| CTRI Number |
CTRI/2023/08/056746 [Registered on: 22/08/2023] Trial Registered Prospectively |
| Last Modified On: |
14/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To analyse the effect of prophylactic combination of Glycopyrrolate, Ondansetron and Ephedrine in minimizing hypotension during obstetric spinal anaesthesia. |
|
Scientific Title of Study
|
A comparative study to assess the efficacy of combination of Glycopyrrolate, Ondansetron and Ephedrine in prevention of hypotension following obstetric spinal anaesthsia in terms of need for therapeutic dose of Ephedrine- a randomized, double blind, controlled study in Department of Anaesthesiology, 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 Chandra Shekhar Chatterjee |
| Designation |
Seniour Professor |
| Affiliation |
Sawai Man Singh Medical College Jaipur |
| Address |
Department Of Anaesthesiology Second Floor Dhanvantri Complex
S M S Medical College Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9828088092 |
| Fax |
|
| Email |
chatterjee.chandrashekhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandra Shekhar Chatterjee |
| Designation |
Seniour Professor |
| Affiliation |
Sawai Man Singh Medical College Jaipur |
| Address |
Department Of Anaesthesiology Second Floor Dhanvantri Complex
S M S Medical College Jaipur
RAJASTHAN
302004
India |
| Phone |
9828088092 |
| Fax |
|
| Email |
chatterjee.chandrashekhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tontanga Momoson Maring |
| Designation |
Juniour Resident |
| Affiliation |
Sawai Man Singh Medical College Jaipur |
| Address |
Department Of Anaesthesiology Second Floor Dhanvantri Complex
S M S Medical College Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9572615336 |
| Fax |
|
| Email |
momoson.tontanga@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology Second Floor Dhanvantri Complex S M S Medical College
Jaipur |
|
|
Primary Sponsor
|
| Name |
Sawai Man Singh Medical College Jaipur |
| Address |
Department Of Anaesthesiology Second Floor Dhanvantri Complex
S M S Medical College 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 Chandra Shekhar Chatterjee |
Sawai Man Singh Medical College and Attached Hospitals |
Department Of Anaesthesiology
Second Floor Dhanvantri Complex S M S Medical College
Jaipur
Jaipur
RAJASTHAN |
9828088092
chatterjee.chandrashekhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S M S Medical College Ethics Committee |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal Saline placebo |
injection Normal Saline bolus as placebo of Glycopyrrolate, Ondansetron and infusion of Normal Saline as a placebo of Ephedrine infusion with a separate line. |
| Intervention |
Prophylactic injection prior to spinal anaesthesia |
Injection Glycopyrrolate 200 micrograms, Injection Ondansetron 4 milligrams and Infusion Ephedrine 1 milligram per minute before giving spinal anaesthesia with Injection 0.5 percent Bupivacaine 2 millilitre |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Parturients aged 20-35 years.
2. parturients belong to ASA Grade I and II
3. Parturients undergoing elective caeserean section under spinal anaesthesia.
4. Parturients willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Parturients with contraindications to spinal anaesthesia.
2. Parturients with history of allergy to study drugs.
3. Parturients with pregnancy induced hypertention
4. Parturients with multiple gestations and abnormal placentation.
5. Parturients with height less than 145cm
|
|
|
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 |
1. Mean total dose of ephedrine required intra operatively in both the groups.
2. Mean number of hypotension episodes between the period of induction & delivery of baby in both the groups.
3. Mean number of bradycardia episodes in intra operative period in both the groups.
|
90 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Neonatal APGAR scores at 0 & 3min.
2. Delivery time in both the groups.
3. Adverse events in both the groups, if any. |
90 minutes |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
25/08/2023 |
| 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="5"
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
|
Hypotension is one of the major complications following spinal anaesthesia in caeserean sections which may compromise the well-being of both the mother and the newborn. Our aim is to find out whether prophylactic combination of Glycopyrrolate, Ondansetron and Ephedrine is effective in minimizing hypotension following obstetric spinal anaesthesia |