Intraoperative Fluid Management of Liposuction , Cardiometry Versus Rohrich Formula

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Brief Title

Intraoperative Fluid Management of Liposuction , Cardiometry Versus Rohrich Formula

Official Title

Intraoperative Fluid Management of Large Volume Liposuction Surgery , Cardiometry Guided Stroke Volume Variation Versus Rohrich Formula

Brief Summary

      The aim of the study is to compare the hemodynamic parameters of fluid resuscitation using
      Rohrich formula to cardiometry guided stroke volume variation in patients undergoing large
      volume liposuction surgery .
    

Detailed Description

      The study will done on 50 patients divided equally into two groups. Group A Fluid
      administration in the form of lactated ringer will be managed by Rohrich formula and the
      intraoperative fluid ratio (subcutaneous infiltration fluid plus intravenous fluid divided by
      total aspirate volume) will be 1.2. Rohrich formula represents fluid maintenance,deficit and
      replacement fluid ( 0.25 ml crystalloid given for each 1 ml above 4 litre of lipoaspirate).

      Group B Patients will receive fluid maintenance of lactated ringer 2 ml/kg/h, cardiometry
      guided stroke volume variation will be measured before and after induction then every 30 min
      ,it ranges between 5-15%, fluid bolus of lactated ringer 4 ml /kg over 15 min will be
      administered if stroke volume variation ˃ 15% .

      Electrical cardiometry will be connected to the patient before induction,the skin will be
      clean and dry before placing the electrodes. Four electrodes will be applied, first one is at
      the upper part of the anterior aspect of the neck, second one is 5 cm below the first
      electrode at lower part of the neck, third one at the lower left thorax in line with xiphoid
      process at the level of anterior axillary line and the fourth one is 5 cm below the third
      electrode at the level of anterior axillary line.Electrical cardiometry will be connected to
      the sensor cable and the patient data will be applied as (gender - age - height - weight -
      blood pressure -heart rate - hemoglobin and oxygen saturation).

      Surgical Technique The wetting solution will be lactated ringer with epinephrine 1mg on 1
      litre so concentration is 1:1,000,000.10 ml lidocaine 2% will be added.Subcutaneous
      infiltration of the wetting solution will facillate dissection and removal of fat ,the
      technique that will be used is traditional liposuction , suction assisted liposuction with
      super wet technique ( the amount of infiltration solution is equal to the amount of fat
      aspirate).

      The liposuction cannula is a multihole blunt tip cannula with a diameter of 3 to 6 mm, 4-6 mm
      for deep liposuction,2-4 mm for superficial liposuction and a length ranging between 10 to 30
      cm. The surgeon will inject the wetting solution to the target area until it becomes tense
      then infiltrates the other side waiting 10 to 15 min after infiltration to begin suction .The
      aspirate will be collected in suction container, fat will separate from solution after
      approximately 1-2 h by gravity into upper yellowish part includes fat called supernatant and
      lower part includes blood tinged fluid called infranatant.

      Measurements

        -  Noninvasive blood pressure ,oxygen saturation, Heart rate before induction, 5 min and 15
           min after induction then every 30 min.

        -  Urine output, baseline and every hour.

        -  Venous blood sample for measurement of hemoglobin and hematocrit level after aspiration
           of 4 litre of fat and for every litre after.

        -  Measurement of blood volume in aspirate by taking a sample from infranatant part after
           its separation from fat for hemoglobin level calculation and by equation of multiplying
           this hemoglobin concentration to infranatant volume divided by preoperative hemoglobin
           concentration, the investigators can measure blood volume in aspirate .

        -  Amount of intravenous and infiltration fluids.

        -  Amount of fat and total aspirate.

        -  Stroke volume variation before and after induction then every 30 min.
    


Study Type

Interventional


Primary Outcome

Mean arterial blood pressure

Secondary Outcome

 blood loss

Condition

Lipodystrophy

Intervention

Electrical Cardiometry (EC) ICON

Study Arms / Comparison Groups

 GROUP A
Description:  Fluid administration in the form of lactated ringer will be managed by Rohrich formula and the intraoperative fluid ratio (subcutaneous infiltration fluid plus intravenous fluid divided by total aspirate volume) will be 1.2(10). Rohrich formula represents fluid maintinance,deficit and replacement fluid ( 0.25 ml crystalloid given for each 1 ml above 4 litre of lipoaspirate).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

50

Start Date

June 2022

Completion Date

July 2023

Primary Completion Date

June 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Male and female patients aged between 21 to 60 years.

          -  American Society of Anesthesiologists (ASA) Ӏ& ӀӀ.

          -  Large volume liposuction.

        Exclusion Criteria:

          -  Any bleeding& coagulation disorders.

          -  Patients on regular anticoagulant or antiplatelet drugs.

          -  History of previous surgery in treated areas.

          -  Significant cardiopulmonary, hepatic or renal disease.
      

Gender

All

Ages

21 Years - 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Ahmed Abdel Wahed Ali, physician, +20 01065043864, [email protected]

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations


NCT ID

NCT05402982

Organization ID

fluid status of liposuction


Responsible Party

Sponsor-Investigator

Study Sponsor

Ahmed Abdel Wahed Ali

Collaborators

 Tanta University

Study Sponsor

Ahmed Abdel Wahed Ali, physician, Principal Investigator, Tanta University


Verification Date

May 2022