Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00073

2 Trial Registration Date

2005-09-13

i Registration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

HHSRF

5 Primary Sponsor

HHSRF

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

Evaluation of Nitrous oxide In the Gas Mixture for Anesthesia: a randomized controlled Trial

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

The ENIGMA trial

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2003-01-16

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

Drug

Please specify

ii Description/ name of Intervention/article

Nitrous oxide

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

Nitrous oxide administration

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. Males and females, age 18 years and over 2. Planned general anesthesia for surgery that includes a skin incision and expected to exceed two hours, and the patient is expected to be in hospital for at least three days

ii Exclusion Criteria

Exclusion Criteria: 1. Endoscopic or radiological procedures 2. Cardiac surgery 3. Marked impairment of gas-exchange (requiring FiO2 > 0.3) 4. Thoracic surgery requiring one-lung ventilation (requiring FiO2 > 0.3) 5. Specific circumstances where N2O is contraindicated (eg. volvulus, pulmonary hypertension, raised intracranial pressure) 6. Lack of provision of N2O.

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

2004-01-01

21 Target Sample Size

2000

22 Recruitment Status

Complete

23 Primary Outcome

Length of hospital stay

24 Secondary Outcome

Perioperative complications Endothelial reactivity COMET assay

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2007-09-15

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

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Trial History Detail on 2009-11-19