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CTRI Number  CTRI/2024/11/076581 [Registered on: 11/11/2024] Trial Registered Prospectively
Last Modified On: 07/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   How Two Different Fluids Affect Blood Flow Before Spinal Anesthesia: A Comparison of Ringers Lactate and Sterofundin 
Scientific Title of Study   Effect of Preloading on Inferior Vena Cava Collapsibility Index: A Comparative Observational Study of Ringers Lactate versus Sterofundin 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deep Pareshkumar Unadkat 
Designation  Resident doctor ( M.D. Anaesthesiology) 
Affiliation  GMERS, medical college and hospital, Gotri, Vadodara 
Address  6th floor, department of anaesthesiology, GMERS hospital, Gotri, Vadodadra

Vadodara
GUJARAT
390021
India 
Phone  8200279749  
Fax    
Email  drdeepunadkat@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anup Chandnani 
Designation  Professor and head ( M.D. Anaesthesiology) 
Affiliation  GMERS, medical college and hospital, Gotri, Vadodara 
Address  6th floor, department of anaesthesiology, GMERS hospital, Gotri, Vadodadra

Vadodara
GUJARAT
390021
India 
Phone  9925436505  
Fax    
Email  anupchandnani29@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Deep Pareshkumar Unadkat 
Designation  Resident doctor ( M.D. Anaesthesiology) 
Affiliation  GMERS, medical college and hospital, Gotri, Vadodara 
Address  6th floor, department of anaesthesiology, GMERS hospital, Gotri, Vadodadra

Vadodara
GUJARAT
390021
India 
Phone  8200279749  
Fax    
Email  drdeepunadkat@gmail.com  
 
Source of Monetary or Material Support    
Primary Sponsor  
Name  GMERS hospital Gotri Vadodara  
Address  GMERS medical college and hospital, Gotri, Vadodara,390021,Gujarat, India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deep Unadkat  GMERS hospital  6th floor, department of anaesthesiology, GMERS hospital, Gotri, Vadodadra
Vadodara
GUJARAT 		 8200279749

drdeepunadkat@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IHEC GMERS medical college and hospital, Gotri  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: V279||Unspecified motorcycle rider injured in collision with fixed or stationary object in traffic accident,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ringer lactate  Sodium: 130 mEq/L Chloride: 109 mEq/L Potassium: 4 mEq/L Calcium: 2.7 mEq/L Lactate: 28 mEq/L (acts as a buffer) Approximate Osmolarity: 273 mOsm/L Typical pH Range: 6.0–7.5 
Intervention  Sterofundin  Sodium: 145 mEq/L Chloride: 127 mEq/L Potassium: 4 mEq/L Calcium: 2.5 mEq/L Magnesium: 1 mEq/L Acetate: 24 mEq/L Malate: 5 mEq/L Approximate Osmolarity: 309 mOsm/L Typical pH Range: 5.1–5.9 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients posted for lower limb orthopaedic surgery under spinal anaesthesia in supine position.

patients with American society of anaesthesia physical status I and II

Patients listed for elective surgery.

Fasting for more than 8 hours.
 
 
ExclusionCriteria 
Details  patients with American society of anaesthesia physical status III and more.
Pregnant women.
Patients with abdominal mass or ascites.• Patients posted for emergency surgery.
Contraindication for spinal anaesthesia.
BMI more than 30 kilogram per meter square
Patients who are on drugs which is affecting vascular status and tone. Example, Diuretics, Vasodilators and alpha blockers etc.
Patients who are requiring over night hydration. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
which fluid is better in terms of reduction of Inferior vena cava collapsibility index. Ringer lactate or sterofundine  Preloading:IVCCI measured before fluid administration (fasting state).
Post-Preloading: IVCCI measured immediately after 500 ml fluid administration.
Post-Spinal Anesthesia: IVCCI measured at 15 minutes and 30 minutes after spinal anesthesia. 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of hypotension after spinal anesthesia in both groups.
Requirement for inotropes (example, ephedrine) to manage hypotension.
Hemodynamic changes (heart rate, blood pressure) post-spinal anesthesia. 		 Up to 30 minutes post-spinal anesthesia.
During the first 30 minutes after spinal anesthesia.
Monitored continuously, with specific measurements at 15 minutes and 30 minutes after spinal anesthesia. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   19/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

AIM OF STUDY

           To compare response of IVCCI to preloading between Ringer lactate and sterofundin.

 

 

 

OBJECTIVES                                                        

PRIMARY OBJECTIVE:

            To compare reduction in percentage of IVCCI between two groups RL and sterofundin, In fasting after giving 500ml fluids and 15 and 30 minutes of spinal anaesthesia.

 

SECONDARY OBJECTIVE:

        To compare incidence of hypotension between two groups.

         The requirement for inotropes and the resulting hemodynamic changes.

 

STUDY PROTOCOL:

·       ETHICAL CONSIDERATION: This study will be conducted after obtaining ethical approval by local ethical committee of GMERS MEDICAL COLLEGE AND HOSPITAL, Vadodara and topic being registered with CTRI (clinical trial registry of India)

·       STUDY DESIGN: This is a prospective, comparative observational study will be conducted in the pre-operative recovery area and the operation theatre of GMERS Medical College, Gotri, Vadodara. The study will compare the effects of Ringer’s Lactate (Group RL) and Sterofundin (Group SF) on the inferior vena cava collapsibility index (IVCCI) and the incidence of spinal-induced hypotension in fasting patients undergoing elective lower limb surgeries under spinal anaesthesia.

