Effect of Palonosetron, Ondansetron and Dexamethasone in the Prevention of Postoperative Nausea and Vomiting

NCT05439798 | Unknown Phase 3

• 1 other identifier: farukcicekci6
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative nausea and vomiting (PONV) is an important outcome for the patient; patients generally rate PONV as worse than postoperative pain. The term PONV is typically used to describe nausea and/or vomiting or retching in the post-anesthetic care unit or within 24 hours postoperatively. Postoperative nausea and vomiting usually resolves or is treated without sequelae, but may require unexpected hospitalization and delay recovery room discharge. In the prophylaxis of PONV, ondansetron is one of the first widely used 5-HT3 receptor antagonists. Palonosetron, on the other hand, is a second generation 5-HT3 receptor antagonist with a half-life of 40 hours and higher receptor binding affinity. In addition, dexamethasone is another class of drugs that has emerged as a potentially useful prophylaxis for patients who are a corticosteroid and are at high risk of PONV with minimal side effects. However, a multimodal approach rather than antiemetic prophylaxis with a single pharmacological agent is described as a good way to reduce PONV, especially in high-risk cases. Conducted a previous systematic review and meta-analysis of the addition of dexamethasone to various 5-HT3 antagonists; however, it included only one study of palonosetron + dexamethasone. Since then, several meta-analyses have been performed on the efficacy of the combination of palonosetron and dexamethasone. This study was designed to find out the incidence of PONV by comparing the efficacy of the combination of palonosetron-dexamethasone, ondansetron-dexamethasone and dexamethasone alone for the prevention of PONV in patients undergoing pediatric laparoscopic surgery.

Conditions

Laparoscopic Surgery; Pediatrics; Nausea and Vomiting, Postoperative; Antiemetics; Therapeutic Use

Outcome Measures

Primary Outcomes (1)

• Incidence of palonosetron, ondansetron and dexamethasone in postoperative nausea and vomiting

  The primary endpoint of this study was to find the incidence of PONV among the three groups.

  72 hours

Secondary Outcomes (3)

• The time to first rescue antiemetic intake

  72 hours

• The total amount of antiemetic use

  72 hours

• The complications

  72 hours

Study Arms (3)

Group OD (Group ondansetron+dexamethasone)

ACTIVE COMPARATOR

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).

Drug: Ondansetron+Dexamethasone

Group PD (Group palonosetron+dexamethasone)

ACTIVE COMPARATOR

The patients in Group PD (Group palonosetron+dexamethasone) will be given intravenous (iv) palonosetron (0.75µg.kg-1) + dexamethasone (0.5 mg.kg-1).

Drug: Palonosetron+Dexamethasone

Group D (Group Dexamethasone)

PLACEBO COMPARATOR

The patients in Group D (Group Dexamethasone) will be given intravenous (iv) dexamethasone (0.5 mg.kg-1).

Drug: Dexamethasone

Interventions

Ondansetron+Dexamethasone DRUG

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)

Group OD (Group ondansetron+dexamethasone)

Palonosetron+Dexamethasone DRUG

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)

Group PD (Group palonosetron+dexamethasone)

Dexamethasone DRUG

Dexamethasone

Group D (Group Dexamethasone)

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) Class I-II,
• Between the ages of 7-18,
• Patients with written informed consent from themselves and their parents

You may not qualify if:

• 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

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University

Konya, 42250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: prospective, randomized, double-blind, controlled

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: June 30, 2022
• Study Start: June 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: May 31, 2023
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

TU (1)