within 24 postoperative hours
Secondary Outcome Measure Information:
Title
Length of PACU stay
Description
Length of PACU stay (min)
Time Frame
during PACU stay
Title
hemodynamic parameters
Description
Heart frequency, systolic blood pressure, diastolic blood pressure
Time Frame
every 5min during operation and every 15min during PACU stay
Title
incidence of postoperative nausea and vomiting
Description
incidence of postoperative nausea and vomiting
Time Frame
24 postoperative hours
Title
quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS)
Description
quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS)
Time Frame
24 postoperative hours
Title
Postoperative delirium
Description
Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours
Time Frame
1st, 2nd, 3rd postoperative days
Title
Postoperative Stroke
Description
Postoperative Stroke will be determined by National Institute of Health stroke scale (NIHSS score).
Time Frame
1st, 2nd, 3rd, 7th postoperative days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Mei, M.D.
Phone
00862783663173
Email
wmei@tjh.tjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yuke Tian, M.D.
Phone
00862783663173
Email
yktian@tjh.tjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuke Tian, M.D.
Organizational Affiliation
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Chuanhan Zhang, MD.
Organizational Affiliation
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Mei, M.D.
Phone
00862783663173
Email
wmei@tjh.tjmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yuke Tian, M.D.
Phone
00862783663173
Email
yktian@tjh.tjmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Wei Mei, M.D.

12. IPD Sharing Statement

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Dexmedetomidine on Postoperative Delirium and Quality of Recovery in Geriatric Patients

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