- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01352130
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective, randomized, single blind study was conducted after our Institutional Review Board approved the study protocol, consent form and the randomization form. 70 consecutive ASA I-III patients (age18 to 60 years) undergoing breast surgery for carcinoma breast were included in the study after obtaining written informed consent. Patients refusing consent, with prolonged QTc interval, with arrhythmias or conduction defects and those with abnormal serum levels of potassium, calcium, magnesium were excluded. There was no standardized anaesthesia technique. The technique of induction of anaesthesia, maintenance and reversal of anaesthesia was left to the discretion of the staff anaesthetist in the operating theatre. The data on comorbidities, preoperative medications for the comorbidities, premedication, induction agents, analgesics, muscle relaxants and inhalation agents was collected.
Sample size calculation: A sample size calculation was performed [according to mean changes (difference of means) in QTc interval] to find out the number of patients needed to find a significant difference between the two drugs. To detect a QTc change from baseline of greater than 5 ms with α and β error of 0.05 and 0.20, respectively, and assuming an SD of QTc change of 10 ms using a one-sided test, a minimum of 35 subjects were needed in each antiemetic group.
Randomization: The patients (n= 70) were divided randomly in two groups by computer generated random numbers by the statisticians in the Clinical Research Secretariat (CRS) in our institute. Block randomization was done with blocks of 10, to allow stratification of the patients depending on whether they had received anthracycline based neoadjuvant chemotherapy. The list of randomization numbers and clinical details were maintained in the CRS.
Intervention: Once the patients arrived postoperatively in the recovery room, one of the investigators called the Clinical Research Secretariat (CRS) on phone, after completing the randomization form and gave the patient details. The Statistician allocated the drug the patient should receive which was prepared by the investigator which was either ondansetron 8 mg (Group O) or granisetron 1mg (Group G). A baseline 12 lead electrocardiogram was obtained before the drug was administered. After baseline ECG, patients in Group O were given intravenous 8 mg ondansetron and patients in group G were given 1 mg granisetron over 30 seconds. Subsequently serial 12 lead ECGs were done at 2 mins, 5 mins, 15mins, 1 hour and 2 hours. Pulse, blood pressure and SpO2 were also monitored at those intervals. Unfiltered Electrocardiograms were recorded at paper speed of 25mm/sec and at normal amplitude with a HP Vigilent Pagewriter 100TM device which automatically calculates and prints the heart rate and the duration of various ECG intervals. The investigators independently read and analyzed the ECG to confirm that the intervals obtained with the ECG machine were indeed accurate. QT and R-R intervals were measured for calculation of corrected QT (QTc) interval. The corrected QT (QTc) interval was calculated by using the formula described by Bezzet. [QTc = QT interval/√ (RR interval)]
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Maharashtra
-
Mumbai, Maharashtra, India, 400012
- TATA Memorial Hopsital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Ondansetron
Patients given Ondansetron
|
Intravenous Ondansetron 8 mgs
Other Names:
|
Active Comparator: Granisetron
Patients given Granisetron
|
Intravenous Granisetron 1 mgs
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of Granisetron and Ondansetron on QTc interval Prolongation at various time intervals after administration
Time Frame: 0 mins (before injection of study drug), 2 mins, 5 mins, 15mins, 1 hour and 2 hours
|
Both drugs are known to prolong QTc and other ECG intervals
|
0 mins (before injection of study drug), 2 mins, 5 mins, 15mins, 1 hour and 2 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Atul P Kulkarni, MD Anaes, Professor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Dermatologic Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin Antagonists
- Anti-Anxiety Agents
- Antipruritics
- Serotonin 5-HT3 Receptor Antagonists
- Granisetron
- Ondansetron
Other Study ID Numbers
- Akulkarni1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prolonged QTc Interval
-
EstetraCompleted
-
ApoPharmaCompletedProlonged QTc IntervalUnited States
-
Tris Pharma, Inc.Forest LaboratoriesCompletedProlonged QTc Interval | PharmacokineticUnited States
-
Grünenthal GmbHCompletedProlonged QTc Interval | PharmacokineticGermany
-
University Hospital, BordeauxAPHPCompleted
-
Asklepios Neurological Clinic Bad SalzhausenUniversity of GiessenCompleted
-
David Grant U.S. Air Force Medical CenterCompletedQTc IntervalUnited States
-
Chelsea TherapeuticsCompletedQTc IntervalUnited States
-
Usona InstituteCompletedPharmacokinetics | QTc IntervalUnited States
-
Teva Pharmaceuticals USAWithdrawn
Clinical Trials on Ondansetron
-
Merck Sharp & Dohme LLCCompletedChemotherapy-Induced Nausea and Vomiting
-
Seoul National University Bundang HospitalRecruiting
-
Tanta UniversityRecruitingCaesarean Section | Postoperative Nausea and Vomiting | Ondansetron LozengeEgypt
-
Halozyme TherapeuticsCompleted
-
Aquestive TherapeuticsCompleted
-
Washington University School of MedicineCompleted
-
General Hospital of Ningxia Medical UniversityCompleted
-
Merck Sharp & Dohme LLCCompletedChemotherapy-Induced Nausea and Vomiting