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.
Conditions
Interventions
Product Name: nitrous oxide
Pharmaceutical Form: Inhalation gas
INN or Proposed INN: nitrous oxide
Concentration unit: % percent
Concentration type: up to
Concentration number: 70-
Trade Name: air
Pr
Sponsors
Plymouth Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Cardiac surgery, under 45 years, nitrous oxide not clinically appropriate for type of suyrgery (EG middle ear operation etc)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Are patients who receive nitrous oxide as a part of their anaesthetic more likely die or to experience cardiovascular events? The primary endpoint is a composite of death and cardiovascular events (clinical and silent MI, cardiac arrest, pulmonary embolism, and stroke) measured at 30 days after surgery.;Secondary Objective: Are any of the following secondary endpoints in creased amongst patients receiving nitrous oxide? 1. Myocardial Infarction (MI) 2. Cardiac arrest 3. Pulmonary embolism 4. Stroke 5. Wound infection 6. Severe PONV 7. ICU Stay 8. Hospital Stay ;Primary end point(s): Primary Endpoint The primary endpoint is a composite of death and cardiovascular events (clinical and silent MI, cardiac arrest, pulmonary embolism, and stroke) measured at 30 days after surgery. | — |
Countries
United Kingdom
Outcome results
None listed