Granisetron Versus Ondansetron: Comparative Effects on ECG, QTc

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tata Memorial Hospital
• Treatments: Granisetron; Ondansetron; Serotonin 5-HT3 Receptor Antagonists

Criteria

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