An interventional study of Tourniquet deflation in Hemodynamics, sponsored by Kasr El Aini Hospital. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Kasr El Aini Hospital · Not applicable, Interventional, and Prevention
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.
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 68 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Kasr El Aini Hospital is the lead sponsor of 287 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Gradual group (G group) deflation by rate 50mmHg/ 30s until complete release within 3 minutes
Device: Tourniquet deflation
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
Tourniquet deflation technique
Mean Arterial Pressure
The decrease in MAP (more than 25% compared to baseline) 5 minues after deflation.
Time frame: 5 minutes
Acid base status
Acid base status
Time frame: 5 minutes
Lactate
Lactate level
Time frame: 30 minutes
Potassium level
Potassium level
Time frame: 30 minutes
Plan to share: No
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