| CTRI Number |
CTRI/2026/02/103069 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Can Oxytocin Given Before a Planned C-Section Help Prevent Excessive changes in blood pressure and heart rate |
|
Scientific Title of Study
|
EFFECT OF PREOPERTAIVE OXYTOCIN INFUSION AMONG WOMEN UNDERGOING CAESAREAN SECTION :A RANDOMISED CLINICAL STUDY |
| Trial Acronym |
RANDOMISED CLINICAL STUDY |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR RAHUL SINGH THAKUR |
| Designation |
RESIDENT PG DOCTOR |
| Affiliation |
BLDES SHRI BM PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
3rd floor OT COMPLEX,DEPT OF ANAESTHESIA,bangaramma sajjan campus,blde
Bijapur
KARNATAKA
586103
India |
| Phone |
9148303790 |
| Fax |
|
| Email |
rahul.ss2017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BASAVARAJ PATIL MD |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
BLDES SHRI BM PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
3 rd floor OT complex,department of anesthesia,bangaramma sajjan campus,blde
Bijapur
KARNATAKA
586103
India |
| Phone |
7829655342 |
| Fax |
|
| Email |
drbnp2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR BASAVARAJ PATIL MD |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
BLDES SHRI BM PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
3 rd floor ot complex,department of anesthesia,bangaramma sajjan campus,blde
Bijapur
KARNATAKA
586103
India |
| Phone |
7829655342 |
| Fax |
|
| Email |
drbnp2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDES DEEMED TO BE UNIVERSITY SHRI BM PATIL MEDICAL COLLEGE ,HOSPITAL AND RESEARCH CENTRE,INDIA,KARNTAKA VIJAYAPURA 586103 |
|
|
Primary Sponsor
|
| Name |
BLDES BM PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE VIJAYAPURA |
| Address |
3 rd floor OT complex,department of anesthesia,bangaramma sajjan campus,blde |
| 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 |
| Drbasavaraj patil |
BLDES SHRI BM PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
3 rd floor OT complex,department of anesthesia,bangaramma sajjan campus,blde,586103
Bijapur
KARNATAKA |
7829655342
drbnp2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BLDE DU IEC SBMPMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
pregnancy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
giving preload to comparative agents with only normal saline |
patients will receive preloading with 500ml of 0.9% normal saline before spinal anaesthesia ,after delivery 5IU oxytocin will be administered IV over 5 minutes ,NS will be given via dial flow metre to mimic the oxytocin setup used in intervention group |
| Intervention |
preoperative oxytocin infusion in women undergoing elective caesarean section |
patient will receive preoperative oxytocin infusion at rate 6 milli IU /minute
T 1 -before spinal anaesthesia continue till skin closure ,oxytocin will be prepared as 3IU in 500ml NS administered 40ml/hr using dial flow metre |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
41.00 Year(s) |
| Gender |
Female |
| Details |
singleton pregnancy
undergoing elective caesarean section under spinal anaesthesia
ASA physical status 1&2 |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the hemodynamic effect of preoperative oxytocin infusion on hemodynamic parameters during elective caesarean section under spinal anaesthesia |
patient will receive preoperative oxytocin infusion at rate 6 milli IU /minute
T 1 -before spinal anaesthesia continue till skin closure ,oxytocin will be prepared as 3IU in 500ml NS administered 40ml/hr using dial flow metre |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare vasopressor usage & use of oxytocin |
patient will receive preoperative oxytocin infusion at rate 6 milli IU /minute
T 1 -before spinal anaesthesia continue till skin closure ,oxytocin will be prepared as 3IU in 500ml NS administered 40ml/hr using dial flow metre |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
16/02/2026 |
| 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="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
|
preoperative oxytocin infusion in women undergoing elective caesarean section with 3 units of oxytocin in 500ml Normal saline start infusion at the rate of 40ml/HR from start of skin incision till complete of procedure to check the hemodynamic stability of the patient after starting oxytocin and and check the usage of vasopressors that is mephentremine and check for the fall in blood pressure if there is severe fall in blood pressure than give mephentremine and calculate the dosage given and oxytocin to be given accordingly if the uterus is not contracted and post op 10 units of oxytocin to be added in 500ml after skin closure the aim is to maintain the hemodynamic stability with starting preoperative oxytocin |