Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00141

2 Trial Registration Date

2007-09-12

i Registration Status

Retrospective

3 Secondary IDs

CoDA Study

4 Source(s) of Funding

RGC

5 Primary Sponsor

RGC

6 Secondary Sponsor

NA

Function

Please specify

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

i Name

Matthew Chan

ii Address

Department of Anaesthesia and Intensive Care

iii Phone

26322736

iv Email

mtvchan@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

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

i Name

Matthew Chan

ii Address

Department of Anaesthesia and Intensive Care

iii Phone

2632 2736

iv Email

mtvchan@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

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

11 Short Title (Optional)

CoDA Study

12 Countries of Recruitment

Hong Kong

13 Research 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

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Anesthesia

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Neurophysiology guided Anaesthesia

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Intraoperative period

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Routine care

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key 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

19 Study Design

i Randomization

Randomized

Please specify

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

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2005-01-01

21 Target Sample Size

1,000

22 Recruitment Status

Recruiting

23 Primary Outcome

Cognitive function using neuropsychologic tests

24 Secondary Outcome

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

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last 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

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

NA

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Trial History Detail on 2011-02-08