- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05439798
Effect of Palonosetron, Ondansetron and Dexamethasone in the Prevention of Postoperative Nausea and Vomiting
Comparison of the Effects of Palonosetron + Dexamethazone, Ondansetron + Dexamethazone and Dexametazone Alone Against Postoperative Nausea and Vomiting in Pediatric Patients Undergoing Laparoscopic Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Konya, Turkey, 42250
- Selcuk University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) Class I-II,
- Between the ages of 7-18,
- Patients with written informed consent from themselves and their parents
Exclusion Criteria:
- Allergic to study drugs,
- Taking antiemetic drugs 24 hours before the operation,
- Gastroesophageal reflux disease,
- Body mass index (BMI) >35 kg/m 2,
- In the period of menstruation,
- Receiving cancer chemotherapy in the last four weeks,
- Allergy to NSAIDs,
- Patients with bronchial asthma
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group OD (Group ondansetron+dexamethasone)
The patients in Group OD (Group ondansetron+dexamethasone) will be given intravenous (iv) ondansetron (0.1 mg.kg-1) + dexamethasone (0.5 mg.kg-1).
|
The patients in Group OD (Group ondansetron+dexamethasone) will be given intravenous (iv) ondansetron (0.1 mg.kg-1) + dexamethasone (0.5 mg.kg) The patients in Group PD (Group palonosetron+dexamethasone) will be given intravenous (iv) palonosetron (0.75µg.kg-1) + dexamethasone (0.5 mg.kg-1). The patients In Group D (Group Dexamethasone) will be given iv only dexamethasone (0.5 mg.kg-1) |
Active Comparator: Group PD (Group palonosetron+dexamethasone)
The patients in Group PD (Group palonosetron+dexamethasone) will be given intravenous (iv) palonosetron (0.75µg.kg-1) + dexamethasone (0.5 mg.kg-1).
|
The patients in Group OD (Group ondansetron+dexamethasone) will be given intravenous (iv) ondansetron (0.1 mg.kg-1) + dexamethasone (0.5 mg.kg) The patients in Group PD (Group palonosetron+dexamethasone) will be given intravenous (iv) palonosetron (0.75µg.kg-1) + dexamethasone (0.5 mg.kg-1). The patients In Group D (Group Dexamethasone) will be given iv only dexamethasone (0.5 mg.kg-1) |
Placebo Comparator: Group D (Group Dexamethasone)
The patients in Group D (Group Dexamethasone) will be given intravenous (iv) dexamethasone (0.5 mg.kg-1).
|
Dexamethasone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of palonosetron, ondansetron and dexamethasone in postoperative nausea and vomiting
Time Frame: 72 hours
|
The primary endpoint of this study was to find the incidence of PONV among the three groups.
|
72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The time to first rescue antiemetic intake
Time Frame: 72 hours
|
The Secondary endpoints were the time to first rescue antiemetic intake
|
72 hours
|
The total amount of antiemetic use
Time Frame: 72 hours
|
the total amount of antiemetic use
|
72 hours
|
The complications
Time Frame: 72 hours
|
72 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Postoperative Nausea and Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Dermatologic Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin Antagonists
- Anti-Anxiety Agents
- Serotonin 5-HT3 Receptor Antagonists
- Antipruritics
- Dexamethasone
- Dexamethasone acetate
- BB 1101
- Palonosetron
- Ondansetron
Other Study ID Numbers
- farukcicekci6
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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