Effect of Adrenaline Concentration on Intraoperative Hemodynamics of Liposuction Patients

Sponsor

Al-Azhar University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05822765

Collaborator

Benha University (Other)

100

Enrollment

Location

Arms

5.5

Anticipated Duration (Months)

18.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intraoperative Hemodynamics Liposuction	Drug: Epinephrine concentration of 1:1000000 Drug: Epinephrine concentration of 1:500000	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Oct 15, 2023

Anticipated Study Completion Date :

Oct 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A 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 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
Active Comparator: Group B 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 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

Arm

Intervention/Treatment

Active Comparator: Group A

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

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

Active Comparator: Group B

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

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

Outcome Measures

Primary Outcome Measures

Blood pressure [4 hours]
Noninvasive Blood pressure will be recorded

Secondary Outcome Measures

Heart rate [4 hours]
Heart rate will be recorded every 10 minutes and results will be recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neveen Kohaf	Tanta		Egypt	11865

Sponsors and Collaborators

Al-Azhar University
Benha University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Neveen Abd El Maksoad Kohaf, Lecturer of Clinical Pharmacy, Al-Azhar University

ClinicalTrials.gov Identifier:

NCT05822765

Other Study ID Numbers:

RC.3.1.2023

First Posted:

Apr 21, 2023

Last Update Posted:

Apr 21, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Neveen Abd El Maksoad Kohaf, Lecturer of Clinical Pharmacy, Al-Azhar University

Adrenaline

Tumescence Solution

Additional relevant MeSH terms:

Epinephrine

Racepinephrine

Epinephryl borate

Study Results

No Results Posted as of Apr 21, 2023