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

NCT ID: NCT05439798

Last Updated: 2022-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-05-31

Brief Summary

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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.

Detailed Description

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This study will be conducted with the data to be obtained from the Anesthesiology Surgery Form and Pediatric Surgery Service Forms in 66 patients aged 7-18 years, after the approval of Local Ethics Committee, Faculty of Medicine, Selcuk University. The patıents will be randomized ınto 3 groups. Patients in Group OD (n = 22) (Group ondansetron+dexamethasone) will be given intravenous (iv) ondansetron (0.1 mg.kg-1) + dexamethasone (0.5 mg.kg-1). For this group of patients, ondansetron (0.1 mg.kg-1) (5 ml) will be prepared and will be named No: 1. It will be administered at the 8th and 16th hours postoperatively. In Group PD (n = 22) (Group palonosetron+dexamethasone), patients will be given intravenous (iv) palonosetron (0.75µg.kg-1) + dexamethasone (0.5 mg.kg-1). In Group D (n = 22) (Group Dexamethasone) iv only dexamethasone (0.5 mg.kg-1) will be given. For the patients in Group PD and Group D, normal saline (SF) (5 ml solution) will be prepared for intravenous administration and will be named No: 2 and 3, respectively, and will be administered again at the 8th and 16th hours. The reason why we give SF here is to provide drug blanking, but not to give active drug, since the half-life of palonasetron and dexamethasone is long, up to 36 hours. The files of the patients will be examined and demographic data. For the primary purpose of this study, PONV values will be evaluated at 2, 6, 12, 24, 48, and 72 hours postoperatively. The intensity of nausea (0 = no nausea, 10 = worst possible nausea) will be rated on a verbal numerical rating scale (VNRS). The severity of nausea and vomiting will be classified as mild (1-3), moderate (4-6) and severe (7-10) according to VNRS scores. Secondary endpoints, time of taking first rescue antiemetic and total dose of rescue antiemetic, and complications (dizziness, headache, and arrhythmia) will be recorded.

Conditions

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Laparoscopic Surgery Pediatrics Nausea and Vomiting, Postoperative Antiemetics Therapeutic Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective, randomized, double-blind, controlled
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Ondansetron+Dexamethasone

Intervention Type 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)

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

Group Type ACTIVE_COMPARATOR

Palonosetron+Dexamethasone

Intervention Type 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 D (Group Dexamethasone)

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

Group Type PLACEBO_COMPARATOR

Dexamethasone

Intervention Type DRUG

Dexamethasone

Interventions

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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) 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)

Intervention Type DRUG

Palonosetron+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) 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)

Intervention Type DRUG

Dexamethasone

Dexamethasone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Selcuk University

OTHER

Sponsor Role lead

Responsible Party

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Faruk Cicekci

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Selcuk University

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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farukcicekci6

Identifier Type: -

Identifier Source: org_study_id