LiposuctionNCT06260501
Wetting Solution-ideal Body Weight Ratio in Liposuction Procedures
An observational study of Liposuction and Obesity, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
Although the use of wetting solutions during high-volume liposuction is a standard approach, it is unclear how to optimize wetting solutions and components and their effect on postoperative complications.. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liposuction, Obesity, Postoperative Complications
- What is being tested?
- super-wet technique
- How many people
- 192 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 30 Oct 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent high-volume liposuction with super-wet technique under general anesthesia
Who may be able to join
- Patients with American Society Of Anesthesiology physical status 1-3
- Patients who underwent high-volume liposuction with super-wet technique
Who cannot join
- Patients under 18 years of age
- Patients with a history of allergy to local anesthetic agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Postoperative Complications and Wetting Solution-ideal Body Weight Ratio in Liposuction Procedures
Although the use of wetting solutions during high-volume liposuction is a standard approach, it is unclear how to optimize wetting solutions and components and their effect on postoperative complications.. Since the super-wet technique (aspiration of 1 cc per 1 cc of infiltrate) was introduced in 1986, it has become one of the most frequently applied techniques worldwide . Adrenaline and lidocaine are often added to WS due to their hemostatic and analgesic effects One of the major advantages of super-wet technique is that blood loss is quite low. However, potential cardiovascular side effects of WS and the amounts of epinephrine and lidocaine they contain, such as volume overload, local anesthetic toxicity, hypertension, arrhythmia, and tachycardia, are still a scoop of investigation. In this study, we examined the WS and the medications it contains from a different perspective to understand the possible cause of these adverse outcomes. Despite the most suitable candidates for liposuction are patients with a BMI<30 kg/m2 and low comorbidity and age, the patient group undergoing liposuction is often obese, and overweight individuals require that obesity-related pathophysiological changes be taken into consideration. Therefore, we analyzed the patients by dividing them into two groups according to the amount of WS applied according to their IBW (WS/IBW≤90ml/kg: group I and WS/IBW>90ml/kg: group I). In this study we aimed to evaluate the effect of wetting solutions and components calculated according to ideal body weight (IBW) on postoperative complications
Read the detailed description
Liposuction is one of the most popular aesthetic surgical procedures worldwide making it possible to remove a significant amount of adipose tissue. Generally, liposuction is seen as a benign minor operation, but it can be considered a major surgery due to risk factors such as long operation times, intraoperative volume shifts, hypothermia, usage of high-dose adrenaline and lidocaine in wetting solution (WS), and possibly cardiac or pulmonary fatal complications. Therefore, anesthesiologists and plastic surgeons need to be aware of the intraoperative and postoperative pathophysiological changes caused by liposuction. In the literature, large-volume liposuction is defined as the removal of more than 5 liters of lipoaspirate in a single procedure.
The most suitable candidates for liposuction are individuals with BMI<30 kg/m2, but large-volume liposuction is applied more frequently to overweight and obese individuals. However, obesity can cause pathophysiological changes. In particular, increased cardiac output and changes in distribution volume may affect the pharmacokinetics and pharmacodynamics of drugs. Medications administered according to actual body weight (ABW) may lead to adverse outcomes due to overdose. For this reason, some approaches recommend adjusting perioperative medications according to IBW instead of ABW. The effects of WS and its components used in liposuction on patient outcomes have been examined in many studies, but the IBWs of the patients have not been taken into consideration. This study aimed to examine the effect of WSs calculated according to the IBW on postoperative complications and adverse events.
- Conditions
- Liposuction, Obesity, Postoperative Complications
- Being tested
- super-wet technique
- Keywords
- Liposuction, Obesity, Ideal body weight, Wetting solution, Epinephrine, Lidocaine
- Medical subject headings
- Obesity, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
super-wet techniqueOther
Liposuction with super-wet technique using wetting-solution containing 0.5 gr lidocaine and 0.5 mg epinephrine in each liter
| Study group | Role | What they receive |
|---|---|---|
| High volume liposuction under general anesthesia with super-wet technique | Patients who underwent high-volume liposuction with super-wet technique using wetting-solution containing 0.5 gr lidocaine and 0.5 mg epinephrine in each liter under general anesthesia Receives: Other: super-wet technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial pressure (MAP) was measured to detect hypertension and hypotension.
MAP is a parameter used to evaluate blood pressure. If the MAP value was above 90 mm/hg, it was considered hypertension. If the MAP value was above 60 mm/hg, it was considered hypotension
Measured: Duration of measurement was defined as one minute before anesthesia induction, during the surgery, and up to 2 days after surgery.
