Gradual Versus Intermittent Release of Tourniquet Effect on MAP in Hypertensive Patients Undergoing Upper Limb Orthopedic Surgeries

NCT07290504 | Recruiting

• 1 other identifier: N-77-2024/MSc
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

In this clinical trial, the authors will compare two tourniquet deflation techniques and their clinical implications on hemodynamics and acid base parameters in hypertensive orthopedic patients undergoing upper limb surgeries under general anesthesia.

Conditions

Hemodynamics

Keywords

Mean arterial pressure; Acid base; Tourniquet; Orthopedics; Hypertension

Outcome Measures

Primary Outcomes (1)

• Mean Arterial Pressure

  The decrease in MAP (more than 25% compared to baseline) 5 minues after deflation.

  5 minutes

Secondary Outcomes (3)

• Acid base status

  5 minutes

• Lactate

  30 minutes

• Potassium level

  30 minutes

Study Arms (2)

G group

EXPERIMENTAL

Gradual group (G group) deflation by rate 50mmHg/ 30s until complete release within 3 minutes

Device: Tourniquet deflation

I group

ACTIVE COMPARATOR

Intermittent group (I group) complete deflation will occur for 10 seconds, then reinflated for 50 seconds, repeating this cycle three times until complete release.

Device: Tourniquet deflation

Interventions

Tourniquet deflation DEVICE

Tourniquet deflation technique

G group; I group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient refusal
• ASA physical status \> II
• Multiple orthopedic surgeries
• Emergency surgeries
• Patient with relative contraindications for tourniquet use

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Cairo university hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Khaled Sarhan, MD

CONTACT

+201020067816; khaled.sarhan@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: After completion of surgical procedure, tourniquet deflation will be performed by anesthesia technician into two ways according to the randomization number received in closed envelop with the patient file and blinded from the research anesthiologist: in gradual group (Ggroup) deflation by rate 50mmHg/ 30s untill complete release within 3 minutes .In intermittent group (Igroup) complete deflation will occur for 10 seconds, then reinflated for 50 seconds, repeating this cycle three times until complete release.The researcher anesthesiologist who collects data, including hemodynamics and labs will be separated from the upper limb, tourniquet device, and the technician by surgical curtain to ensure full blinding of the deflation technique.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator, Associate professor of anesthesia, Cairo university

Model Details: After completion of surgical procedure,tourniquet deflation will be performed by anesthesia technician into two ways according to the randomization number received in closed envelop with the patient file and blinded from the research anesthiologist: in gradual group (Ggroup) deflation by rate 50mmHg/ 30s untill complete release within 3 minutes .In intermittent group (Igroup) complete deflation will occur for 10 seconds, then reinflated for 50 seconds, repeating this cycle three times until complete release.

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 18, 2025
• Study Start: December 13, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)