Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00141

2 Trial Registration Date

2007-09-12

iRegistration Status

Retrospective

3 Secondary IDs

CoDA Study

4 Source(s) of Funding

RGC

5 Primary Sponsor

RGC

6 Secondary Sponsor

NA

Function

Not Applicable

Please specify

7Responsible Contact Person (public contact person for patients interested in participating)

i Name

Matthew Chan

ii Address

Department of Anaesthesia and Intensive Care

iii Phone

85235052736

iv Email

mtvchan@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

China

8Research Contact Person (person to contact for scientific inquiries)

i Name

Matthew Chan

ii Address

Department of Anaesthesia and Intensive Care

iii Phone

85235052736

iv Email

mtvchan@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

China

9 Official Scientific Title of the Study

Cognitive Dysfunction after Anesthesia (CoDA) Study

10 Public Title

Cognitive Dysfunction after Anesthesia (CoDA) Study

i Public Title in Chinese 研究名稱

《BIS》監察儀對預防麻醉及手術後精神紊亂的成效

11 Short Title (Optional)

CoDA Study

12 Countries of Recruitment

Hong Kong

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2003-10-07

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CRE-2003.298

14 Medical Condition Being Studied

Anesthesia

15Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Neurophysiology guided Anaesthesia

iii Dosage form of the intervention

NA

iv Dosage of the intervention

NA

v Duration of the intervention

Intraoperative period

vi Frequency of the intervention

Intraoperative period

16Comparative Treatments

i Description/ name of comparative treatments

Routine care

ii Dosage form of the comparative treatments

NA

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

Intraoperative period

v Frequency of the comparative treatments

Intraoperative period

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion criteria: (1) Patients aged ≥ 60 years with an American Society of Anesthesiologists physical status of between 1 and 4 who have been scheduled for elective non-cardiac surgery. (2) Surgery expected to last for 2 hours or longer with an anticipated hospital stay of at least 4 days.

ii Exclusion Criteria

Exclusion criteria: (1) Patients not expected to be available for, or cooperate with, perioperative interviews. (2) Patients with major psychosis who are taking tranquillizers or antidepressants (3) Patients with disease of the central nervous system, including known or suspected dementia or memory impairment (defined as a Mini-Mental State Examination score of ≤ 23). (4) Patients with illiteracy, significant hearing or visual impairment, or language difficulties will also be excluded.

iii Age Minimum

60

iv Age Maximum

90

v Gender

Both Male and Female

18 Study Type

Interventional

19Study Design

i Randomization

Randomized

Please specify

Computer generated randomization codes

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

4

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2005-01-01

21 Target Sample Size

900

22 Recruitment Status

Complete

23 Primary Outcome

Cognitive function using neuropsychologic tests

24 Secondary Outcome

(1) Recovery time (2) Quality of recovery (3) Major perioperative complications

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2019-09-04

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000704

28 Date of Registration in Primary Registry

2010-05-04

Back History

Trial Detail