The Numerical Pain Rating Scale (NRS) was used to assess postoperative pain level
The Numerical Pain Rating Scale measures pain levels using a numerical scale from 0 to 10. 10 indicates the maximum value, and 0 indicates the minimum value. Values above 4 indicate a worse outcome, and values below 4 indicate a better outcome.
Measured: Duration of measurement was defined as the period immediately after surgery and up to 2 days after the end of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Sep 2021
- Primary completion30 Sep 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for LiposuctionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serap Aktas Yildirim, M.D., Principal investigator, Acibadem Mehmet Ali Aydinlar University School of Medicine, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260501
- Sponsor's protocol ID
- ATADEK-2023-13/463
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Obara S, Yoshida K, Inoue S. How obesity affects the disposition of intravenous anesthetics. Curr Opin Anaesthesiol. 2023 Aug 1;36(4):414-421. doi: 10.1097/ACO.0000000000001280. Epub 2023 Jun 8.
PubMed 37314170Brown SA, Lipschitz AH, Kenkel JM, Sorokin E, Shepherd G, Grebe S, Oliver LK, Luby M, Rohrich RJ. Pharmacokinetics and safety of epinephrine use in liposuction. Plast Reconstr Surg. 2004 Sep 1;114(3):756-63; discussion 764-5. doi: 10.1097/01.prs.0000131021.17800.be.
PubMed 15318058Hatef DA, Brown SA, Lipschitz AH, Kenkel JM. Efficacy of lidocaine for pain control in subcutaneous infiltration during liposuction. Aesthet Surg J. 2009 Mar-Apr;29(2):122-8. doi: 10.1016/j.asj.2009.01.014.
PubMed 19371843Appelbaum N, Clarke J. Ideal body weight calculations: fit for purpose in modern anaesthesia? Eur J Anaesthesiol. 2021 Dec 1;38(12):1211-1214. doi: 10.1097/EJA.0000000000001515. No abstract available.
PubMed 33876785Mendez BM, Coleman JE, Kenkel JM. Optimizing Patient Outcomes and Safety With Liposuction. Aesthet Surg J. 2019 Jan 1;39(1):66-82. doi: 10.1093/asj/sjy151.
PubMed 29947738
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Postoperative Complications and Wetting Solution-ideal Body Weight Ratio in Liposuction Procedures
- ClinicalTrials.gov ID
- NCT06260501
- Acronym / sponsor ID
- ATADEK-2023-13/463
- Conditions
- Liposuction, Obesity, Postoperative Complications
- Keywords
- Liposuction, Obesity, Ideal body weight, Wetting solution, Epinephrine, Lidocaine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 15 Feb 2024 (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.
Although the use of wetting solutions during high-volume liposuction is a standard approach, it is unclear how to optimize wetting solutions and components and their effect on postoperative complications.. Since the super-wet technique (aspiration of 1 cc per 1 cc of infiltrate) was introduced in 1986, it has become one of the most frequently applied techniques worldwide . Adrenaline and lidocaine are often added to WS due to their hemostatic and analgesic effects One of the major advantages of super-wet technique is that blood loss is quite low. However, potential cardiovascular side effects of WS and the amounts of epinephrine and lidocaine they contain, such as volume overload, local anesthetic toxicity, hypertension, arrhythmia, and tachycardia, are still a scoop of investigation. In this study, we examined the WS and the medications it contains from a different perspective to understand the possible cause of these adverse outcomes. Despite the most suitable candidates for liposuction are patients with a BMI<30 kg/m2 and low comorbidity and age, the patient group undergoing liposuction is often obese, and overweight individuals require that obesity-related pathophysiological changes be taken into consideration. Therefore, we analyzed the patients by dividing them into two groups according to the amount of WS applied according to their IBW (WS/IBW≤90ml/kg: group I and WS/IBW>90ml/kg: group I). In this study we aimed to evaluate the effect of wetting solutions and components calculated according to ideal body weight (IBW) on postoperative complications
Detailed description
Liposuction is one of the most popular aesthetic surgical procedures worldwide making it possible to remove a significant amount of adipose tissue. Generally, liposuction is seen as a benign minor operation, but it can be considered a major surgery due to risk factors such as long operation times, intraoperative volume shifts, hypothermia, usage of high-dose adrenaline and lidocaine in wetting solution (WS), and possibly cardiac or pulmonary fatal complications. Therefore, anesthesiologists and plastic surgeons need to be aware of the intraoperative and postoperative pathophysiological changes caused by liposuction. In the literature, large-volume liposuction is defined as the removal of more than 5 liters of lipoaspirate in a single procedure.
