Carotid Doppler Peak Velocity Variation in Liposuction Fluid Management

NCT05930106 | Completed DMC

• 1 other identifier: R-2023-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the hemodynamic parameters, postoperative plethysmography variability index, the total amount of postoperative intravenous fluid administration needed, and the urine output of two methods of fluid resuscitation during liposuction surgery. One method involves using carotid artery Doppler peak velocity variation, while the other is the conventional fluid ratio.

Conditions

Lipodystrophy

Keywords

liposuction; carotid artery doppler peak velocity variation; plethysmography variability index; fluid ratio

Outcome Measures

Primary Outcomes (2)

• Mean Postoperative PVi

  Following surgery, patients will be hospitalized for 24 hours. Throughout this period, the investigators will keep a close eye on the Plethysmography Variability Index (PVi) in both groups. The PVi is a dynamic index that measures the relative variability of the plethysmography waveform detected noninvasively from a pulse oximetry sensor, ranging from 0 to 100. By automatically calculating the dynamic changes that occur during the respiratory cycle, it uses the detected amplitudes. A higher variability in the plethysmography waveform has been linked to preload dependence and fluid responders. If the PVi exceeds 15%, the patient will receive a fluid bolus of lactated ringer solution at a rate of 4-6 ml/kg over 10-15 minutes.

  24 hours

• Postoperative intravenous fluid balance

  Following surgery, patients will be hospitalized for 24 hours. During the postoperative period, the investigators will keep track and document the exact volume of fluid administered in milliliters.

  24 hours

Secondary Outcomes (4)

• The intraoperative total volume of urine in the patient's catheter bag

  the duration of the surgery

• The postoperative total volume of urine in the patient's catheter bag

  24 hours

• Mean arterial blood pressure during hospitalization

  24 hours

• The intraoperative intravenous fluid balance

  the duration of the surgery

Study Arms (2)

Group Intraoperative fluid ratio

ACTIVE COMPARATOR

The intraoperative fluid ratio will determine fluid administration. This ratio is calculated by dividing the sum of subcutaneous infiltration and intravenous fluid by the total aspirate volume. Depending on the aspiration volume, it will be maintained at 1-1.4.

Other: Intraoperative fluid ratio

Group Carotid Artery Peak Velocity Variation

EXPERIMENTAL

Patients will be given a fluid maintenance rate of 1.5 ml/kg/h. To determine fluid responsiveness, the carotid artery peak velocity variation (ΔVPeak-CA) will be measured before, during, and after the procedure. If the ΔVPeak-CA goes above 15%, the patient will receive a fluid bolus of lactated ringer solution at a rate of 4-6 ml/kg over 10-15 minutes, and the team will re-measure fluid responsiveness 10 minutes after each ΔVPeaK-CA.

Device: Carotid Artery Doppler Peak Velocity Variation

Interventions

Intraoperative fluid ratio OTHER

This ratio is calculated by dividing the sum of procedure subcutaneous infiltration and intravenous fluid by the total aspirate volume during surgery

Group Intraoperative fluid ratio

Carotid Artery Doppler Peak Velocity Variation DEVICE

Patients will be given a fluid maintenance rate of 1.5 ml/kg/h. To determine fluid responsiveness, the carotid artery peak velocity variation (ΔVPeak-CA) will be measured before, during, and after the procedure. If the ΔVPeak-CA goes above 15%, the patient will receive a fluid bolus of lactated ringer solution at a rate of 4-6 ml/kg over 10-15 minutes, and the team will re-measure fluid responsiveness 10 minutes after each ΔVPeaK-CA.

Group Carotid Artery Peak Velocity Variation

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients between 21 and 60 years old
• Liposuction with or without abdominoplasty
• American Society of Anesthesiologists Ӏ \& ӀӀ.

You may not qualify if:

• History of previous liposuction surgery
• American Society of Anesthesiologist III
• Coagulation disorders
• Cardiopulmonary disorders

Sponsors & Collaborators

• TJ Plast Advanced Center for Plastic Surgery: lead

Study Sites (1)

TJ Plast out patient, S.A. de C.V.

Tijuana, Estado de Baja California, 9288, Mexico

Location

Related Publications (3)

• Wang G, Cao WG, Zhao TL. Fluid management in extensive liposuction: A retrospective review of 83 consecutive patients. Medicine (Baltimore). 2018 Oct;97(41):e12655. doi: 10.1097/MD.0000000000012655.

  PMID: 30313055 BACKGROUND

• Song Y, Kwak YL, Song JW, Kim YJ, Shim JK. Respirophasic carotid artery peak velocity variation as a predictor of fluid responsiveness in mechanically ventilated patients with coronary artery disease. Br J Anaesth. 2014 Jul;113(1):61-6. doi: 10.1093/bja/aeu057. Epub 2014 Apr 9.

  PMID: 24722322 RESULT

• Ibarra-Estrada MA, Lopez-Pulgarin JA, Mijangos-Mendez JC, Diaz-Gomez JL, Aguirre-Avalos G. Respiratory variation in carotid peak systolic velocity predicts volume responsiveness in mechanically ventilated patients with septic shock: a prospective cohort study. Crit Ultrasound J. 2015 Dec;7(1):29. doi: 10.1186/s13089-015-0029-1. Epub 2015 Jun 26.

  PMID: 26123610 RESULT

MeSH Terms

Conditions

Lipodystrophy

Condition Hierarchy (Ancestors)

Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Sergio Soto Hopkins, M.D.

  TJ Plast Advanced Center for Plastic Surgery

  PRINCIPAL INVESTIGATOR

• Hector Milla, M.D.

  TJ Plast Advanced Center for Plastic Surgery

  STUDY CHAIR

• Israel Espino Gaucin, M.D.

  TJ Plast Advanced Center for Plastic Surgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The research will involve 50 female patients who have undergone liposuction and will be divided into two groups. Group Intraoperative Fluid Ratio: Fluid administration will be determined by the intraoperative fluid ratio. This ratio is calculated by dividing the sum of subcutaneous infiltration and intravenous fluid by the total aspirate volume. Depending on the aspiration volume, it will be maintained at 1-1.4. Group Carotid Artery Peak Velocity Variation: Patients will be given a fluid maintenance rate of 1.5 ml/kg/h. To determine fluid responsiveness, the carotid artery peak velocity variation (ΔVPeak-CA) will be measured before, during, and after the procedure. If the ΔVPeak-CA goes above 15%, the patient will receive a fluid bolus of lactated ringer solution at a rate of 4-6 ml/kg over 10-15 minutes, and the team will re-measure fluid responsiveness 10 minutes after each ΔVPeaK-CA.

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: July 5, 2023
• Study Start: November 20, 2023
• Primary Completion: November 20, 2024
• Study Completion: December 20, 2024
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2 months after publication and for 24 months
• Access Criteria: Qualified researchers can request access to IPD, and will be provided following the review and approval of the research proposal

Locations

ME (1)