Effect of Adrenaline Concentration on Intraoperative Hemodynamics of Liposuction Patients

NCT05822765 | Completed Phase 3

• 1 other identifier: RC.3.1.2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraoperative Hemodynamics; Liposuction

Keywords

Adrenaline; Tumescence Solution

Outcome Measures

Primary Outcomes (1)

• Blood pressure

  Noninvasive Blood pressure will be recorded

  4 hours

Secondary Outcomes (1)

• Heart rate

  4 hours

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Group B

ACTIVE COMPARATOR

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

Interventions

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

Group A

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

Group B

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I patients
• scheduled for liposuction for abdomen and flanks and body contouring with liposuction

You may not qualify if:

• Bleeding disorders, anemia or hemoglobin level less than 11g/dl
• Cardiovascular diseases,
• Uncontrolled diabetes mellitus,
• Collagen disorders, and
• Pregnancy

Sponsors & Collaborators

• Al-Azhar University: lead
• Benha University: collaborator

Study Sites (1)

Neveen Kohaf

Tanta, 11865, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: April 21, 2023
• Study Start: May 1, 2023
• Primary Completion: October 15, 2023
• Study Completion: October 15, 2023
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)