Palonosetron vs Combination of Granisetron and Dexamethasone in Preventing PONV in Laparoscopic Cholecystectomy.
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ClinicalTrials.gov Identifier: NCT06043336 |
Recruitment Status :
Completed
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
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This is a prospective, randomized, double-blinded study comparing the post-operative nausea vomiting (PONV) profile following administration of intraoperative palonosetron alone and the combination of granisetron and dexamethasone in moderate to high-risk patients undergoing elective laparoscopic cholecystectomy.
Patients aged 18-65 years with American Society of Anesthesiologists physical status I or II were randomized into two groups. Group A received 1 ml of intravenous (IV) 0.9% saline after intubation and IV palonosetron 0.075 mg at the end of operation. Group B received IV dexamethasone 4 mg after intubation and IV granisetron 1 mg at the end of surgery. The occurrence of PONV and the need for rescue antiemetics were assessed at 30 minutes, 4, 24 and 48 hours post-anesthesia. A complete response towards the study drugs was considered when patients did not experience PONV and did not require rescue antiemetics. The side effects of the study drugs were evaluated. Patient satisfaction with the anti-emetics administered was assessed.
These parameters were compared between Group A and Group B: the occurrence of PONV, the need of rescue antiemetics, the side effects of the study drugs and patient satisfaction with the anti-emetics administered.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postoperative Nausea and Vomiting | Drug: Dexamethasone, granisetron & palonosetron | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 134 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Care Provider) |
Primary Purpose: | Prevention |
Official Title: | A Comparative Study Between Palonosetron vs the Combination of Granisetron and Dexamethasone in Preventing Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy. |
Actual Study Start Date : | May 10, 2018 |
Actual Primary Completion Date : | May 10, 2019 |
Actual Study Completion Date : | May 10, 2019 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Group B
Group B received intravenous (IV) dexamethasone 4 mg after intubation & IV granisetron 1 mg at the end of surgery
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Drug: Dexamethasone, granisetron & palonosetron
. Group A received 1 ml of intravenous (IV) 0.9% saline after intubation and IV palonosetron 0.075 mg at the end of operation. Group B received IV dexamethasone 4 mg after intubation and IV granisetron 1 mg at the end of surgery |
Experimental: Group A
Group A received 1 ml of intravenous (IV) 0.9% saline after intubation and IV palonosetron 0.075 mg at the end of operation.
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Drug: Dexamethasone, granisetron & palonosetron
. Group A received 1 ml of intravenous (IV) 0.9% saline after intubation and IV palonosetron 0.075 mg at the end of operation. Group B received IV dexamethasone 4 mg after intubation and IV granisetron 1 mg at the end of surgery |
- Complete response towards the study drugs [ Time Frame: 1 year ]Number of patients who did not experience postoperative vomiting, did not experience postoperative nausea & did not require rescue antiemetics.
- The side effects of the study drugs [ Time Frame: 1 year ]Number of patients who developed side effects after receiving the study drugs
- Patient satisfaction with the anti-emetics administered [ Time Frame: 1 year ]Number of patients who satisfied with the anti-emetics administered
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- aged 18 to 65 years old
- American Society of Anesthesiologists (ASA) physical status I or II
- scheduled for elective laparoscopic cholecystectomy under general anesthesia
Exclusion Criteria:
- patients with heart diseases
- patients with prolonged QT syndrome
- patients with a family history of sudden death
- patients with known allergies to dexamethasone, granisetron & palonosetron
- patients with contraindications to dexamethasone, granisetron & palonosetron
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06043336
Malaysia | |
Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia | |
Cheras, Kuala Lumpur, Malaysia, 56000 |
Principal Investigator: | Maryam Budiman, M.D. | Faculty of Medicine, Universiti Kebangsaan Malaysia |
Responsible Party: | Universiti Kebangsaan Malaysia Medical Centre |
ClinicalTrials.gov Identifier: | NCT06043336 |
Other Study ID Numbers: |
FF-2018-209 Fundamental data ( Other Identifier: Faculty of Medicine, Universiti Kebangsaan Malaysia ) |
First Posted: | September 21, 2023 Key Record Dates |
Last Update Posted: | September 21, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Nausea Vomiting Postoperative Nausea and Vomiting Signs and Symptoms, Digestive Postoperative Complications Pathologic Processes Dexamethasone Palonosetron Granisetron Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Serotonin 5-HT3 Receptor Antagonists Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |