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Completed

NCT Number: NCT05822765

Effect of Adrenaline Concentration on Intraoperative Hemodynamics of Liposuction Patients

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.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Neveen Kohaf

Tanta, 11865, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epinephrine concentration of 1:1000000

Drug

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

Epinephrine concentration of 1:500000

Drug

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

Primary outcomes

  1. Blood pressure

    Time frame: 4 hours

    Noninvasive Blood pressure will be recorded

Secondary outcomes

  1. Heart rate

    Time frame: 4 hours

    Heart rate will be recorded every 10 minutes and results will be recorded

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Collaborators

  • Benha University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2023
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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