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Clinical Trials/CTRI/2025/08/093209
CTRI/2025/08/093209
Not yet recruiting
Phase 4

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.

Department of anesthesiology TRIHMS1 site in 1 country180 target enrollmentStarted: September 1, 2025Last updated:

Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Department of anesthesiology TRIHMS
Enrollment
180
Locations
1
Primary Endpoint
To determine effect of different doses of ondansetron in reducing incidence of spinal anesthesia induced hypotension during cesarean section.

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 40.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • surgery under spinal anaesthesia.
  • elective lower section caesarian section.
  • ASA physical status II.

Exclusion Criteria

  • patient refusal
  • multiple pregnancy.
  • history of drug allergy
  • with history of cardiac disease.
  • presented with PIH and Gestational diabetes.

Outcomes

Primary Outcomes

To determine effect of different doses of ondansetron in reducing incidence of spinal anesthesia induced hypotension during cesarean section.

Time Frame: Baseline, every 5 minutes till closure of abdominal wound

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Department of anesthesiology TRIHMS
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Kenjom padu

Tomo riba institute of health and medical sciences

Study Sites (1)

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