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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05930106
Other study ID # R-2023-02
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 20, 2023
Est. completion date December 2024

Study information

Verified date November 2023
Source TJ Plast Advanced Center for Plastic Surgery
Contact Sergio Soto Hopkins, M.D.
Phone +526621191347
Email sergio_sotohopkins@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 2024
Est. primary completion date November 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 21 Years to 60 Years
Eligibility Inclusion Criteria: - Female patients between 21 and 60 years old - Liposuction with or without abdominoplasty - American Society of Anesthesiologists ? & ??. Exclusion Criteria: - History of previous liposuction surgery - American Society of Anesthesiologist III - Coagulation disorders - Cardiopulmonary disorders

Study Design


Related Conditions & MeSH terms


Intervention

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
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 (?VPeak-CA) will be measured before, during, and after the procedure. If the ?VPeak-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 ?VPeaK-CA.

Locations

Country Name City State
Mexico TJ Plast out patient, S.A. de C.V. Tijuana Baja California

Sponsors (1)

Lead Sponsor Collaborator
TJ Plast Advanced Center for Plastic Surgery

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

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 s — View Citation

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/a — View Citation

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. Erratum In: Medicine (Baltimore). 2018 Nov;97(44):e13212. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 The intraoperative total volume of urine in the patient's catheter bag 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. the duration of the surgery
Secondary The postoperative total volume of urine in the patient's catheter bag 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. 24 hours
Secondary Mean arterial blood pressure during hospitalization Following surgery, patients will be hospitalized for 24 hours. During this time, the investigators will monitor Mean arterial pressure 24 hours
Secondary The intraoperative intravenous fluid balance Throughout the surgical procedure, the investigators will meticulously monitor and record the precise amount of fluid administered in milliliters. the duration of the surgery
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