| CTRI Number |
CTRI/2024/03/064194 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Norepinephrine versus ephedrine to maintain arterial blood pressure during spinal anaesthesia for cesarean section |
|
Scientific Title of Study
|
Norepinephrine versus ephedrine to maintain arterial blood pressure during spinal anaesthesia for cesarean delivery |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sarvesh Kumar yogi |
| Designation |
Junior resident |
| Affiliation |
Sms medical college jaipur |
| Address |
Department of anaesthesia sms medical college jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8104325865 |
| Fax |
|
| Email |
sarveshyogi678@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Drshriphal meena |
| Designation |
Senior professor |
| Affiliation |
Sms medical college jaipur |
| Address |
Department of anaesthesia sms medical college jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9928350391 |
| Fax |
|
| Email |
dr.shriphal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Drshriphal meena |
| Designation |
Senior professor |
| Affiliation |
Sms medical college jaipur |
| Address |
Department of anaesthesia sms medical college
Jaipur
RAJASTHAN
302004
India |
| Phone |
9928350391 |
| Fax |
|
| Email |
Dr.shriphal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sms medical college jaipur |
|
|
Primary Sponsor
|
| Name |
Sms medical college |
| Address |
Jaipur |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shriphal meena |
Department of anaesthesia sms medical college |
Jaipur
Jaipur
RAJASTHAN |
9928350391
dr.shriphal@gmail.com |
| Dr Shriphal meena |
Mahila chikitsalya department of anaesthesia sms medical college jaipur |
Jaipur
Jaipur
RAJASTHAN |
9928350391
dr.shriphal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the ethics committee sms medical college and attached hospital jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, (2) ICD-10 Condition: O669||Obstructed labor, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ephedrine 10mg at time of intrathecal block plus rescue bolus of ephedrine 10mg at |
After given subarchnoid block in group B prophylactic bolus of ephedrine 10mg at time of intrathecal block plus rescue bolus of ephedrine 10mg whenever maternal systolic blood pressure dropped by 20% |
| Intervention |
Norepinephrine 5mcg bolus after givens subarchnoid block plus rescue bolus of norepinephrine 5mcg whenever systolic blood pressure dropped by 20%of baseline |
After given subarchnoid block in group A prophylactic bolus of norepinephrine 5ugm plus rescue bolusof 5ugm norepinephrine whenever systolic blood pressure dropped by 20% of baseline. In group B prophylactic bolus of ephedrine 10mg at time of intrathecal block pluse rescue bolus of 10mg ephedrine whenever maternal systolic blood pressure dropped by20% |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Informed consent,age between 20_40year,patients undergoing elective cesarean section delivery,nondiabetic,non hypertensive, |
|
| ExclusionCriteria |
| Details |
Emergency cesarean section, Active labor, high risk pregnancy (intrauterine growth restrictions, pre eclampsia),maternal cardiovascular disease, chronic kidney and liver and pulmonary disease |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean arterial blood pressure. No.of rescue bolus of norepinephrine (5umg)and ephedrine (10mg)used,incidence of bradycardia/tachycardia, Neonatal Apgar score in both group |
Till given of subarchnoid block to compilations of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1 Incidence of bradycardia/tachycardia . 2 Neonatal Apgar score in both group |
After given subarchnoid block to compilation of surgery |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
20/03/2024 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After the institutional ethics committee approved, after checking fasting status, informed consent and pac,I’ve access will be procedured. The baseline parameter, heart rate ,oxygen saturation ecg and arterial blood pressure will be recorded. Patient will be positioned in sitting position, under all asceptic precautions Ths patient will be painted with providine iodine solution . then selected site will be draped with sterilized hole towel . Intervertebral space between L4-L5/L3-L4 intervertebral space will be identified . A 25 G spinal needle is inserted on marked area after confirming free flow of clear CSF drug 12.5 milligrams of hyperbaric bupivacaine 0.5% was injected and patient will be immediately placing supine position.In group A prophylactic bolus of Norepinephrine 5mcg at time of intrathecal block plus rescue bolus of 5mcg Norepinephrine ,whenever maternal systolic blood pressure dropped by 20% of baseline value.
In group B prophylactic bolus of ephedrine 10mg at time of intrathecal block plus rescue of 10mg ephedrine, whenever maternal systolic blood pressure dropped 20% of baseline value. Intra operative period ,blood pressure ( SBP, DBP, MAP),Heart rate oxygen saturation noted at every 2 minutes till delivery of fetus and every 5 minutes delivery.
Neonatal outcome was assessed by APGAR score at first minut and five minut. |