Remote ischaemic preconditioning to reduce myocardial complications following head and neck cancer surgery

A prospective double-blind randomised controlled trial of the impact of remote-organ ischaemic preconditioning on perioperative myocardial morbidity and postoperative complications in head and neck surgery: Myocardial Event Reduction with Ischaemic-preconditioning Therapy (MERIT)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN82938832

Enrollment

Registered

2010-07-29

Start date

2010-08-05

Completion date

Unknown

Last updated

2018-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous cell carcinoma of the upper aerodigestive tract Cancer Squamous cell carcinoma

Interventions

The intervention group will receive remote ischaemic preconditioning which will be achieved immediately after induction of anaesthesia using an orthopaedic lower limb tourniquet inflated to 50 mmHg ab

they will have a lower limb torniquet placed around their leg but this will not be inflated. The duration of treatment is 20 minutes and the follow-up is six months.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged under 90 years, either sex 2. Squamous cell carcinoma of the upper aerodigestive tract (head and neck cancer) 3. Undergoing excision of the primary site tumour and removal of cervical lymph nodes as part of the management of their condition

Exclusion criteria

Exclusion criteria: 1. Patients over 90 years of age 2. Patients unable to give informed consent 3. Patients unfit to undergo general anaesthesia 4. Patients undergoing only neck dissection surgery 5. Patients with non-squamous cell carcinoma pathology 6. Patients undergoing excision of tumours of the skull base 7. Diabetic patients taking sulphonylurea medications 8. Patients taking nicorandil 9. Patients undergoing trans-oral laser resection of tumours 10. Patients with a previous history of deep-vein thrombosis or pulmonary embolism 11. Patients with known peripheral vascular disease who have an Ankle-Brachial Pressure Index less than 0.7)

Design outcomes

Primary

Measure	Time frame
Incidence of myocardial injury following head and neck surgery, as measured by the level of cardiac troponin enzyme at days 1, 3 and 7 after the operation.	—

Secondary

Measure	Time frame
1. The rate of rise of C-reactive protein levels in the post-operative period (the inflammatory gradient) 2. Incidence and severity of post-operative complications as graded on a validated complications grading system 3. Length of stay in the Intensive Care, High-dependency and ward 4. Patient weight and swallowing status during follow-up 5. One-year MACE (Major Acute Cardiovascular Event) rate	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026