Gradual versus intermittent tourniquet release during upper limb surgery in people with high blood pressure
The Effect of Gradual Versus Intermittent Release of Tourniquet on Mean Arterial Blood Pressure in Hypertensive Patients Undergoing Upper Limb Orthopedic Surgeries: A Blinded Randomized Controlled Study
This trial will test whether gradual or intermittent tourniquet release better prevents sudden blood pressure and acid-base changes in people with high blood pressure having upper-limb orthopedic surgery under general anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Kasr El Aini Hospital Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07290504 on ClinicalTrials.gov |
What this trial studies
This randomized trial enrolls hypertensive patients scheduled for elective upper-limb orthopedic surgery under standardized general anesthesia. Patients are randomized to either gradual tourniquet deflation (decreasing pressure by 50 mmHg every 30 seconds until complete release within 3 minutes) or intermittent deflation (cycles of 10 seconds full deflation then 50 seconds reinflation repeated until final release). Key measurements include mean arterial pressure and arterial blood gas/acid-base parameters before and after tourniquet release, with ventilation and anesthetic management kept consistent. Deflation is performed using sealed randomization envelopes with the research anesthesiologist blinded to group assignment while an anesthesia technician carries out the allocated technique.
Who should consider this trial
Good fit: Ideal candidates are adults with well-controlled hypertension on medication for more than three months who are scheduled for elective upper-limb orthopedic surgery requiring a tourniquet for at least 30 minutes and have a BMI between 18.5 and 29.9 without significant additional surgical risks.
Not a fit: Patients with uncontrolled hypertension, ASA status above II, multiple or emergency orthopedic procedures, BMI outside the specified range, or contraindications to tourniquet use are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If one method shows fewer blood pressure swings and better acid-base stability, adopting that deflation approach could reduce perioperative cardiovascular and metabolic stress for hypertensive patients.
How similar studies have performed: Previous reports document hemodynamic and metabolic changes after tourniquet release and some have tested staged deflation methods, but direct randomized comparisons specifically in controlled hypertensive patients are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Hypertensive patients (controlled on medical treatment more than three months) * Patients scheduled for upper limb orthopedic surgeries using a tourniquet for at least 30 min. * BMI from 18.5 to 29.9 Exclusion Criteria: * Patient refusal * ASA physical status \> II * Multiple orthopedic surgeries * Emergency surgeries * Patient with relative contraindications for tourniquet use
Where this trial is running
Cairo
- Cairo university hospitals — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Khaled Sarhan, MD
- Email: khaled.sarhan@kasralainy.edu.eg
- Phone: +201020067816
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.