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
|
|
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
|
|
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.
|