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CTRI Number  CTRI/2021/07/034758 [Registered on: 12/07/2021] Trial Registered Prospectively
Last Modified On: 10/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   "The Role of 6% Hydroxyethyl starch and Ringers lactate for preloading in patients undergoing elective caesarean section under spinal anaesthesia " 
Scientific Title of Study   "The Role of 6% Hydroxyethyl starch and Ringers lactate for preloading in patients undergoing elective caesarean section under spinal anaesthesia - A Prospective randomised clinical study " 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sudarshan Yadav B V 
Designation  Resident Doctor 
Affiliation  Government medical college ,Baroda 
Address  Department of anaesthesiology,New surgical block ,SSG Hospital,Vadodara, Gujarat 390001

Vadodara
GUJARAT
390001
India 
Phone  8892525095  
Fax    
Email  siddu2281@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swati Bhatt 
Designation  Head of Department and Professor 
Affiliation  Government medical college ,Baroda 
Address  Department of anaesthesiology,New surgical block ,SSG Hospital,Vadodara, Gujarat 390001

Vadodara
GUJARAT
390001
India 
Phone  6355626482  
Fax    
Email  drswatibhatt2015@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Swati Bhatt 
Designation  Head of Department and Professor 
Affiliation  Government medical college ,Baroda 
Address  Department of anaesthesiology,New surgical block ,SSG Hospital,Vadodara, Gujarat 390001

Vadodara
GUJARAT
390001
India 
Phone  6355626482  
Fax    
Email  drswatibhatt2015@yahoo.com  
 
Source of Monetary or Material Support  
Department of anesthesia GOVT MEDICAL COLLEGE SSG HOSPITAL VADODARA 
 
Primary Sponsor  
Name  Government medical college Baroda 
Address  Department of Anaesthesiology,SSG hospital,Vadodara, GUJARAT 390001 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 
SUDARSHAN YADAV B V  SSG HOSPITAL VADODARA  Rukmani chainani labour room SSGH VADODARA
Vadodara
GUJARAT 
6352390147

siddu2281@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics commitee for biomedical and health research (IECHBR) Medical college and SSG Hospital ,Baroda.   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, (2) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  6% Hydroxyethyl starch and Ringers lactate solution  To study the role of Preloading with 6% Hydroxyethyl starch and Ringers lactate solution in patients undergoing elective caesarean section under spinal anaesthesia 
Intervention  Preloading with 1000ml ringers lactate solution in patients undergoing elective caesarean section under spinal anaesthesia  Baseline haemodynamic parameters noted and monitoring will be done till the end of surgery. Dose of Ephedrine required to treat hypotension will be noted. To assess the neonatal outcome and side effects of spinal anaesthesia 
Intervention  Preloading with 6%Hydroxyethylstarch in patients undergoing elective caesarean sectioin under spinal anaesthesia  Baseline haemodynamic parameters noted and monitoring done till the end of surgery. To calculate the requirement of ephedrine to treat hypotension when preloaded with 6% HES. To assess the neonatal outcome and side effects of HES as well as complications of spinal anesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  ASA I AND II 
 
ExclusionCriteria 
Details  Unwillingness of the patient.
BMI >25kg/meter square, Height less than 152cms.
Patients with Multiple gestation.
Patients with spine deformity,previous history of spine surgeries.
Severe anemia,coagulation abnormalities and bleeding disorders.
Patients with active skin lesions over lumbosacral region.
Medical disorders like chronic hypertension,diabetes,liver disease,renal diseases(calculi,stenosis,altered renal function tests), and CVS abnormalities(MI,Heart blocks etc).


 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the incidence of hypotension while using 6% HES or Ringers lactate for preloading who are undergoing elective caesarean section under spinal anaesthesia.  To compare the incidence of hypotension while using 6% HES or Ringers lactate for preloading who are undergoing elective caesarean section under spinal anaesthesia.
Patient will be monitored upto 24hrs after surgey  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the requirement of ephedrine to treat hypotension when preloaded with 6%HES or ringers lactate.
To assess the neonatal outcome in both the groups.
To study the side effects of HES as well as complications of spinal anesthesia. 
Patients who develop hypotension will be treated with IV boluses of ephedrine and total requirements will be noted .Other side effects like bradycardia and allergic reactions will be noted and treated accordingly.
allergic reactions to HES will be noted.
Neonatal outcome will be maesured by APGAR score at 1st and 5th minute of delivery.
Patients will be monitored postoperatively every 2hrly till 24hrs  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 2 
Date of First Enrollment (India)   12/07/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Patients will be checked for NBM status of minimum 8hrs.
After thorough pre anesthesia checkup all the patients sufficing the inclusion criteria will be selected ,procedure of spinal anaesthesia and purpose of the study will be explained and informed written consent will be taken.
TROLLEY PREPARATION:Cylinders and circuits to be checked ,multipara monitor,  airway equipment,L P tray (consisting of 23G ,2cc syringe,needle,wound towel,cotton swabs ,gauze pieces) and drugs required for spinal anesthesia to be kept ready for induction.
After taking patient inside the operation theatre , a wedge will be put on the right side and oxygen will be given through facemask, intravenous access will be secured with 18G IV cannula, multipara monitor will be attached and baseline vital parameters (Pulse,SBP,DBP,MAP) and Spo2 will be noted.
PRE MEDICATIONS:
Inj Glycopyrrolate 5ug/kg IV
Inj Rantac 50mg IV 
Inj Ondansetron 0.1mg/kg IV
GROUPING OF PATIENTS:
Patients will be divided in to 2 groups with the  help of randomistaion (using sealed envelope method).
GROUP1: Preloading with 500ml of 6% HES 20mins before induction.
GROUP2:Preloading with 1000ml of Ringers lactate 20mins before induction.

ANESTHESIA TECHNIQUE:
Patient will be put into the left lateral position and under all aseptic precautions spinal anesthesia will be performed at L2-3 or L3-4 interspaces .The skin will be infiltrated with 2ml of 2 percent local anesthesia(lignocaine)and then using a 23 gauuge Quincke needle pointing cephalad all patients in the study will recieve 2cc (10mg) of 0.5% Injection Bupivacaine heavy .After giving spinal anesthesia patient will be positioned supine ,oxygen @5L/min will be adminstered by using facemask.  

MONITORING AND OBSERVATIONS :
SPINAL BLOCKADE ASSESMENT:
Surgery will be commenced once the level of sensory blockade is T6 dermatomal level by pinprick method and motor blockade is grade 3 according to Bromage scale.

HAEMODYNAMIC ,SPO2 AND UOP MONITORING:
Baseline haemodynamic parameters (pulse rate,SBP.DBP,MAP),SPO2 and UOP will be measured and then monitoring will be done after preloading ,after giving spinal anesthesia at 1,3,5,7,10.15.20 mins and at 5mins intervals of both the groups till the end of surgery .
Patients who develop hypotension (fall in blood pressure >20% from the baseline) will be treated with IV Boluses of 5mg Ephedrine , additional doses of ephedrine will be repeated if hypotension persists ,and the requirements will be noted throughout the intra operative period .Other side effects like bradycardia (HR Less than 20% of baseline) and allergic reactions will be treated with Inj Atropine 0.6mg IV and Inj AVIL +Inj DEXONA respectively if required. 
If patients are having any allergic reactions to HES it will be noted ,and our study will be discontinued .If patients are getting to converted to General anesthesia they will be excluded from study .
Following the delivery,the neonatal outcome will be maesured by APGAR SCORE at 1st and 5th minute of delivery .Patients will be monitored postoperatively every 2hrly till 24hrs.
 
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