| CTRI Number |
CTRI/2025/08/093209 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia Preventive |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Ondansetron on blood pressure during cesarean delivery under spinal anesthesia |
|
Scientific Title of Study
|
Comparison of the effect of different doses of ondansetron on spinal anesthesia induced hypotension in lower segment caesarean section: A double blinded randomized controlled study. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kenjom padu |
| Designation |
Post graduate trainees |
| Affiliation |
Tomo riba institute of health and medical sciences |
| Address |
Department of anesthesiology
Tomo riba institute of health and medical sciences. Naharlagun Naharlagun. Papumpare district. Arunachal pradesh. Papum Pare ARUNACHAL PRADESH 791110 India |
| Phone |
8414063922 |
| Fax |
|
| Email |
dr.kenzom@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dusu Lalin |
| Designation |
Assistant Professor |
| Affiliation |
Tomo riba institute of health and medical sciences |
| Address |
Department of anesthesiology
Tomo riba institute of health and medical sciences. Naharlagun Naharlagun. Papumpare district. Arunachal pradesh. Papum Pare ARUNACHAL PRADESH 791110 India |
| Phone |
7367967439 |
| Fax |
|
| Email |
drdusulalin@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Kenjom padu |
| Designation |
Post graduate trainees |
| Affiliation |
Tomo riba institute of health and medical sciences |
| Address |
Department of anesthesiology
Tomo riba institute of health and medical sciences. Naharlagun Naharlagun. Papumpare district. Arunachal pradesh. Papum Pare ARUNACHAL PRADESH 791110 India |
| Phone |
8414063922 |
| Fax |
|
| Email |
dr.kenzom@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of anesthesiology TRIHMS |
| Address |
department of anesthesiology 2nd floor block I, tomo riba institute of health and medical sciences, naharlagun |
| 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 kenjom padu |
Tomo Riba Institute of Health and Medical Sciences |
Department of Anesthesiology, Operation Theater, OT no. 5 2nd floor. BLOCK-I building. TRIHMS naharlagun, arunachal pradesh. Papum Pare ARUNACHAL PRADESH |
8414063922
dr.kenzom@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC TRIHMS |
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 |
| Intervention |
ondansetron 4mg |
4 mg ondansetron a selective serotonin antagonist diluted to 10 ml NS injected IV at the same time when spinal anesthesia is perform.
The effect on systolic blood pressure of participant will be recorded till start of anesthesia to closure of abdominal wound. |
| Comparator Agent |
Ondansetron 8mg |
8mg ondansetron will diluted to 10ml with ns and given intravenously at the time of spinal drug administration.
The effect on systolic blood pressure of participant will be recorded till start of anesthesia to closure of abdominal wound. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. surgery under spinal anaesthesia.
2. elective lower section caesarian section.
3. ASA physical status II |
|
| ExclusionCriteria |
| Details |
1. patient refusal
2. multiple pregnancy.
3. history of drug allergy
4. with history of cardiac disease.
5. presented with PIH and Gestational diabetes. |
|
|
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 |
| To determine effect of different doses of ondansetron in reducing incidence of spinal anesthesia induced hypotension during cesarean section. |
Baseline, every 5 minutes till closure of abdominal wound |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="180" Sample Size from India="180"
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)
|
01/09/2025 |
| 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
|
Subarachnoid block (spinal anesthesia) is the preferred
anesthetic technique for elective lower segment cesarean section (LSCS) due to
its rapid onset, reliability, and safety profile. However, it is frequently
associated with significant hemodynamic disturbances, primarily hypotension and
bradycardia, resulting from sympathetic blockade and decreased venous return. These changes can adversely affect both maternal and fetal outcomes by reducing
uteroplacental perfusion. Ondansetron, a selective 5-HT3 receptor
antagonist commonly used as an antiemetic, has been shown to modulate the
Bezold–Jarisch reflex-a vagally mediated cardiovascular reflex implicated in
spinal anesthesia-induced hypotension and bradycardia . Some studies suggest that intravenous ondansetron
administered prior to spinal anesthesia at different time interval has shown a
variable hemodynamic changes, reducing the incidence and severity of
hypotension and bradycardia in patients undergoing cesarean section. The
onset of sympathectomy after spinal anaesthesia and onset of intravenous
ondansetron are almost similar that is 1-5 minutes and its peak effect around
10-15 minutes. Therefore, we will be conducting study to assess
haemodynamic changes with simultaneous administration of intraveneous ondansetron
during subarachnoid block. |