Clinical trial NCT05930106: Carotid Doppler Peak Velocity Variation in Liposuction Fluid Management
Official title: Respiratory Variation of Carotid Doppler Peak Velocity in Liposuction Fluid Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipodystrophy
Keywords: liposuction
carotid artery doppler peak velocity variation
plethysmography variability index
fluid ratio
Lead sponsor: TJ Plast Advanced Center for Plastic Surgery
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Mean Postoperative PVi
timeFrame: 24 hours
measure: Postoperative intravenous fluid balance
timeFrame: 24 hours
Secondary outcomes:
measure: The intraoperative total volume of urine in the patient's catheter bag
timeFrame: the duration of the surgery
measure: The postoperative total volume of urine in the patient's catheter bag
timeFrame: 24 hours
measure: Mean arterial blood pressure during hospitalization
timeFrame: 24 hours
measure: The intraoperative intravenous fluid balance
timeFrame: the duration of the surgery
Other outcomes:
Locations:
city: Tijuana
country: Mexico
facility: TJ Plast out patient, S.A. de C.V.
state: Baja California
Study officials:
affiliation: TJ Plast Advanced Center for Plastic Surgery
name: Sergio Soto Hopkins, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: TJ Plast Advanced Center for Plastic Surgery
name: Hector Milla, M.D.
role: STUDY_CHAIR
affiliation: TJ Plast Advanced Center for Plastic Surgery
name: Israel Espino Gaucin, M.D.
role: STUDY_DIRECTOR
References:
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.
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/aeu057. Epub 2014 Apr 9.
citation: 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.