| CTRI Number |
CTRI/2024/09/073900 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To evaluate the effect of administration of ondansetron 8mg iv versus placebo before spinal anaesthesia in attenuation of post spinal hypotension in patients. |
|
Scientific Title of Study
|
A Prospective Randomised Double Blind interventional Comparative study of
administration of Ondansetron 8mg intravenous versus placebo before Spinal Anaesthesia in attenuation of post Spinal Hypotention 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 |
Sawai Man Singh Medical College and Attached Hospitals |
| Address |
Department of Anaesthesia, Sawai Man Singh Medical College and Attached Hospitals
JLN Marg Jaipur 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 |
Sawai Man Singh Medical College and Attached Hospitals |
| Address |
Department of Anaesthesia, Sawai Man Singh Medical College and Attached Hospitals
JLN Marg Jaipur
RAJASTHAN 302004 India |
| Phone |
9899785993 |
| Fax |
|
| Email |
rupihar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Harshita Sharma |
| Designation |
Resident Doctor |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospitals |
| Address |
Department of Anaesthesia, Sawai Man Singh Medical College and Attached Hospitals JLN Marg Jaipur Jaipur RAJASTHAN 302004 India |
| Phone |
7014618974 |
| Fax |
|
| Email |
sas.akum111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia Sawai Maan Singh Medical College and Attached Hospital Jaipur |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia Sawai Maan Singh College and Attached Hospital Jaipur |
| Address |
Department of Anaesthesia Sawai Maan Singh College and Attached Hospital Jaipur Rajasthan 302004 |
| 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 |
Sawai Man Singh Medical College and attached Hospitals |
Obstetrics and Gynecology Operation Theatre, Department of Anaesthesiology Sawai Man Singh Medical College and attached hospitals, 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 MEDICALCOLLEGE AND ATTACHED HOSPITALS JAIPUR |
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 |
Inj.10ml Normal saline given 5 min.before spinal anaesthesia |
Comparison of haemodynamic factors with the intervention group . |
| Intervention |
Intravenous Inj Ondansetron 8mg 5 minutes before giving spinal anaesthesia. |
Comparison of haemodynamic factors (blood pressure,heart rate ,mean arterial pressuure ,Sp02)with placebo of 10ml inj.normal saline |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Patient consenting to participate.
2.Adult patients
3.Patient belonging to ASA grade II. |
|
| ExclusionCriteria |
| Details |
1.Patients with contraindication to neuraxial anaesthesia.
2.Patient with history of drug abuse or addictions.
3.SA converted to general anaesthesia.
4.Allergy to ondansetron or local anaesthetic contraindication to regional anaesthesia and on medications which acts on the 5HT3 receptors were excluded from the study.
|
|
|
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 fall of systolic blood pressure SBP (in mm Hg), diastolic pressure (DBP in mm Hg), mean arterial pressure(MAP) and heart rate (HR) between both groups.
2.To determine difference in dose of ephedrine requirement in (mg) in both groups |
PRE OP
00 (after spinal)
01 min
02 min
03 min
05 min
10 min
15 min
20 min
25 min
30 min
40 min
50 min
60 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To observe side effects – if any |
PRE OP
00 (after spinal)
01 min
02 min
03 min
05 min
10 min
15 min
20 min
25 min
30 min
40 min
50 min
60 min |
|
|
Target Sample Size
|
Total Sample Size="174" Sample Size from India="174"
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)
|
20/09/2024 |
| 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="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 seen in as many as 50% of the parturients undergoing lower segment caesarean section (LSCS) under spinal anaesthesia. Hypotension due to spinal anaesthesia is mainly caused by sympathetic blockade . In obstetric patients spinal anaesthesia induced hypotension is further aggravated due to aortocaval compression by gravid uterus. Many techniques such as lower legs compression, uterine displacement, using vasopressor and administering fluids has shown a decrease in incidence of hypotension. In this study, we plan to study and compare the effect of 8mg intravenous (IV) ondansetron and placebo given prophylactically 5 minutes (min.) before spinal anaesthesia on incidence of hypotension in patients undergoing elective caesarean section. For this study a total of 174 patients (n=174) undergoing elective caesarean section who satisfy the inclusion criteria will be randomly divided into two groups of 87 each (n=87) (A and B),Group A will receive 8mg of IV ondansetron and group B will receive placebo 5min. before spinal anaesthesia . When patient arrives in the operating room (OR), IV cannula will be inserted and haemodynamic variables will be measured. After this patient will receive 4mg of IV ondansetron (Group A) and 8mg of IV ondansetron 5min. before spinal anaesthesia. After this spinal anaesthesia will be administered. Patient will be put in supine position immediately. Surgery will be allowed to proceed after the block reaches T6 sensory level (complete sensory block). Quantitative values of ephedrine use (mg) and IV crystalloids (L) will be recorded. Haemodynamic parameters including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), pulse rate (PR), oxygen saturation (SPO2), and respiratory rate (RR) will be recorded preoperatively and intraoperatively. The data will be collected in a prescribed proforma and statistically analysed. |