| CTRI Number |
CTRI/2021/07/035125 [Registered on: 26/07/2021] Trial Registered Prospectively |
| Last Modified On: |
25/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial to compare the effects of norepinephrine and phenylephrine infusion in prevention of hypotension after spinal anaesthesia in elective cesarean section |
|
Scientific Title of Study
|
Comparison of Norepinephrine and Phenylephrine infusion for prevention of hypotension after spinal anaesthesia in patients undergoing elective cesarean section |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shridevi P Edigar |
| Designation |
Post graduate student |
| Affiliation |
Dr S N Medical college Jodhpur |
| Address |
Department of anaesthesiology
Jodhpur
RAJASTHAN
342001
India |
| Phone |
7259721217 |
| Fax |
|
| Email |
shrideviedigar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarita Janweja |
| Designation |
Senior professor |
| Affiliation |
Dr S N Medical college Jodhpur |
| Address |
Department of anaesthesia
Dr S N Medical college
Jodhpur
Department of anaesthesia
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9829116420 |
| Fax |
|
| Email |
Sarita.janweja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shridevi P Edigar |
| Designation |
Post graduate student |
| Affiliation |
Dr S N Medical college Jodhpur |
| Address |
room no14 pg hostel mgh hospital
RAJASTHAN
342001
India |
| Phone |
7259721217 |
| Fax |
|
| Email |
shrideviedigar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Umaid hospital
Dr SN medical college ,Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr Shridevi P Edigar |
| Address |
Department of anaesthesia
Dr S N Medical college ,jodhput |
| Type of Sponsor |
Other [Principal investigator ] |
|
|
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 |
| Dr shridevi P Edigar |
Umaid hospital jodhpur |
Main ot complex ,1st floor
Department of anaesthesiology
Jodhpur
RAJASTHAN |
7259721217
shrideviedigar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics commmittee ,Dr S N Medical college Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Iv infusion of norepinephrine |
Iv infusion of the norepiinephrine will be started after the csf tap and stopped at clamping of umbelical cord and delivery of the baby. |
| Comparator Agent |
Iv infusion of phenylephrine |
Iv infusion of phenylephrine is started after csf tap and stopped after clamping of umbelical cord and delivery of baby |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women with singleton pregnancy with age between 18years and 40years and gestation period between 36weeks to 40 weeks who comes under The American Society of Anaesthesiologists physical status â…¡ who are undergoing cesarean section under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
1.Refusal for study
2.allergic to local anaesthetics or study drug
3.infection at insertion site
4.use of cardiac medication or medication for blood pressure control ,cardiovascular disease,hypertensive disorders of pregnancy ,eclamsia
5.Gestation diabetes requiring insulin
6.History of post operative nausea and vomiting
7.History of chronic opioid use(chronic pain syndrome)
8.cesarean delivery for maternal and/or fetal distress |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of infusion of norepinephrine and infusion of phenylephrine for prevention of hypotension after spinal anaesthesia in elective cesarean section |
To comapare number of rescue boluses of ephedrine 0.6 mg to treat hypotension in both the groups from the time of sub arachnoid block till completion of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Two compare the following between two groups
Hemodynamic parameters like heart rate,respiratory rate,spo2
incidence of adverse effects
neonatal apgar score at 1min and 5 min
neonatal umbelical vein sample for ph,po2,hco3 |
heart rate less than 60,nausea and vomiting,apgar score intraoperatively till the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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 |
|
Date of First Enrollment (India)
|
01/08/2021 |
| 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="1"
Days="1" |
|
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
|
This study is interventional prospective Randomised Comparative Trial aiming to study the efficacy and safety of infusion of norepinephrine and phenylephrine for prevention of hypotension after spinal anaesthesia in patirnts undergoing elective cesarean section in 84 patients . This study will be conducted in Dr S N Medical college and associated group of hospitals Jodhpur Rajasthan .The primary outcome is to compare the number of rescue boluses of ephedrine required to treat hypotension in both the groups. This study will be conducted under guidance of my guide and there is no financial burden on patients. This study is ethically justified by IEC Dr S N Medical college , Jodhpur Rajasthan. |