Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00072

2 Trial Registration Date

2005-09-13

i Registration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

RGC, CERG

5 Primary Sponsor

RGC, CERG

6 Secondary Sponsor

Function

Please specify

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

i Name

Matthew Chan

ii Address

Dept Anaesthesia and Intensive Care, CUHK

iii Phone

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

Dept Anaesthesia and Intensive Care, CUHK

iii Phone

iv Email

mtvchan@cuhk.edu.hk

v Affiliation

vi Country

9 Official Scientific Title of the Study

A Randomized Controlled Trial of Auditory Evoked Potential Monitoring to Improve Recovery from General Anesthesia

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

The A-Line trial

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2001-10-10

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Quality of recovery

15 Intervention

i Types of intervention

Other

Please specify

Depth of anesthesia monitoring

ii Description/ name of Intervention/article

Auditory evoked potential

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Intraoperative peroid

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 Men or women, age > 18 years, American Society of Anesthesiologists physical status 1 to 3, scheduled for elective surgery expected to last at least 1 hour will be recruited.

ii Exclusion Criteria

Exclusion criteria Patients will be excluded if they are not expected to be available for, or to cooperate with, interview postoperatively. These are patients scheduled for ambulatory, cardiac or neurosurgical procedures. Patients will also be excluded if they require postoperative ventilation or if they have major psychosis, language difficulties, known or suspected dementia or memory impairment. Other exclusion criteria are patients known to be allergic to propofol or sevoflurane or who has significant hearing abnormalities or if the attending anesthetists or patient preferred an alternative anesthetic technique. Reasons for exclusion will be documented.

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

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

2002-12-01

21 Target Sample Size

1060

22 Recruitment Status

Complete

23 Primary Outcome

Quality of recovery

24 Secondary Outcome

perioperative complications

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2007-09-17

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000657

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

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Trial History Detail on 2012-08-31