Clinical trial · Interventional
Granisetron Versus Ondansetron: Comparative Effects on ECG, QTc
Comparative Electrocardiographic Effects of Intravenous Ondansetron and Granisetron in Patients Undergoing Surgery for Carcinoma Breast: A Prospective Single Blind Randomised Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Postoperative nausea and vomiting \[PONV\] are common and distressing symptoms after surgery performed under general anaesthesia. 5HT3 antagonists are routinely used for prevention as well as treatment of PONV. After IRB approval we compared the effects of ondansetron and granisetron on the various intervals on ECG in 70 patients undergoing elective surgery for carcinoma breast after written informed consent. The demographic data was collected. The administration of the anaesthetic was left to the discretion of the operating room staff specialist. In the Postoperative Recovery Room patients were randomised to receive 8 mgs of ondansetron or 1 mg of granisetron intravenously. Serial ECGs were recorded at 0 mins (before injection of study drug), 2 mins, 5 mins, 15mins, 1 hour and 2 hours. Pulse rate, Non-invasive blood pressure and SpO2 were also recorded. T
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prolonged QTc Interval | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Granisetron | Drug | — | UNRESOLVED |
| Ondansetron | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Ondansetron
- description
- Patients given Ondansetron
- interventionNames
- Drug: Ondansetron
- type
- ACTIVE_COMPARATOR
- label
- Granisetron
- description
- Patients given Granisetron
- interventionNames
- Drug: Granisetron
Primary outcomes (1)
- measure
- Effect of Granisetron and Ondansetron on QTc interval Prolongation at various time intervals after administration
- timeFrame
- 0 mins (before injection of study drug), 2 mins, 5 mins, 15mins, 1 hour and 2 hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * All patients undergoing breast surgery for carcinoma breast. * Patients between ages 18 to 60 years. * ASA I \\ II \\ III * Patients weight between 40 and 70 kilograms. Exclusion Criteria: * Patient refusing consent * Prophylactic anti emetic drug administration during intraoperative period * Known case of prolonged QTc interval * Known case decompensated cardiomyopathy * Known case of cardiac arrhythmia or bundle branch block * Case of congestive heart failure with left ventricular ejection fraction \<40% * Abnormal serum level of potassium, calcium, magnesium
References
Publications (1)
- DERIVEDGanjare A, Kulkarni AP. Comparative electrocardiographic effects of intravenous ondansetron and granisetron in patients undergoing surgery for carcinoma breast: A prospective single-blind randomised trial. Indian J Anaesth. 2013 Jan;57(1):41-5. doi: 10.4103/0019-5049.108560. PMID 23716765