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Trial History Detail on 2011-02-08

CUHK_CCT00134

2007-08-31

Prospective

ENIGMA 3 study

CERG

CERG

Nil

Matthew Chan

Department of Anaesthesia and Intensive Care, CUHK

26322736

mtvchan@cuhk.edu.hk

The Chinese University of Hong Kong

Matthew Chan

Department of Anaesthesia and Intensive Care, CUHK

26322736

mtvchan@cuhk.edu.hk

The Chinese University of Hong Kong

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

NA

The ENIGMA 3 study

Hong Kong

Yes

2006-12-05

Anesthesia

Drug

Nitrous oxide

Intraoperative period

Oxygen

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.

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.

18

90

Both Male and Female

Interventional

Randomized

Placebo

Double-blind

Parallel

2008-01-01

780

Recruiting

Wound infection

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

No

2011-11-25

ChiCTR-TRC-09000701

2010-05-04


Yes

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