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CompletedNCT05822765Updated Dec 26, 2023

Effect of Adrenaline Concentration on Intraoperative Hemodynamics of Liposuction Patients

A Phase 3 interventional study of Epinephrine concentration of 1:1000000 and Epinephrine concentration of 1:500000 in Intraoperative Hemodynamics and Liposuction, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-12-26.

Sponsored by Al-Azhar University · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Intraoperative Hemodynamics
  • Liposuction

Keywords

  • Adrenaline
  • Tumescence Solution
03

In context

Lead sponsor

Al-Azhar University is the lead sponsor of 505 studies on the registry; 167 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Bleeding disorders, anemia or hemoglobin level less than 11g/dl
  • Cardiovascular diseases,
  • Uncontrolled diabetes mellitus,
  • Collagen disorders, and
  • Pregnancy
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugEpinephrine 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

  • DrugEpinephrine 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

06

What researchers measure

Primary outcomes

  1. Blood pressure

    Noninvasive Blood pressure will be recorded

    Time frame: 4 hours

Secondary outcomes

  1. Heart rate

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

    Time frame: 4 hours

07

Study locations

1 site
  • Neveen Kohaf
    Tanta, 11865, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — data can be shared upon reasonable request from the corresponding author

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05822765
Lead sponsor
Al-Azhar University
Collaborators
Benha University
Responsible party
Neveen Abd El Maksoad Kohaf (Lecturer of Clinical Pharmacy, Al-Azhar University) — Principal investigator
First posted
Apr 21, 2023
Start date
May 1, 2023
Primary completion
Oct 15, 2023
Completion
Oct 15, 2023
Last update
Dec 26, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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