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To study the use of injection Ondensetron in preventing fall in Blood Pressure after Spinal Anaesthesia in women undergoing Caesarean delivery.

Efficacy of intravenous Ondensetron in Spinal induced Hypotension, in Parturients, undergoing Elective Caesarean section - A prospective Randomized, Double-blind and Placebo Controlled study. - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075907
Enrollment
140
Registered
2024-10-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O94- Sequelae of complication of pregnancy, childbirth, and the puerperium

Interventions

Intervention1: ONDANSETRON: ONDENSETRON, Dose-0.1mg/kg, Frequency- One dose, Route of administration - Intravenous, Total duration- 30mins Control Intervention1: PLACEBO: Placebo- NORMAL SALINE, Dose

Sponsors

Jonathan Joseph S L
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a. Age to 18 to 35 years b. American society of anesthesiologist physical status II c. Patient scheduled for cesarean section under spinal anesthesia d. Parturients with a singleton pregnancy at term ( 37 weeks of gestation or more )

Exclusion criteria

Exclusion criteria: a. Patients refusal b. Patients in whom spinal anesthesia is contraindicated c. Known allergy to ondansetron d. Long QT syndrome or another cause of prolonged QT e. Significant preexisting maternal disease( cardiovascular, cerebrovascular , coagulopathy , diabetes mellitus ) f. Pre existing or pregnancy induced hypertension . g. Pathological pregnancy ( ruptured membranes , pre eclampsia , placenta previa , gestational diabetes ) h. Body mass index 40 i. Fetal abnormalities

Design outcomes

Primary

MeasureTime frame
To study the efficacy of prophylactic ondansetron in reducing the incidence of hypotension after spinal anaesthesia .Timepoint: At Baseline

Secondary

MeasureTime frame
1.vasopressor consumption after prophylactic ondansetron 2. incidence of perioperative nausea & vomiting 3. incidence of perioperative shivering . Timepoint: Till 1 hour after surgery

Countries

India

Contacts

Public ContactDr Ekta rai

Christian Medical College

drektarai@Yahoo.Com9789250113

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026