- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06260501
Wetting Solution-ideal Body Weight Ratio in Liposuction Procedures
The Relationship Between Postoperative Complications and Wetting Solution-ideal Body Weight Ratio in Liposuction Procedures
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey
- Acibadem Altunizade Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with American Society Of Anesthesiology physical status 1-3
- Patients who underwent high-volume liposuction with super-wet technique
Exclusion Criteria:
- Patients under 18 years of age
- Patients with a history of allergy to local anesthetic agents
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
Liposuction with super-wet technique using wetting-solution containing 0.5 gr lidocaine and 0.5 mg epinephrine in each liter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
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.
|
Duration of measurement was defined as the period immediately after surgery and up to 2 days after the end of surgery.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Serap Aktas Yildirim, M.D., Acibadem Mehmet Ali Aydinlar University School of Medicine, Department of Anesthesiology
Publications and helpful links
General 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.
- Brown 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.
- Hatef 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.
- Appelbaum 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.
- Mendez 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATADEK-2023-13/463
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | Obesity and Obesity-related Medical ConditionsUnited States
-
Central Hospital, Nancy, FranceNot yet recruiting
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | GLP-1 | Obesity and Obesity-related Medical Conditions | Ablation TechniquesUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
Clinical Trials on super-wet technique
-
Loma Linda UniversityWithdrawnStomach Neoplasms | Pancreatic Cancer
-
Hospital Universitario Insular Gran CanariaRecruiting
-
The Third Xiangya Hospital of Central South UniversityCompletedPancreatic Solid LesionsChina
-
Bin ChengUnknownInflammation | Lymphatic Metastasis | Infection | Lymphadenopathy | Pancreas Neoplasms | Neoplasm Metastases | Unknown Primary Neoplasm Metastasis | SarcoidChina
-
Sohag UniversityRecruitingEfficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet TechniqueEgypt
-
National Center for Complementary and Alternative...Completed
-
Shanghai Zhongshan HospitalUnknownNeoplasms | Lymphoma | Inflammation | Cancer | Infection | Sarcoid | Mass LesionChina
-
University of Texas at AustinUniversity of MichiganCompletedAnxiety | Depressive Symptoms | Burn Out | Posttraumatic Stress Disorder | Work Related StressUnited States
-
Karolinska InstitutetActive, not recruiting
-
Princess Nourah Bint Abdulrahman UniversityNot yet recruitingPolycystic Ovarian Syndrome (PCOS)Saudi Arabia