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) Ó€& Ó€Ó€.
- 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