An interventional study of Intraoperative fluid ratio and Carotid Artery Doppler Peak Velocity Variation in Lipodystrophy, sponsored by TJ Plast Advanced Center for Plastic Surgery. Completed at 1 site in Mexico. Open to female participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-23.
Sponsored by TJ Plast Advanced Center for Plastic Surgery · Not applicable, Interventional, and Treatment
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.
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
139 studies on the registry are indexed under Lipodystrophy; 10 are open to participants now.
This study's enrollment of 50 is close to the median of 46 across 97 interventional studies indexed under Lipodystrophy.
Browse Lipodystrophy studies →This is the only study on the registry with TJ Plast Advanced Center for Plastic Surgery as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
This ratio is calculated by dividing the sum of procedure subcutaneous infiltration and intravenous fluid by the total aspirate volume during surgery
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.
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.
Time frame: 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.
Time frame: 24 hours
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.
Time frame: the duration of the surgery
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.
Time frame: 24 hours
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
Time frame: 24 hours
The intraoperative intravenous fluid balance
Throughout the surgical procedure, the investigators will meticulously monitor and record the precise amount of fluid administered in milliliters.
Time frame: the duration of the surgery
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Data obtained through this study may be provided to qualified researchers interested in liposuction fluid management. Data will be coded, and approval consent forms it's a prerequisite.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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
Ran from Nov 2023 to primary completion in Nov 2024, 12 months.
Of 23 interventional studies with no phase under Lipodystrophy, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 23. This study's 12 months is close to that.
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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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