| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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, |
|
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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).
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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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 |
|
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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
|
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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. |