 

Group RL: Patients will receive Ringer’s Lactate (RL).

Group SF: Patients will receive Sterofundin (SF).

 

·       STUDY PLACE: Orthopaedic surgery operating unit in a tertiary care teaching hospital (GMERS Medical college and Hospital, Vadodara)

        STUDY PERIOD: Over the period 3 -5 months after the approval from ethical committee.

·        STUDY POPULATION: Adults consenting for checking IVC posted for Lower limb orthopaedic surgery with comparable demographic profile.

·        SAMPLE SIZE: We would like to derive the sample size from a study comparing RL and SF (different from ours), taking into consideration the IVCCI for the assessment of fluid responsiveness in spontaneously breathing preoperatively fasting patients or from the pilot cases after discussion with Statistics department.

 

INCLUSION CRITERIA:

1         Patients posted for lower limb orthopaedic surgery under spinal anaesthesia in supine position.

2         patients aged between 18 to 65 years.

3         patients with American society of anaesthesia physical status I and II

4         Patients listed for elective surgery.

5         Fasting for more than 8 hours.

 

EXCLUSION CRITERIA:

1         patients with American society of anaesthesia physical status III and more.

2         Pregnant women.

3         Patients with abdominal mass or ascites.

4         Patients posted for emergency surgery.

5         Contraindication for spinal anaesthesia.

6         BMI >30kg/m2

7         Patients who are on drugs which is affecting vascular status and tone. Eg: Diuretics, Vasodilators and alpha blockers etc.

8         Patients who are requiring over night hydration.

Pre-Study Preparation:

After proper informed written consent, patients of ASA- I & II physical status posted for Lower limb orthopaedic Surgeries will be recruited to participate in the study. Baseline vitals, including heart rate, blood pressure (BP), mean arterial pressure (MAP), and fasting duration, will be recorded for each patient. All patients will receive premedication and antibiotic prophylaxis as per institutional protocol.

 

Ultrasound-Guided IVC Measurements:

         Using a curvilinear probe of 3-5 MHz on an ultrasound (USG) machine, inferior vena cava (IVC) diameters will be measured in the subxiphoid view (long axis) 2 cm distal to the junction of the right atrium (RA) and IVC. Pulse-wave Doppler will be used to differentiate between the aorta and IVC.

  • Measurement Technique:     
    • Place the patient in a supine position.
    • Obtain a clear B-mode image of the IVC.
    • The image will be frozen after normal inspiration and expiration.
    • IVC diameters will be measured using the caliper feature of the ultrasound machine during both inspiration and expiration.
    • This process will be repeated for both time points (before and after fluid administration).

The IVC Collapsibility Index (IVCCI) will be calculated as follows:

  IVCCI = (IVC diameter in expiration - IVC diameter in inspiration / IVC diameter in expiration ) * 100 

Fluid Administration Protocol:

         Each patient will receive 500 ml of either Ringer’s Lactate (Group RL) or Sterofundin (Group SF) within 10-20 minutes, following the initial IVC measurements.

Spinal Anaesthesia:

         After fluid administration, spinal anaesthesia will be administered using 0.5% hyperbaric bupivacaine (15-18 mg) combined with 200 mcg of butorphanol. A 23G Quincke needle will be used for the spinal block, performed in the sitting position at L2 – L3 or L3 – L4 intervertebral space.

  • Timing: Spinal anaesthesia will be given immediately after fluid preloading.
  • T0 (Time Zero): The timer starts immediately after the administration of spinal anaesthesia.
  • The maintenance fluid rate is calculated according to the Holiday-Segar formula. For a 50 kg patient fasting for 10 hours, the formula is applied as follows:
    • Maintenance Fluid (MF) = 90 ml.
    • Deficit Fluid = MF × Fasting Hours = 90 × 10 = 900 ml.
    • Third Space Loss = Weight × 2 = 50 × 2 = 100 ml.
    • Total Fluid Requirement (1st hour) = 640 ml.

Fluids are administered at a calculated rate:

  • For a 50 kg patient: 106 mL per 10 minutes.
  • For a 60 kg patient: 120 mL per 10 minutes.
  • For a 70 kg patient: 134 mL per 10 minutes.

Monitoring:

Vitals (heart rate, BP, MAP) will be recorded at the following time points:

  • T15 (15 minutes post-spinal): Vitals and IVC measurements will be repeated.
  • T30 (30 minutes post-spinal): Vitals and IVC measurements will be repeated.

Intervention for Hypotension:

         If hypotension (MAP < 65 mmHg) occurs within the first 30 minutes post-spinal anaesthesia, an intramuscular injection of ephedrine 5 - 10 mg will be administered. Any changes in hemodynamic parameters following ephedrine administration will be recorded.

Study End Point:

         The study concludes 30 minutes after the administration of spinal anaesthesia. No further observations will be made after this time point.

Data Collection and Analysis:

  • IVCCI will be calculated before and after fluid administration and after spinal anaesthesia at T15, and T30.
  • Incidence of spinal-induced hypotension will be recorded.
  • The primary objective is to compare the reduction in IVCCI between Group RL and Group SF.
  • The secondary objective is to compare the incidence of spinal-induced hypotension between the two groups and the requirement for inotropes and the resulting hemodynamic changes.

 

 

Statistical Analysis:

       Data will be analysed using appropriate statistical tests to determine significant differences between the two groups. A p-value of < 0.05 will be considered statistically significant.


 
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