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

NCT ID: NCT07290504

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-13

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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General anesthesia will be induced using an injection of 1-1.5 mg/kg of propofol, 1-2 mic/kg of fentanyl, and 0.5 mg/kg of atracurium,with all doses to be titrated. An endotracheal tube will be inserted after 3 minutes of mask ventilation.

Anesthesia will be maintained using isoflurane (1%) and atracurium at a dosage of 0.1mg\\kg every 20 minutes.

After endotracheal intubation, the patients will be mechanically ventilated with a 50% oxygen-air mixture, utilizing a tidal volume of 8 mL/kg based on ideal body weight at an inspiratory rate of 10-14 breaths per minute. Adjustments will be made to ensure that the end-tidal CO2 partial pressure (ETCO2) between 35 and 40 mmHg, with peak airway pressure kept below 30 mmHg.

The surgeon will start limb elevation, exsanguinating of blood and applying a double- cuffed tourniquet(zimmer A.T.S.3000) at the middle of the arm over cotton padding,with pressure ranging 200 mmHg according to the patient's blood pressure (50mmHg above systolic blood pressure).

After completion of surgical procedure,tourniquet deflation will be performed by anesthesia technician blinded to the study groups 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 (G group) deflation by rate 50mmHg/ 30s untill complete release within 3 minutes .In intermittent group (I group) complete deflation will occur for 10 seconds, then reinflated for 50 seconds, repeating this cycle three times until complete release. If the surgery exceeded 2 hr, the intermittent technique for deflation will be used 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.

A bolus of lidocaine 1.5 mg\\kg will be administered 10 minutes before tourniquet inflation will be used to attenuate the increase of blood pressure after tourniquet inflation.

Conditions

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Hemodynamics

Keywords

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Mean arterial pressure Acid base Tourniquet Orthopedics Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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.

Study Groups

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G group

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

Group Type EXPERIMENTAL

Tourniquet deflation

Intervention Type DEVICE

Tourniquet deflation technique

I group

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

Group Type ACTIVE_COMPARATOR

Tourniquet deflation

Intervention Type DEVICE

Tourniquet deflation technique

Interventions

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Tourniquet deflation

Tourniquet deflation technique

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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Khaled Abdelfattah Abdallah Sarhan

principal investigator, Associate professor of anesthesia, Cairo university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo university hospitals

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Khaled Sarhan, MD

Role: CONTACT

Phone: +201020067816

Email: [email protected]

Facility Contacts

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Khaled Sarhan, MD

Role: primary

Other Identifiers

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N-77-2024/MSc

Identifier Type: -

Identifier Source: org_study_id