Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00123

2 Trial Registration Date

2007-04-18

i Registration Status

Prospective

3 Secondary IDs

CUHK_CCT00123

4 Source(s) of Funding

Internal funds from Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

5 Primary Sponsor

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

6 Secondary Sponsor

Institute of Chinese Medicine, The Chinese University of Hong Kong

Function

Please specify

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

i Name

Mr Freddie Chiu

ii Address

Department of Anaesthesia and Intensive Care, The Chinese Univerisity of Hong Kong

iii Phone

Telephone: 2632 2735;

iv Email

email: freddie@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

Prof Anna Lee

ii Address

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

iii Phone

Tel: 2632 2735,

iv Email

email: annalee@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Acupressure for smoking cessation before surgery and anaesthesia

10 Public Title

Acupressure for smoking cessation before surgery and anaesthesia

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Acupressure to stop smoking

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?

2007-01-09

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

smokers undergoing elective surgery and anaesthesia

15 Intervention

i Types of intervention

Other

Please specify

acupressure + counselling

ii Description/ name of Intervention/article

Ear acupressure and counselling

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

2-3 weeks before surgery and anaesthesia

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

1. Sham ear acupressure 2. Nicotinic patches

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: current adult smokers undergoing elective surgery in 2 to 3 weeks time who are motivated to stop smoking

ii Exclusion Criteria

Exclusion: previous nicotinic replacement therapy, contraindications to nicotinic replacement therapy or ear acupuncture, history of alcohol/drug abuse, mentally incompetent, refuse to consent, patients undergoing coronary artery bypass graft surgery.

iii Age Minimum

18

iv Age Maximum

100

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

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2007-05-15

21 Target Sample Size

105

22 Recruitment Status

Unknown

23 Primary Outcome

Successful smoking cessation at the time of surgery

24 Secondary Outcome

Postoperative complications (respiratory, wound infection), quality of recovery at 72h after surgery and health related quality of life before surgery and at 72 hours after surgery.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2011-04-01

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000692

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

stopped due to recruitment difficulties

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Trial History Detail on 2011-04-01