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Effect of Adrenaline Concentration on Intraoperative Hemodynamics of Liposuction Patients

NCT ID: NCT05822765

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-10-15

Brief Summary

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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.

Detailed Description

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Conditions

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Intraoperative Hemodynamics Liposuction

Keywords

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Adrenaline Tumescence Solution

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Epinephrine concentration of 1:1000000

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

Epinephrine concentration of 1:500000

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role collaborator

Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Neveen Abd El Maksoad Kohaf

Lecturer of Clinical Pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Neveen Kohaf

Tanta, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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RC.3.1.2023

Identifier Type: -

Identifier Source: org_study_id