The efficacy of Ondansetron in reducing spinal anesthesia-induced hypotension using isobaric bupivacaine in elderly patient undergoing non-emergency surgery

The efficacy of Ondansetron in reducing spinal anesthesia-induced hypotension using isobaric bupivacaine in elderly patient undergoing non-emergency surgery : A prospective double blinded randomized controlled trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250227001

Enrollment

Registered

2025-02-27

Start date

2023-08-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Elderly patients undergoing non-emergency surgery under spinal anesthesia using isobaric bupivacaine. elderly patients, spinal anesthesia, hypotension, bupivacaine, ondansetron

Interventions

0.9% isotonic saline, 4 ml,Ondansetron 8 mg

Placebo Comparator Drug,Active Comparator Drug

Placebo,Ondansetron

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Elderly patients aged more than 65 years old 2. ASA classes II-III 3. Undergoing non-emergency surgery under spinal anesthesia with isobaric bupivacaine

Exclusion criteria

Exclusion criteria: 1. Contraindication to neuraxial anesthesia 2. Pre-existing of AV heart block, heart failure, arrhythmia, QTc prolongation 3. Allergic to local anesthetic agents, Ondansetron 4. Vasopressor was indicated before spinal anesthesia performed in any group 5. Patients with cognitive impairment who cannot make a decision by themselves 6. Surgery position: Trendelenburg, reverse Trendelenburg, sitting

Design outcomes

Primary

Measure	Time frame
Incidence of hypotension 0-30 minutes after spinal anesthesia MAP drop more than 20% from baseline, Need of vasopressor	—

Secondary

Measure	Time frame
Incidence of bradycardia 0-30 minutes after spinal anesthesia Heart rate below 50 bpm, Unstable bradycardia, Need of atropine	—

Countries

Thailand

Contacts

Public ContactTanatat Sukijsopone

Department of Anesthesiology, Faculty of Medicine, Khon Kaen University

tanatsu@kku.ac.th0830622935

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026