| CTRI Number |
CTRI/2023/06/053854 [Registered on: 14/06/2023] Trial Registered Prospectively |
| Last Modified On: |
13/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the outcome of new born babies by prophylactive use of two drugs ( Phenylephrine or Noradrenaline) during spinal anaesthesia for cesarean delivery. |
|
Scientific Title of Study
|
Neonatal outcome following prophylactic phenylephrine or noradrenaline infusion during spinal Anesthesia for emergency caesarean delivery: a randomised controlled trail |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chandni Sinha |
| Designation |
Additional Professor |
| Affiliation |
All India institute of medical sciences |
| Address |
Room NO. 502
Department of Anesthesia
IPD 5th floor OT Complex
AIIMS Patna
Phulwarisarif,
Patna
Patna
BIHAR
801507
India |
| Phone |
7250333148 |
| Fax |
|
| Email |
chandni.doc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Soumya singh |
| Designation |
Senior resident |
| Affiliation |
All India institute of medical Science |
| Address |
Departement of Anesthesia
Aiims Patna
Aiims Patna
Patna
BIHAR
801507
India |
| Phone |
9916487314 |
| Fax |
|
| Email |
soumyasingh0123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soumya singh |
| Designation |
Senior resident |
| Affiliation |
All India institute of medical sciences |
| Address |
Departement of Anesthesia
Aiims Patna
Aiims Patna
Patna
BIHAR
801507
India |
| Phone |
9916487314 |
| Fax |
|
| Email |
soumyasingh0123@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Patna |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Science Patna |
| Address |
All India Institute of Medical Sciences 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 Soumya Singh |
Aiims Patna |
Aiims Patna labour room operating room
Patna
BIHAR |
9916487314
soumyasingh0123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O771||Fetal stress in labor or deliverydue to drug administration, (2) ICD-10 Condition: O758||Other specified complications of labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Noradrenaline
|
Noradrenaline infusion at the rate of 0.05 micrograms per kilogram per minute from the administration of spinal anesthesia to till delivery of placenta. |
| Intervention |
Phenylephrine |
Phenylephrine infusion at the rate of 0.75 micrograms per kilogram per minute from the administration of spinal anesthesia to till delivery of placenta. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
ASA 1 or 2 Healthy women with singleton pregnancy undergoing caesarean section and Non reassuring foetal heart rate >160, <100 bpm
|
|
| ExclusionCriteria |
| Details |
Patient’s refusal
pregnancy induced hypertension
Multiple gestation
Cardiovascular , Cerebrovascular disease
Patients with severely compromised fetus, chronic hypoxia (Biophysical Profile < 6) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Base excess on cord blood gas analysis
|
Just after the delivery of placenta
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| APGAR score |
1 minute and 5 minutes after delivery |
Admission to NICU
|
after delivery |
| Incidence of bradycardia, hypotension and arrythmia |
intraoperatively |
| Incidence of nausea and vomiting |
after delivery upto 4 hours |
| satisfaction score |
24 hours after delivery |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
26/06/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None as of now |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Phenylephrine is the vasopressin of choice in spinal induced hypotension in caesarean section. However increasing the dose might be associated with reflex bradycardia. Noradrenaline is a newer option with similar efficacy. Hence this study will compare the two drugs |