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To evaluate the effect of administration of ondansetron 8mg iv versus placebo before spinal anaesthesia in attenuation of post spinal hypotension in patients.

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 - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073900
Enrollment
174
Registered
2024-09-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium

Interventions

Intervention1: Ondansetron 8mg iv: To find out whether using ondansetron 8mg iv is effective in preventing incidence of hypotension following spinal anaesthesia by comparing with placebo of 10ml norma

Sponsors

Department of Anaesthesia Sawai Maan Singh College and Attached Hospital Jaipur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patient consenting to participate. 2.Adult patients 3.Patient belonging to ASA grade II.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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 groupsTimepoint: 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

MeasureTime frame
1.To observe side effects – if anyTimepoint: 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

Countries

India

Contacts

Public ContactDr Harshita Sharma

Sawai Man Singh Medical College and Attached Hospitals

rupihar@gmail.com9899785993

Outcome results

None listed

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