NCT06260501

Brief 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.. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 15, 2024

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

2.1 years

First QC Date

February 5, 2024

Last Update Submit

February 14, 2024

Conditions

Keywords

LiposuctionObesityIdeal body weightWetting solutionEpinephrineLidocaine

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    Duration of measurement was defined as the period immediately after surgery and up to 2 days after the end of surgery.

Study Arms (1)

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

Other: super-wet technique

Interventions

Liposuction with super-wet technique using wetting-solution containing 0.5 gr lidocaine and 0.5 mg epinephrine in each liter

High volume liposuction under general anesthesia with super-wet technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent high-volume liposuction with super-wet technique under general anesthesia

You may qualify if:

  • Patients with American Society Of Anesthesiology physical status 1-3
  • Patients who underwent high-volume liposuction with super-wet technique

You may not qualify if:

  • Patients under 18 years of age
  • Patients with a history of allergy to local anesthetic agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem Altunizade Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 37314170BACKGROUND
  • 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.

    PMID: 15318058BACKGROUND
  • 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.

    PMID: 19371843BACKGROUND
  • 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.

    PMID: 33876785BACKGROUND
  • 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.

MeSH Terms

Conditions

ObesityPostoperative Complications

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Serap Aktas Yildirim, M.D.

    Acibadem Mehmet Ali Aydinlar University School of Medicine, Department of Anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2024

First Posted

February 15, 2024

Study Start

September 1, 2021

Primary Completion

September 30, 2023

Study Completion

October 30, 2023

Last Updated

February 15, 2024

Record last verified: 2024-02

Locations