Carotid Doppler Peak Velocity Variation in Liposuction Fluid Management

Sponsor
TJ Plast Advanced Center for Plastic Surgery (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05930106
Collaborator
(none)
50
2
13

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Intraoperative fluid ratio
  • Device: Carotid Artery Doppler Peak Velocity Variation
N/A

Detailed Description

The research will involve 50 female participants who have undergone liposuction and will be divided into two groups.

Group 1: 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 2: Participants 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.

During the examination, a single cardiothoracic anesthesiologist will use a 13-6 MHz linear probe (Fujifilm Sonosite M-Turbo) to measure the peak velocity of the carotid artery on the left side. The sample volume will be positioned at the center of the lumen, 2 cm from the bulb, and a pulsed wave Doppler examination will be conducted.

To measure the ΔVPeak-CA, the investigators will calculate the maximum and minimum values during one respiratory cycle. This will be done by using the formula: 100x (maximum peak velocity - minimum peak velocity) / [(maximum peak velocity + minimum peak velocity)/2].

Surgical technique

The superwet tumescence technique will be the only method utilized for infiltration during the procedure. All participants will undergo power-assisted liposuction, and a single surgeon will operate. The wetting solution will contain 1000cc of normal saline and 2mg of epinephrine in a 1:500,000 ratio. The total Infiltration volume will depend on the patient.

The total amount of aspiration will depend on the patient and surgery plan and can vary between 2500 to 5000 ml

During the surgical procedure, the investigators will monitor vital signs such as blood pressure, heart rate, temperature, oxygen levels, and urine output. Additionally, the investigators will track the amount of fluids given and removed, and the volume of blood aspirated.

Following surgery, participants will be hospitalized for 24 hours. During this time, the investigators will closely monitor the plethysmography variability index (PVI) in both groups. If the PVI exceeds 15%, participants will receive a ringer lactate fluid bolus of 4-6 ml/kg. Additionally, the investigators will keep track of their urine output, total fluid intake, and vital signs

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Respiratory Variation of Carotid Doppler Peak Velocity in Liposuction Fluid Management
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group Intraoperative fluid ratio

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

Experimental: 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.

Device: Carotid Artery Doppler 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.

Outcome Measures

Primary Outcome Measures

  1. Mean Postoperative PVi [24 hours]

    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.

  2. Postoperative intravenous fluid balance [24 hours]

    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.

Secondary Outcome Measures

  1. The intraoperative total volume of urine in the patient's catheter bag [the duration of the surgery]

    During the intraoperative period, the investigators will measure and record the total volume of urine accumulated in the patient's catheter bag over the surgery period and will report urine output measured in milliliters per kilogram per hour.

  2. The postoperative total volume of urine in the patient's catheter bag [24 hours]

    During the postoperative period, the investigators will measure and record the total volume of urine accumulated in the patient's catheter bag over a 24-hour period and will report urine output measured in milliliters per kilogram per hour.

  3. Mean arterial blood pressure during hospitalization [24 hours]

    Following surgery, patients will be hospitalized for 24 hours. During this time, the investigators will monitor Mean arterial pressure

  4. The intraoperative intravenous fluid balance [the duration of the surgery]

    Throughout the surgical procedure, the investigators will meticulously monitor and record the precise amount of fluid administered in milliliters.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Female patients between 21 and 60 years old

  • Liposuction with or without abdominoplasty

  • American Society of Anesthesiologists Ӏ & ӀӀ.

Exclusion Criteria:
  • History of previous liposuction surgery

  • American Society of Anesthesiologist III

  • Coagulation disorders

  • Cardiopulmonary disorders

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • TJ Plast Advanced Center for Plastic Surgery

Investigators

  • Principal Investigator: Sergio Soto Hopkins, M.D., TJ Plast Advanced Center for Plastic Surgery
  • Study Chair: Hector Milla, M.D., TJ Plast Advanced Center for Plastic Surgery
  • Study Director: Israel Espino Gaucin, M.D., TJ Plast Advanced Center for Plastic Surgery

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Sergio Soto Hopkins, Principal Investigator, TJ Plast Advanced Center for Plastic Surgery
ClinicalTrials.gov Identifier:
NCT05930106
Other Study ID Numbers:
  • R-2023-02
First Posted:
Jul 5, 2023
Last Update Posted:
Jul 5, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sergio Soto Hopkins, Principal Investigator, TJ Plast Advanced Center for Plastic Surgery
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 5, 2023