Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00107

2 Trial Registration Date

2006-03-17

i Registration Status

Prospective

3 Secondary IDs

4 Source(s) of Funding

Departmental

5 Primary Sponsor

Departmental

6 Secondary Sponsor

Function

Please specify

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

i Name

Matthew Chan

ii Address

iii Phone

Department ofAnaesthesia and Intensive Care

iv Email

mtvchan@cuhk.edu.hk

v Affiliation

vi Country

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

i Name

Matthew Chan

ii Address

iii Phone

Department ofAnaesthesia and Intensive Care

iv Email

mtvchan@cuhk.edu.hk

v Affiliation

vi Country

9 Official Scientific Title of the Study

Delirium and Cognitive Decline After Surgery: Anesthetic Management to Improve Postoperative Mental Health Outcome

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2006-03-07

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Delirium and cognitive dysfunction

15 Intervention

i Types of intervention

Other

Please specify

Neurophysiologic monitoring

ii Description/ name of Intervention/article

Neurophysiologic monitoring (Bispectral index)

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 anesthetic 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

Eligible patients are elderly (>/= 65 years) men or women aged scheduled for elective major colorectal surgery, that are expected to last for 2 hours or longer Exclusion criteria: (1) Patients not expected to be cooperate with perioperative interviews. (2) Patients with major psychosis (3) Patients with known or suspected dementia or memory impairment (4) Patients with illiteracy, significant hearing or visual impairment, or language difficulties.

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Open label

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

2006-10-01

21 Target Sample Size

500

22 Recruitment Status

Recruiting

23 Primary Outcome

Confusion assessment method, cognitive failure questionnaire

24 Secondary Outcome

(1) Recovery times (2) Quality of recovery (3) Perioperative complications

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-11-27

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

None

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Trial History Detail on 2007-09-15