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CTRI Number  CTRI/2020/02/023526 [Registered on: 24/02/2020] Trial Registered Prospectively
Last Modified On: 18/02/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to know which method is better to prevent fall in blood pressure in cesarean section  
Scientific Title of Study   Comparison of head elevated position and Inj. Ondansetron in reducing spinal anesthesia induced hypotension in elective lower segment caesarean section: an open labeled randomized control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mita Eunice Sarkar 
Designation  Consultant 
Affiliation  Bangalore Baptist hospital 
Address  Bangalore Baptist Hospital, Hebbal ,Bellary road ,Bangalore

Bangalore
KARNATAKA
560024
India 
Phone  9980670790  
Fax    
Email  mitasarkar7@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mita Eunice Sarkar 
Designation  Consultant 
Affiliation  Bangalore Baptist hospital 
Address  Bangalore Baptist Hospital, Hebbal ,Bellary road ,Bangalore

Bangalore
KARNATAKA
560024
India 
Phone  9980670790  
Fax    
Email  mitasarkar7@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mita Eunice Sarkar 
Designation  Consultant 
Affiliation  Bangalore Baptist hospital 
Address  Bangalore Baptist Hospital, Hebbal ,Bellary road ,Bangalore

Bangalore
KARNATAKA
560024
India 
Phone  9980670790  
Fax    
Email  mitasarkar7@yahoo.com  
 
Source of Monetary or Material Support  
Bangalore Baptist Hospital Bellary road,Hebbal Bangalore-560024 
 
Primary Sponsor  
Name  Bangalore Baptist Hospital 
Address  Bangalore Baptist Hospital, Hebbal, Bellary road, Bangalore 560024 
Type of Sponsor  Private hospital/clinic 
 
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 
Mita Eunice Sarkar  Operation Theatre Bangalore Baptist Hospital  Operation Theatre, Department of Anesthesiology, 1st floor, Bangalore Baptist hospital, Hebbal, Bellary road, Bangalore 560024
Bangalore
KARNATAKA 
9980670790

mitasarkar7@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bangalore Baptist hospital Institutional review Board  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control  No use of inj. ondansetron or head elevation 
Comparator Agent  Head elevation  Head elevation using pillow under head and shoulders during and after spinal anesthesia 
Intervention  inj Ondansetron  Inj Ondansetron 0.1mg/kg IV single dose, 5 minutes prior to spinal anesthesia 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Parturients for Cesarean Section 
 
ExclusionCriteria 
Details  BMI >35
ASA3
Severe fetal distress
Obstetric complications
Medical disease complicating pregnancy
Sitting position
Drug volume> or< than 2 ml
Contraindication to spinal anesthesia
Allergy to ondansetron
Parturients on medicines acting on 5HT3
Conversion to general anesthesia
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Fall in Blood pressure  After spinal anesthesia at 1,2,3,4,5,10,15,20,25,30,35,40,45,50,55 and 60 minute  
 
Secondary Outcome  
Outcome  TimePoints 
Vomiting, maximal sensory block level, bradycardia,   After spinal anesthesia at 1,2,3,4,5,10,15,20,25,30,35,40,45,50,55 and 60 minute  
 
Target Sample Size   Total Sample Size="750"
Sample Size from India="750" 
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   N/A 
Date of First Enrollment (India)   01/03/2020 
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="2"
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)?  

Brief Summary  

Hypotension is one of the most common immediate complications of spinal anesthesia. Preloading with fluids is one way of preventing hypotension. However hypotension still occurs in many patients which is managed by pharmacological interventions. In this study, we are comparing three modalities which can prevent hypotension. Based on the findings of the study, we want to standardize the care in our hospital.

There are no studies comparing the use of head elevated position and intravenous Ondansetron in reducing spinal induced hypotension in obstetrics. Both these interventions are simple, cost effective and carry negligible risk hence were chosen for the study.

Group H: Parturients will receive head end elevation during and after spinal anaesthesia and will remain in this position till the end of the surgery. They will not receive Inj. Ondansetron prior to spinal anesthesia.

Group O; Parturients will receive Inj. Ondanstron 4 mg i.v five minutes prior to spinal anesthesia.

Group C: Parturients will neither be given head end elevation post spinal anaesthesia nor will receive Inj. Ondansetron i.v prior to spinal anaesthesia.(standard of care)

Standard protocol for perioperative monitoring and administration of spinal anaesthesia will be followed.

Hemodynamic parameters which include systolic, diastolic and mean arterial pressures and heart rate will be measured and recorded before spinal anaesthesia administration, just after spinal anaesthesia, at 1 minute intervals for the first 5 minutes, then at 5 minute intervals till the end of surgery.

 The total dose of ephedrine required will be noted

Sensory block will be assessed using a cold swab and motor block by modified Bromage scale every 3 minutes for 15 minutes, beyond which parturient will be excluded if sensory block is below T6.

 Time from spinal injection to T6 sensory level, maximal sensory block level (MSBL) attained, time at which MSBL was achieved, time to skin incision, time to two segment regression of the sensory block will be recorded.

Other side effects of spinal anesthesia like nausea, vomiting and shivering will be noted.

 

APGAR at 1minute and 5 minutes will also be recorded.

 

 
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