| CTRI Number |
CTRI/2023/08/057012 [Registered on: 28/08/2023] Trial Registered Prospectively |
| Last Modified On: |
22/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of two different doses of drug known to prevent fall in blood pressure(ondansetron) in caesarean delivery by calculating the dose of injection of blood pressure raising medicine(ephedrine) required to control fall in blood pressure. |
|
Scientific Title of Study
|
Prospective randomised double blinded interventional study to compare the dose of ephedrine required to control hypotension in patients receiving two different doses of ondansetron during elective caesarean section under spinal anaesthesia :At SMS Medical College, Jaipur |
| 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 Harpreet Kaur |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College and attached Hospitals, Jaipur |
| Address |
Department of Anaesthesiology, SMS Medical College and attached Hospitals, Adarsh Nagar ,Jaipur Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9899785993 |
| Fax |
|
| Email |
rupihar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harpreet Kaur |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College and attached Hospitals, Jaipur |
| Address |
Department of Anaesthesiology, SMS Medical College and attached Hospitals, Adarsh Nagar ,Jaipur Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9899785993 |
| Fax |
|
| Email |
rupihar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhu |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical College and attached Hospitals, Jaipur |
| Address |
Department of Anaesthesiology, SMS Medical College and attached Hospitals Adarsh Nagar ,Jaipur Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
8708501448 |
| Fax |
|
| Email |
madhuahlawat71096@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, SMS Medical College and attached Hospitals, Jaipur |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology, SMS Medical College and attached Hospitals, Jaipur |
| Address |
JLN Marg, Adarsh Nagar, Jaipur |
| Type of Sponsor |
Government medical college |
|
|
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 Harpreet Kaur |
Pandit Deen Dayal Upadhyaya Hospital,Jaipur |
Pandit Deen Dayal Upadhyaya Hospital, Gangori Bazar Road, Gangori Bazar,(Hospital attached to SMS Medical College Jaipur) Jaipur
Jaipur
RAJASTHAN |
9899785993
rupihar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Ethics Committee,SMS Medical College and attached Hospitals,Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, (2) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Calculating the dose of ephedrine required to control the hypotension in patients receiving two different doses of intravenous ondansetron during lower segment caesarean section under spinal anaesthesia. |
Calculating the dose of ephedrine required to control hypotension in patients receiving 4mg intravenous ondansetron versus 8mg intravenous ondansetron given 5minutes before spinal anaesthesia during lower segment caesarean section. |
| Comparator Agent |
Effect of 4mg intravenous injection given 5 minutes before spinal anaesthesia. |
Calculation of total dose of ephedrine required to control hypotension in patients receiving 4mg of intravenous ondansetron given 5 minutes before spinal anaesthesia during lower segment caesarean section. |
| Comparator Agent |
Effect of 8mg intravenous injection given 5 minutes before spinal anaesthesia. |
Calculation of total dose of ephedrine required to control hypotension in patients receiving 8mg of intravenous ondansetron given 5 minutes before spinal anaesthesia during lower segment caesarean section. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1) Patients undergoing elective caesarean section.
2) Age between 18-35 years.
3) Patients belonging to American Society Of Anaesthesiologist(ASA) grade II.
4) Patients consenting to participate. |
|
| ExclusionCriteria |
| Details |
1)History of pre eclampsia and eclampsia.
2)Obesity
3)Patients with allergy to drugs used in the study.
4)Patients with contraindication to neuraxial anaesthesia.
5)Patients with history of drug abuse or addictions. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To determine the difference in total dose of ephedrine required to control hypotension between two different doses of intravenous ondansetron in parturients undergoing elective lower segment caesarean section .
2)To determine the difference in proportion of hypotension between two different doses of intravenous ondansetron in parturients undergoing elective lower segment caesarean section. |
Baseline
00 minutes(after spinal)
01 minutes
02 minutes
03 minutes
05 minutes
10 minutes
15 minutes
20 minutes
25 minutes
30 minutes
40 minutes
50 minutes
60 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine side effects between both groups -Nausea, Vomiting, shivering, bradycardia |
The application of spinal anaesthesia till completion of surgery. |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
04/09/2023 |
| 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="0"
Months="4"
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
|
The aim of this study is to compare the efficacy of two different dose of intravenous ondansetron in preventing the hypotension after spinal anaesthesia by calculating the total dose of ephedrine required to control hypotension in patients undergoing elective caesarean section. In this study two different doses of intravenous ondansetron 4mg and 8mg will be given 5 minutes before spinal anaesthesia . Total dose of ephedrine required to control hypotension will be calculated in both groups. This will help us to know the effective dose of ondansetron to prevent hypotension in LSCS cases under spinal anaesthesia. |