The most suitable candidates for liposuction are individuals with BMI<30 kg/m2, but large-volume liposuction is applied more frequently to overweight and obese individuals. However, obesity can cause pathophysiological changes. In particular, increased cardiac output and changes in distribution volume may affect the pharmacokinetics and pharmacodynamics of drugs. Medications administered according to actual body weight (ABW) may lead to adverse outcomes due to overdose. For this reason, some approaches recommend adjusting perioperative medications according to IBW instead of ABW. The effects of WS and its components used in liposuction on patient outcomes have been examined in many studies, but the IBWs of the patients have not been taken into consideration. This study aimed to examine the effect of WSs calculated according to the IBW on postoperative complications and adverse events.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High volume liposuction under general anesthesia with super-wet technique | – | Other: super-wet techniquePatients who underwent high-volume liposuction with super-wet technique using wetting-solution containing 0.5 gr lidocaine and 0.5 mg epinephrine in each liter under general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent high-volume liposuction with super-wet technique under general anesthesia
Key inclusion criteria (2 listed)
- Patients with American Society Of Anesthesiology physical status 1-3
- Patients who underwent high-volume liposuction with super-wet technique
Key exclusion criteria (2 listed)
- Patients under 18 years of age
- Patients with a history of allergy to local anesthetic agents
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 |
|---|---|---|
| super-wet techniqueLiposuction with super-wet technique using wetting-solution containing 0.5 gr lidocaine and 0.5 mg epinephrine in each liter | Other | High volume liposuction under general anesthesia with super-wet technique |
Primary outcome
Mean arterial pressure (MAP) was measured to detect hypertension and hypotension.
Time frame: Duration of measurement was defined as one minute before anesthesia induction, during the surgery, and up to 2 days after surgery.
MAP is a parameter used to evaluate blood pressure. If the MAP value was above 90 mm/hg, it was considered hypertension. If the MAP value was above 60 mm/hg, it was considered hypotension
The Numerical Pain Rating Scale (NRS) was used to assess postoperative pain level
Time frame: Duration of measurement was defined as the period immediately after surgery and up to 2 days after the end of surgery.
The Numerical Pain Rating Scale measures pain levels using a numerical scale from 0 to 10. 10 indicates the maximum value, and 0 indicates the minimum value. Values above 4 indicate a worse outcome, and values below 4 indicate a better outcome.
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 15 Feb 2024.
- Background: PubMed 37314170Obara S, Yoshida K, Inoue S. How obesity affects the disposition of intravenous anesthetics. Curr Opin Anaesthesiol. 2023 Aug 1;36(4):414-421. doi: 10.1097/ACO.0000000000001280. Epub 2023 Jun 8.
- Background: PubMed 15318058Brown SA, Lipschitz AH, Kenkel JM, Sorokin E, Shepherd G, Grebe S, Oliver LK, Luby M, Rohrich RJ. Pharmacokinetics and safety of epinephrine use in liposuction. Plast Reconstr Surg. 2004 Sep 1;114(3):756-63; discussion 764-5. doi: 10.1097/01.prs.0000131021.17800.be.
- Background: PubMed 19371843Hatef DA, Brown SA, Lipschitz AH, Kenkel JM. Efficacy of lidocaine for pain control in subcutaneous infiltration during liposuction. Aesthet Surg J. 2009 Mar-Apr;29(2):122-8. doi: 10.1016/j.asj.2009.01.014.
- Background: PubMed 33876785Appelbaum N, Clarke J. Ideal body weight calculations: fit for purpose in modern anaesthesia? Eur J Anaesthesiol. 2021 Dec 1;38(12):1211-1214. doi: 10.1097/EJA.0000000000001515. No abstract available.
- Results publication: PubMed 29947738Mendez BM, Coleman JE, Kenkel JM. Optimizing Patient Outcomes and Safety With Liposuction. Aesthet Surg J. 2019 Jan 1;39(1):66-82. doi: 10.1093/asj/sjy151.
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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.
Serap Aktas Yildirim, M.D. principal investigator
Acibadem Mehmet Ali Aydinlar University School of Medicine, Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liposuction and Obesity, run by Acibadem University at 1 site in Turkey (Türkiye).
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 2 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 15 Feb 2024. 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 Turkey (Türkiye). 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.
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?
Mean arterial pressure (MAP) was measured to detect hypertension and hypotension. (time frame: Duration of measurement was defined as one minute before anesthesia induction, during the surgery, and up to 2 days after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06260501, which also lists 5 linked publications.
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 15 Feb 2024; AzTrials last refreshed its copy on 31 Oct 2026.