Effect of Adrenaline Concentration on Intraoperative Hemodynamics of Liposuction Patients

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Liposuction, Intraoperative Hemodynamics

Intervention / Treatment
-----------------
* Drug: Epinephrine concentration of 1:1000000
* Drug: Epinephrine concentration of 1:500000


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Tumescence fluid contained Epinephrine concentration of 1:1000000 (one ampoule 1 mg per liter) Llidocaine 500 mg and sodium bicarbonate 8.4% 10 ml per liter. | Drug: Epinephrine concentration of 1:1000000<br>* 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<br>|
| Active Comparator: Group B<br>Tumescence fluid contained Epinephrine concentration of 1:500000 two ampoule 2 mg/liter. Lidocaine 500 mg and sodium bicarbonate 8.4% 10 ml per liter. | Drug: Epinephrine concentration of 1:500000<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Noninvasive Blood pressure will be recorded | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Heart rate will be recorded every 10 minutes and results will be recorded | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adrenaline, Tumescence Solution