| CTRI Number |
CTRI/2022/07/044398 [Registered on: 27/07/2022] Trial Registered Prospectively |
| Last Modified On: |
12/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of a drug (norepinephrine) for prevention of fall in BP in pregnant patients posted for delivery with operation during spinal anaesthesia |
|
Scientific Title of Study
|
Prophylactic norepinephrine infusion in preventing hypotension during spinal anaesthesia for caesarean delivery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chanchel mary thomas |
| Designation |
Resident |
| Affiliation |
RNT MEDICAL COLLEGE and MB Hospital |
| Address |
Department of anaesthesiology, RNT Medical College AND MB Hospital
Udaipur
RAJASTHAN
313001
India |
| Phone |
9884609119 |
| Fax |
|
| Email |
chanchelmarythomas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram Bedi |
| Designation |
Senior Professor |
| Affiliation |
RNT Medical College and MB Hospital |
| Address |
Department of Anaesthesia,RNT MEDICAL COLLEGE And MB Hospital
Udaipur
RAJASTHAN
313001
India |
| Phone |
9829025373 |
| Fax |
|
| Email |
vbedimd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chanchel Mary Thomas |
| Designation |
Resident |
| Affiliation |
RNT Medical College and MB Hospital |
| Address |
Department of Anaesthesiology, RNT MEDICAL COLLEGE
Udaipur
RAJASTHAN
313001
India |
| Phone |
9884609119 |
| Fax |
|
| Email |
chanchelmarythomas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, RNT Medical college, Udaipur |
|
|
Primary Sponsor
|
| Name |
RNT Medical College and MB Hospital |
| Address |
RNT Medical College and MB Hospital |
| 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 |
| Dr Chanchel mary thomas |
Pannadhay Zanana Hospital |
CLR Operation Theater, 2nd floor
Udaipur
RAJASTHAN |
9884609119
chanchelmarythomas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RNT MEDICAL COLLEGE AND CONTROLLER AND ATTACHED HOSPITAL, UDAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A-Norepinephrine infusion |
Prophylactic norepinephrine infusion started at 5 microgram/ml |
| Comparator Agent |
Group B-Normal saline infusion |
Infusion of normal saline 5 microgram/mL started at 30mL/hr |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
American society of anaesthesiologists physical status less than 3
Nonlaboring,
Normotensive,
Term and singleton pregnancy taken up for elective caesarean section under spinal anaesthesia like previous caesarean section,
Breech presentation,
Cephalopelvic disproportion,
Pregnancy following infertility treatment,
Cord round neck,
Non progression of labour,
Baseline systolic BP 90-140 mm Hg |
|
| ExclusionCriteria |
| Details |
Patient refusal,
Emergency indication of caesarean section like antepartum haemorrhage,
Fetal distress,
Obstructed labour,
Umbilical coed prolapse,
Preeclampsia,
Gestational diabetes,
Essential hypertension,
More than 2 previous lscs,
History of PPH,
Multiple gestation,
Patients with associated systemic illness,
History of seizures,
Coma,neurological signs or
Symptoms,any allergy to local anaesthetic agent,
Weight<50kg>100kg
Height <140cm>180cm. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of hypotension
|
Intraoperatively till delivery of baby (30min) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total norepinephrine consumption, Haemodynamic parameters, rescue doses of vasopressor |
Intraoperatively (1hr) |
|
|
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)
|
01/08/2022 |
| 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="0"
Days="6" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hypotension is the most common anaestheisa induced complication encountered in patients undergoing caesarean section under spinal anaesthesia.This study aims at evaluating the role of manually titrated infusion of norepinephrine in prevention of hypostension in parturients undergoing lower segment caesarean section under sub arachnoid block. |