Intraoperative HemodynamicsPhase 3NCT05822765
Effect of Adrenaline Concentration on Intraoperative Hemodynamics of Liposuction Patients
A Phase 3 study testing Epinephrine concentration of 1:1000000 and Epinephrine concentration of 1:500000 in people with Intraoperative Hemodynamics and Liposuction, run by Al-Azhar University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Intraoperative Hemodynamics, Liposuction
- What is being tested?
- Epinephrine concentration of 1:1000000 and Epinephrine concentration of 1:500000
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 15 Oct 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I patients
- scheduled for liposuction for abdomen and flanks and body contouring with liposuction
Who cannot join
- Bleeding disorders, anemia or hemoglobin level less than 11g/dl
- Cardiovascular diseases,
- Uncontrolled diabetes mellitus,
- Collagen disorders, and
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Adrenaline Concentration in Tumescence Solution on Intraoperative Hemodynamics of Liposuction Patients: A Randomized Controlled Trial
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
- Being tested
- Epinephrine concentration of 1:1000000, Epinephrine concentration of 1:500000
- Keywords
- Adrenaline, Tumescence Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epinephrine concentration of 1:1000000Drug
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 1:500000Drug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Epinephrine concentration of 1:500000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Noninvasive Blood pressure will be recorded
Measured: 4 hours
Secondary outcomes (1)
Heart rate
Heart rate will be recorded every 10 minutes and results will be recorded
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 May 2023
- Primary completion15 Oct 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative HemodynamicsStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University
- Responsible party
- Principal investigator, Neveen Abd El Maksoad Kohaf, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822765
- Sponsor's protocol ID
- RC.3.1.2023
- Status last verified
- Dec 2023
- First submitted
- 10 Apr 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data can be shared upon reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adrenaline Concentration in Tumescence Solution on Intraoperative Hemodynamics of Liposuction Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05822765
- Acronym / sponsor ID
- RC.3.1.2023
- Conditions
- Intraoperative Hemodynamics, Liposuction
- Keywords
- Adrenaline, Tumescence Solution
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Collaborators
- Benha University
- Study start
- 1 May 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Epinephrine concentration of 1:1000000Tumescence 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 B | Active comparator | Drug: Epinephrine concentration of 1:500000Tumescence fluid contained Epinephrine concentration of 1:500000 two ampoule 2 mg/liter. Lidocaine 500 mg and sodium bicarbonate 8.4% 10 ml per liter. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I patients
- scheduled for liposuction for abdomen and flanks and body contouring with liposuction
Key exclusion criteria (5 listed)
- Bleeding disorders, anemia or hemoglobin level less than 11g/dl
- Cardiovascular diseases,
- Uncontrolled diabetes mellitus,
- Collagen disorders, and
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epinephrine concentration of 1:1000000Tumescence 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 | Drug | Group A |
| Epinephrine concentration of 1:500000Tumescence 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 | Drug | Group B |
Primary outcome
Blood pressure
Time frame: 4 hours
Noninvasive Blood pressure will be recorded
1 secondary outcome
Heart rate
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: Yes. data can be shared upon reasonable request from the corresponding author
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epinephrine concentration of 1:1000000 and Epinephrine concentration of 1:500000 in people with Intraoperative Hemodynamics and Liposuction, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.