Clinical trial NCT04055779: Minimal Inflation Tourniquet Pressure Using Induced Hypotension
Official title: Minimal Inflation Tourniquet Pressure Using Induced Hypotension With Limb Occlusion Pressure Determination or Arterial Occlusion Pressure Estimation in Upper Limb Surgery: A Randomized Double Blinded Comparative Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vascular Diseases
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include the patients scheduled for elective upper limb surgery under general anesthesia who met the inclusion criteria The patient will be scheduled into either group A or B.

Group (A): The patients will receive induced hypotensive anaesthesia and the tourniquet pressure will be based on the AOP .

Group (B): the patients will receive induced hypotensive anaesthesia and tourniquet pressure will be based on LOP.

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Brief summary: Limb occlusion pressure (LOP) and arterial occlusion pressure (AOP) are the terms that mean the lowest tourniquet pressure required to stop the arterial blood flow into the limb distal to the cuff. LOP can be determined manually or automatically by slow cuff inflation until disapper of pulsation with Doppler flow-meter or pulse oximeter

Detailed description: The advantages of the tourniquet during upper or lower limb procedures are providing bloodless operative field and so less intra-operative blood lossIt has been reported that using the lowest effective inflation pressure minimize tourniquet induced nerve injury .). Limb occlusion pressure (LOP) and arterial occlusion pressure (AOP) are the terms that mean the lowest tourniquet pressure required to stop the arterial blood flow into the limb distal to the cuff. LOP can be determined manually or automatically by slow cuff inflation until disapper of pulsation with Doppler flowmeter or pulse oximeter .AOP can be estimated by a formula (AOP = \[SBP + 10\]/KTP) using patient's systolic blood pressure (SBP) and tissue padding coefficient (KTP) values. In both methods, addition of a safety margin to LOP or AOP is recommended for potential hemodynamic fluctuations during surgery

Eligibility criteria: Inclusion Criteria:

* • ASA physical status I and II.

  * Male and female patient
  * Age group 20-50 years old

Exclusion Criteria:

* • Patient who refuse to participate in the study

  * Patients with contraindication of using the tourniquet (e.g. peripheral vascular disease or coronary artery disease sickle cell anemia neuromuscular disorders,)
  * Contraindications of using induced hypotensive anesthesia (cerebrovascular disease, Impaired kidney function , chronic liver disease, pregnancy).
  * Patients on medications inﬂuencing blood ﬂow such as nitrogycerine
  * Surgery extends more than 90 minutes.
  * Hypertensive patients

Primary outcomes:
measure: Tourniquet inflation pressure
timeFrame: tourniquet inflation pressures will be recorded at 0, 5, 15, 30, 60, and 120 min.
measure: time required to set the tourniquet inflation pressures
timeFrame: one minute before inflation of the tourniquet cuff
Secondary outcomes:
measure: tourniquet performance
timeFrame: at the middle and end of surgery
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-Suef University Hospital
Study officials:
affiliation: Assisstant proffesor of anesthesia
name: Samaa ak Rashwan, MD
role: PRINCIPAL_INVESTIGATOR
References: