Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00134

2 Trial Registration Date

2007-08-31

i Registration Status

Prospective

3 Secondary IDs

ENIGMA 3 study

4 Source(s) of Funding

CERG

5 Primary Sponsor

CERG

6 Secondary Sponsor

Nil

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, CUHK

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, CUHK

iii Phone

26322736

iv Email

mtvchan@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Evaluation of Nitrous Oxide In the Gas Mixture for Anesthesia Study (The ENIGMA 3 Trial)

10 Public Title

NA

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

The ENIGMA 3 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?

2006-12-05

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

Nitrous oxide

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

Oxygen

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 1. Eligible patients are men or women aged ≥18 years, 2. American Society of Anesthesiologists physical status class 1-3, 3. Patients scheduled for major elective abdominal surgeries that require resection of the gastrointestinal tract.

ii Exclusion Criteria

Exclusion 1. Acute bowel obstruction (contraindicated for N2O administration), 2. History of fever or infection ≤24 hours before surgery 3. Marked impairment of gaseous exchange (usually due to severe chronic obstructive pulmonary disease, requiring fiO2>0.4). 4. Surgery with expected duration ≤1 hour or that primary wound closure is not anticipated.

iii Age Minimum

18

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

2008-01-01

21 Target Sample Size

780

22 Recruitment Status

Complete

23 Primary Outcome

Wound infection

24 Secondary Outcome

(1) Recovery times (2) Intensive Care Unit stay (3) Death due to any cause ≤15 days of surgery.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2011-11-25

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000701

28 Date of Registration in Primary Registry

2010-05-04

Back History

Trial Detail