HemodynamicsNCT07290504
Gradual Versus Intermittent Release of Tourniquet Effect on MAP in Hypertensive Patients Undergoing Upper Limb Orthopedic Surgeries
A study testing Tourniquet deflation in people with Hemodynamics, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hemodynamics
- What is being tested?
- Tourniquet deflation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Dec 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient refusal
- ASA physical status > II
- Multiple orthopedic surgeries
- Emergency surgeries
- Patient with relative contraindications for tourniquet use
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo university hospitals
Cairo
Khaled Sarhan, MD, +201020067816, khaled.sarhan@kasralainy.edu.eg
About this study
Official title: 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
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.
Read the detailed description
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
- Hemodynamics
- Being tested
- Tourniquet deflation
- Keywords
- Mean arterial pressure, Acid base, Tourniquet, Orthopedics, Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tourniquet deflationDevice
Tourniquet deflation technique
| Study group | Role | What they receive |
|---|---|---|
| G group | Experimental | Gradual group (G group) deflation by rate 50mmHg/ 30s until complete release within 3 minutes Receives: 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. Receives: Device: Tourniquet deflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Arterial Pressure
The decrease in MAP (more than 25% compared to baseline) 5 minues after deflation.
Measured: 5 minutes
Secondary outcomes (3)
Acid base status
Acid base status
Measured: 5 minutes
Lactate
Lactate level
Measured: 30 minutes
Potassium level
Potassium level
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start13 Dec 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodynamicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdelfattah Abdallah Sarhan, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290504
- Sponsor's protocol ID
- N-77-2024/MSc
- Status last verified
- Aug 2026
- First submitted
- 12 Dec 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07290504
- Acronym / sponsor ID
- N-77-2024/MSc
- Conditions
- Hemodynamics
- Keywords
- Mean arterial pressure, Acid base, Tourniquet, Orthopedics, Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 13 Dec 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| G group | Experimental | Device: Tourniquet deflationGradual group (G group) deflation by rate 50mmHg/ 30s until complete release within 3 minutes |
| I group | Active comparator | Device: Tourniquet deflationIntermittent group (I group) complete deflation will occur for 10 seconds, then reinflated for 50 seconds, repeating this cycle three times until complete release. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Patient refusal
- ASA physical status > II
- Multiple orthopedic surgeries
- Emergency surgeries
- Patient with relative contraindications for tourniquet use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tourniquet deflationTourniquet deflation technique | Device | G group, I group |
Primary outcome
Mean Arterial Pressure
Time frame: 5 minutes
The decrease in MAP (more than 25% compared to baseline) 5 minues after deflation.
3 secondary outcomes
Acid base status
Time frame: 5 minutes
Lactate
Time frame: 30 minutes
Potassium level
Time frame: 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Hemodynamics
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tourniquet deflation in people with Hemodynamics, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khaled Sarhan, MD (+201020067816, khaled.sarhan@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Arterial Pressure (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.