| CTRI Number |
CTRI/2025/01/079273 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Three groups of participants will be given PHENYLEPHRINE 75mcgs,PHENYLEPHRINE 100mcgs and NS along with oxytocin as an intervention and best hemodynamic balance outcome will be observed . |
|
Scientific Title of Study
|
A randomised comparative study on the effect of concomitant
administration of various doses of intravenous phenylephrine with oxytocin for prevention of oxytocin-induced hypotension following caesarian section under spinal anesthesia.
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Brinda Badam |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
DR D.Y. PATIL MEDICAL COLLEGE,HOSPITAL AND RESEARCH CENTRE |
| Address |
DEPARTMENT OF ANAESTHESIA , 5TH FLOOR ,HI-TECH BUILDING ,DR D.Y.PATIL MEDICAL COLLEGE , HOSPITAL AND RESEARCH CENTRE , SANT TUKARAM NAGAR, PIMPRI, PUNE
MAHARASHTRA 411018
INDIA
Pune
MAHARASHTRA
411018
India |
| Phone |
7799443222 |
| Fax |
|
| Email |
drbrindabadam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Bhavini Shah |
| Designation |
Professor , Department of Anaesthesiology |
| Affiliation |
DR D. Y. PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE , PIMPRI ,PUNE |
| Address |
DEPARTMENT OF ANAESTHESIA , 5TH FLOOR ,HI-TECH BUILDING ,DR D.Y.PATIL MEDICAL COLLEGE , HOSPITAL AND RESEARCH CENTRE , SANT TUKARAM NAGAR, PIMPRI, PUNE
MAHARASHTRA 411018
INDIA
Pune
MAHARASHTRA
411018
India |
| Phone |
9850829994 |
| Fax |
|
| Email |
drbhavinishah71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Bhavini Shah |
| Designation |
Professor , Department of Anaesthesiology |
| Affiliation |
DR D. Y. PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE , PIMPRI ,PUNE |
| Address |
DEPARTMENT OF ANAESTHESIA , 5TH FLOOR ,HI-TECH BUILDING ,DR D.Y.PATIL MEDICAL COLLEGE , HOSPITAL AND RESEARCH CENTRE , SANT TUKARAM NAGAR, PIMPRI, PUNE
MAHARASHTRA 411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9850829994 |
| Fax |
|
| Email |
drbhavinishah71@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy ,5th floor , Hi-tech building , DR.D.Y. Patil Medical College, Hospital and Research Center , Sant Tukaram Nagar , Pimpri , Pune , Maharashtra , India Pincode - 411018 |
|
|
Primary Sponsor
|
| Name |
Brinda Badam |
| Address |
Department of Anaesthesia , 5th Floor ,Hi-tech building ,Dr D.Y.Patil Medical College , Hospital and Research Centre , Sant Tukaram Nagar, Pimpri, Pune |
| Type of Sponsor |
Other [[SELF]] |
|
|
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 Brinda Badam |
DR.D.Y. Patil Medical College Hospital and Research Center |
Department of Anaesthesia , 5th Floor ,Hi-tech building ,Dr D.Y.Patil Medical College , Hospital and Research Centre , Sant Tukaram Nagar, Pimpri, Pune 411018
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
7799443222
drbrindabadam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS SUB-COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
normal saline, oxytocin |
normal saline I.V. followed by oxytocin 3U I.V bolus over 10 - 15 mins. |
| Comparator Agent |
phenylephrine , oxytocin |
phenylephrine 100 mcgs I.V. followed by oxytocin 3U I.V bolus over 10 - 15 minutes. |
| Intervention |
phenylephrine , oxytocin |
phenylephrine 75 mcgs I.V followed by oxytocin 3U I.V bolus over 10-15 mins. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
American Society of Anesthesiology (ASA) grade I and II,Singleton full term pregnant patients posted for caesarean section, Hemodynamically stable patients with all routine investigations within the normal limits and without any other co morbidities,Patients who give informed written consent and are willing to be a part of the study.
|
|
| ExclusionCriteria |
| Details |
unwilling female patients
female patients above ASA3
female patient with any contraindication for neuraxial blockade.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of concomitant administration of various doses of phenylephrine with oxytocin for prevention of oxytocin-induced hypotension following caesarian section under spinal anesthesia |
baseline vitals
every two minutes for first 10 minutes later every ten minutes till 70 minutes of procedure.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate Rescue vasopressor requirement
To observe the magnitude of hemodynamic changes
To study the incidence of side effects
To study the effect of phenylephrine coâ€administration on intraoperative blood loss |
baseline vitals
every two minutes for first 10 minutes later every ten minutes till 70 minutes of procedure.
|
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
03/02/2025 |
| 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="0"
Months="6"
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
|
It is a prospective , comparative , randomised ,double blinded study to compare the effects od coadministration of oxytocin with two doses of phenylephrine 75mcgs 100mcgs and NS respectively in patients divided into three groups and haemodynamic balance is observed mainly the incidence of oxytocin induced hypotension during cesarean section under spinal anaesthesia . |