The ENIGMA-II Trial. Nitrous oxide anaesthesia and cardiac morbidity after major surgery: a randomised controlled trial - Nitrous oxide anaesthesia and cardiac morbidity after major surgery

• Conditions: The study investigates standard anaesthesia for surgery. There is no single specific 'disease' rather there is a population of patients requiring anaesthesia to permit surgery.

• Registration Number: EUCTR2009-013226-17-GB
• Lead Sponsor: Plymouth Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-11
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 7000

Inclusion Criteria

Inclusion Criteria
1. Adult males and females age = 45 years, undergoing noncardiac surgery and general anaesthesia expected to exceed two hours.
2. At increased risk of cardiac events, defined as any of
a)history of coronary artery disease as defined by a history of any one of the following:
i.angina
ii.MI
iii.segmental wall motion abnormality on echocardiography or a fixed defect on radionuclide imaging
iv.a positive exercise stress test for cardiac ischaemia
v.a positive radionuclide exercise, echocardiographic exercise, or pharmacological cardiovascular stress test for cardiac ischaemia
vi.coronary revascularization (CABG or PTCA)
vii.angiographic evidence of atherosclerotic stenosis > 50% of the diameter of any coronary artery
viii.ECG with pathological Q waves in two contiguous leads

b)heart failure
c)cerebrovascular disease thought due to atherothrombotic disease
d)aortic or peripheral vascular disease
e)or three or more of the following risk factors:
?age =70 years
?any history of congestive heart failure
?diabetes and currently on an oral hypoglycaemic agent or insulin therapy
?current treatment for hypertension
?preoperative serum creatinine >175 ?mol/L (> 2.0 mg/dl)
?current or previous high cholesterol =6.2 mmol/L (> 240 mg/dl)
?history of a transient ischemic attack (TIA) (i.e. a transient focal neurological deficit that lasted less than 24 hours and thought to be vascular in origin)
?emergency/urgent surgery (i.e. surgery which must be undertaken within 24 hours of acute presentation to hospital)
?high-risk type of surgery (i.e. intrathoracic or intraperitoneal)

Exclusion Criteria
1.having cardiac surgery
2.marked impairment of gas-exchange expected to require Fi02> 0.5 intraoperatively
3.specific circumstances where N2O is contraindicated (eg. volvulus, pulmonary hypertension, raised intracranial pressure) or the anaesthetist plans to use supplemental oxygen (eg. colorectal surgery)
4.N2O unavailable for use.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Cardiac surgery, under 45 years, nitrous oxide not clinically appropriate for type of suyrgery (EG middle ear operation etc)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified