| CTRI Number |
CTRI/2025/01/079503 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
26/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Prevention of low blood pressure in pregnant women undergoing caesarean delivery |
|
Scientific Title of Study
|
Comparison of nebulised Phenylephrine and nebulised Norepinephrine for prevention of Post Spinal Hypotension in patients undergoing Elective Caesarean delivery: A double blind, Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chirag Bhati |
| Designation |
Anaesthesia academic Junior Resident |
| Affiliation |
All India institute of medical sciences Patna |
| Address |
C5B, Department of Anaesthesiology, 5th floor, IPD complex, AIIMS Patna, Phulwarisharif, Patna, BIHAR 801507, India
Patna BIHAR 801507 India |
| Phone |
9214376492 |
| Fax |
|
| Email |
chiragbhati999@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Neeraj Kumar |
| Designation |
Associate professor |
| Affiliation |
All India institute of medical sciences Patna |
| Address |
Room No 505, Department of Anaesthesiology, B Block OT complex, AIIMS Patna, Phulwarisharif, Patna, BIHAR 801507,India
Patna BIHAR 801507 India |
| Phone |
8210104972 |
| Fax |
|
| Email |
neeraj.jlnmc@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Neeraj Kumar |
| Designation |
Associate professor |
| Affiliation |
All India institute of medical sciences Patna |
| Address |
Room No 505, Department of Anaesthesiology, B Block OT complex, AIIMS Patna, Phulwarisharif, Patna, BIHAR 801507,India
BIHAR 801507 India |
| Phone |
8210104972 |
| Fax |
|
| Email |
neeraj.jlnmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India institute of medical sciences, Phulwarisharif, Patna, Bihar, India. Pin code- 801507 |
|
|
Primary Sponsor
|
| Name |
All India institute of medical sciences, Patna |
| Address |
Department of anaesthesiology, B block OT complex, AIIMS Patna, Phulwarisharif, Patna, Bihar-801507 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Chirag Bhati |
All India institute of medical sciences |
Department of Anaesthesia, B Block OT complex, All India institute of medical sciences Patna, Phulwarisharif, Patna, BIHAR 801507,India Patna BIHAR |
9214376492
chiragbhati999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, AIIMS Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nebulization with Norepinephrine |
Ultrasonic nebulisation of 40 mcg norepinephrine in 4 ml solution (10 mcg/ml) at the rate of 2.5 mcg/min till the delivery of fetus |
| Comparator Agent |
Nebulization with normal saline |
ultrasonic nebulisation of 4 ml volume 0.9% normal saline nebulization till the delivery of fetus |
| Intervention |
Nebulization with Phenylephrine |
Ultrasonic nebulization of 200 mcg phenylephrine diluted in 4 ml solution; i.e. (50 mcg/ml) at the rate of 12.5 mcg/min till the delivery of fetus |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women undergoing elective caesarean section under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patient refusal,
Patient Allergic or hypersensitive to phenylephrine or norepinephrine,
Preterm pregnancy,
Twin pregnancy,
ASA III, IV patient,
Preeclamptic patient,
Patient undergoing emergency caesarean section |
|
|
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 |
| Incidence of Post spinal hypotension after receiving prophylactic nebulised dose of phenylephrine and norepinephrine in patient undergoing elective caesarean section |
Till the end of the operation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Neonatal APGAR score |
At 1 mins, 5 mins |
| • Any change in neonatal umbilical venous sampling for blood gas analysis. |
Just after delivery |
| • Requirement of IV bolus dose of Phenylephrine (50 mcg) |
During caesarean section |
| • Total volume of crystalloids (ml) |
During caesarean section |
| • Any adverse events like nausea, vomiting and shivering |
During caesarean section |
| • Incidence of reflex bradycardia |
During caesarean section |
|
|
Target Sample Size
|
Total Sample Size="99" Sample Size from India="99"
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)
|
06/02/2025 |
| 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 Yet Recruiting |
| 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
|
Post spinal hypotension is a common and potentially serious complication in patients undergoing elective caesarean delivery under spinal anaesthesia. It can lead to significant maternal and fetal morbidity if not effectively managed. Traditionally, vasopressors such as phenylephrine and norepinephrine are utilized to mitigate this issue due to their vasoconstrictive properties, which help maintain blood pressure. However, the optimal choice of vasopressor remains a subject of ongoing debate. Phenylephrine, a selective alpha-1 adrenergic receptor agonist, is widely used and well-documented for its efficacy in maintaining hemodynamic stability during spinal anaesthesia. Nevertheless, it is associated with reflex bradycardia and decreased cardiac output, which can be detrimental in some cases. On the other hand, norepinephrine, which acts on both alpha and beta-adrenergic receptors, has gained attention for its potential to provide more balanced hemodynamic support with less impact on heart rate and cardiac output. This double-blind randomized controlled study aims to compare the efficacy and safety of nebulised phenylephrine versus nebulised norepinephrine in preventing post spinal hypotension in patients undergoing elective caesarean delivery. By evaluating the hemodynamic profiles, maternal and fetal outcomes, and potential side effects of these two vasopressors, this study seeks to provide evidence-based guidance for optimizing maternal care during caesarean sections |