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Effect of Adrenaline Concentration on Intraoperative Hemodynamics of Liposuction Patients

A

Al-Azhar University

Status and phase

Completed
Phase 3

Conditions

Intraoperative Hemodynamics
Liposuction

Treatments

Drug: Epinephrine concentration of 1:1000000
Drug: Epinephrine concentration of 1:500000

Study type

Interventional

Funder types

Other

Identifiers

NCT05822765
RC.3.1.2023

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

40 participants in 2 patient groups

Group A
Active Comparator group
Description:
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.
Treatment:
Drug: Epinephrine concentration of 1:1000000
Group B
Active Comparator group
Description:
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.
Treatment:
Drug: Epinephrine concentration of 1:500000

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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