| CTRI Number |
CTRI/2025/12/098339 [Registered on: 02/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
The effect of hypotension prevention drugs on newborns |
|
Scientific Title of Study
|
Comparison of Two Prophylactic Norepinephrine Doses for Prevention of Post-Spinal Hypotension on Umbilical Artery and Vein Blood-Gas Parameters in Patients Undergoing Elective Caesarean Section: A Randomized Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr CH RAMA KRISHNA PRASAD |
| Designation |
Associate Professor |
| Affiliation |
AIIMS BIBINAGAR |
| Address |
Room 50, Department of Anaesthesia, AIIMS Bibinagar, Hyderabad
Hyderabad TELANGANA 508126 India |
| Phone |
09885718133 |
| Fax |
|
| Email |
ramakrishna.chikkala19@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr CH RAMA KRISHNA PRASAD |
| Designation |
Associate Professor |
| Affiliation |
AIIMS BIBINAGAR |
| Address |
Room 50, Department of Anaesthesia, AIIMS Bibinagar, Hyderabad
Hyderabad TELANGANA 508126 India |
| Phone |
09885718133 |
| Fax |
|
| Email |
ramakrishna.chikkala19@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr CH RAMA KRISHNA PRASAD |
| Designation |
Associate Professor |
| Affiliation |
AIIMS BIBINAGAR |
| Address |
Room 50, Department of Anaesthesia, AIIMS Bibinagar, Hyderabad
Hyderabad TELANGANA 508126 India |
| Phone |
09885718133 |
| Fax |
|
| Email |
ramakrishna.chikkala19@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Room 50, Department of Anaesthesia, AIIMS Bibinagar, Hyderabad |
| Type of Sponsor |
Other [] |
|
|
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 |
| Rama Krishna Prasad CH |
AIIMS BIBINAGAR |
Room 50, Department of Anaesthesia, AIIMS Bibinagar, Hyderabad Hyderabad TELANGANA |
09885718133
ramakrishna.chikkala19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS BBN-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NE 0.04 |
NOREPINEPHRINE 0.04 µg/kg/min started as an infusion from the beginning of surgery till the closure via the intravenous route |
| Intervention |
NE 0.08 |
norepinephrine 0.08 µg/kg/min started as an infusion from the beginning of surgery to till end of surgery via the intravenous route |
| Comparator Agent |
NS |
Normal saline infusion started as an infusion from the beginning of surgery to till the end of surgery via intravenous route |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 18–35 years, full-term pregnant, scheduled for elective caesarean section under spinal anaesthesia, and belonging to ASA class II |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Foetal blood gas parameters obtained from umbilical artery and venous samples immediately after cord clamping |
Immediately after the delivery of the baby |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Apgar scores |
1 & 5 minutes after delivery |
| Hear rate, blood pressure |
1,2,15,30,45,60 minutes after delivery |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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 4 |
|
Date of First Enrollment (India)
|
15/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Spinal anaesthesia is the preferred technique for an elective caesarean section as it decreases airway manipulation and other potential complications related to GA1. Hypotension is the most common complication of spinal anaesthesia during caesarean delivery. As it can have adverse effects on the mother as well as the foetus, timely management of post-spinal hypotension is extremely important. Although various methods have been tried to reduce the incidence, vasopressors remain the mainstay of management of post-spinal hypotension. Most common vasopressors used are phenylephrine, ephedrine and norepinephrine. Phenylephrine causes decreased maternal heart rate and subsequent fall in cardiac output. Ephedrine causes maternal tachycardia and decreases fetal pH. Norepinephrine has emerged as an effective prophylactic vasopressor with a favourable balance between maintaining maternal blood pressure and minimizing reflex bradycardia. Norepinephrine has dual alpha and beta agonist activity maintaining maternal cardiac output. Current evidence on noradrenaline use in obstetric anaesthesia focuses mainly on maternal hemodynamic outcomes (blood pressure, heart rate, incidence of hypotension). Foetal outcomes, particularly blood gas parameters, are underexplored. Comparative data between different prophylactic dosages of noradrenaline and their impact on foetal physiology are lacking. Although there are abundant literature2 about norepinephrine infusion and bolus in caesarean section, but till recently no study has been done in Indian population comparing the effect of different doses of norepinephrine on Foetal blood gas parameters. This study addresses this gap by providing data on umbilical cord blood gases following two distinct norepinephrine prophylaxis regimens, thereby offering new insight into fetal acid–base balance in the context of spinal anaesthesia for caesarean delivery. This study aims to compare norepinephrine 0.04mcg/kg/min, 0.08mcg/kg/min and a placebo on fetal blood gas parameters in Indian population. |