A Study for evaluating the effectiveness of Ondansetron in Preventing Hypotension During Lower Limb Surgery under Spinal Anesthesia

TO EVALUATE THE ROLE OF PROPHYLACTIC INTRAVENOUS ONDANSETRON IN PREVENTING HYPOTENSION IN PATIENTS UNDERGOING LOWER LIMB SURGERY UNDER SPINAL ANAESTHESIA A RANDOMISED CONTROLLED STUDY - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/081714

Enrollment

112

Registered

2025-03-05

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: M959- Acquired deformity of musculoskeletal system, unspecified

Interventions

Intervention1: Ondansetron: It is the prototype of a distinct class of antiemetic drugs developed to control cancer chemotherapy/radiotherapy induced vomiting, and later found to be highly effective i

Eligibility

Inclusion criteria

Inclusion criteria: Of ASA physical status 1 or 2 scheduled for elective lower limb surgery

Exclusion criteria

Exclusion criteria: Patients Refusal Contraindications to spinal Anaesthesia Patient allergic to Ondansetron Patients on selective serotonin reuptake inhibitors pregnancy morbid obesity Qt prolongation in ECG

Design outcomes

Primary

Measure	Time frame
To compare the incidence of hypotension in both the study groups.Timepoint: Baseline 3 minutes ,6 minutes, 9 minutes,12 minutes,15 minutes,18 minutes ,21 minutes,24 minutes, 27 minutes and 30 minutes after spinal	—

Secondary

Measure	Time frame
To assess the effect of ondansetron on heart rate after spinal anaesthesia. To assess any complications arising during the course of the study. Timepoint: Preparatory phase 02 months Phase of data collection 06 months Phase of analysis 02 months Report writing & submission 02 months	—

Countries

India

Contacts

Public ContactNimisha Bansal

ESI-PGIMSR, esic medical college , Joka

dranilthakur@gmail.com9350103337

Outcome results

None listed

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