Clinical trial

Effect of Adrenaline Concentration in Tumescence Solution on Intraoperative Hemodynamics of Liposuction Patients: A Randomized Controlled Trial

Name
RC.3.1.2023
Description
Liposuction is a procedure that has emerged over the last 30 years as a method to remove subcutaneous fat for cosmetic purposes. Numerous liposuction techniques have been developed .Tumescent liposuction involves using large volumes of dilute local anesthetic and epinephrine to facilitate anesthesia and decrease blood loss. Questions remain about the appropriate dose of local anesthetic, the use of general anesthesia in liposuction, and the setting in which the chosen liposuction method is used. Adrenaline is the most commonly used vasoconstrictor, the recommended concentration in the tumescent solution is 0.25-1 mg/L depending on the tissue vascularity. In the more vascular tissues, the concentration is 1 mg/L and is decreased to 0.5 mg/L in the less vascular areas of the body. The dose should not exceed 50μg/kg. If the maximum dose is anticipated to exceed, the procedure should be done in several stages.
Trial arms
Trial start
2023-05-01
Estimated PCD
2023-10-15
Trial end
2023-10-15
Status
Completed
Phase
Early phase I
Treatment
Epinephrine concentration of 1:1000000
Tumescence fluid contained Epinephrine concentration of 1:1000000 (one ampoule 1 mg per liter) lidocaine 500 mg and sodium bicarbonate 8.4% 10 ml per liter
Arms:
Group A
Epinephrine concentration of 1:500000
Tumescence fluid contained Epinephrine concentration of 1:500000 two ampoule 2 mg/liter with same lidocaine and bicarbonate dose. lidocaine 500 mg and sodium bicarbonate 8.4% 10 ml per liter
Arms:
Group B
Size
40
Primary endpoint
Blood pressure
4 hours
Eligibility criteria
Inclusion Criteria: * ASA I patients * scheduled for liposuction for abdomen and flanks and body contouring with liposuction Exclusion Criteria: * Bleeding disorders, anemia or hemoglobin level less than 11g/dl * Cardiovascular diseases, * Uncontrolled diabetes mellitus, * Collagen disorders, and * Pregnancy
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}
Updated at
2023-12-26

1 organization

1 product

2 indications

Indication
Liposuction