Compare Between Two Doses of Palonosetron on the Prevention of Postoperative Nausea and Vomiting in Obese Patients

NCT02941913 | Completed Phase 4 DMC

• 1 other identifier: 55695816.7.0000.5274
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND: Palonosetron is a second generation serotonin antagonist usually used in a fixed dose of 75 mcg for the prophylaxis of postoperative nausea and vomiting. Although there are a few trials evaluating bodyweight-adjusted doses of palonosetron, the ideal dose for obese patients has not yet been investigated. The aim of this study is to evaluate if the use of bodyweight-adjusted doses of palonosetron (1mcg / kg) is more effective than a fixed dose (75mcg) on preventing postoperative nausea and vomiting in female patients with a body mass index equal to or above 30 kg /m2 whom have undergone breast surgery METHODS: A prospective, randomized double-blind trial will be conducted at the National Cancer Institute (INCA - HCIII), in Rio de Janeiro, Brazil. Eligible patients are female aged between 18-70 years of age with an ASA physical status of one to three, with body mass index equal to or greater than 30 kg / m2, scheduled to undergo elective breast surgery. Forty patients will be randomized to receive a fix dose of 75 μg of palonosetron (group I - GI) and 40 patients will receive a bodyweight-adjusted dose of 1mcg/kg of palonosetron (group II - GII). Patients will be assessed over 3 time periods: 0-6 h, 6-26 h and 24-48 h after surgery. After discharge, all patients will be contacted by telephone at regular intervals to record the episodes of nausea and vomiting as well as analgesic and antiemetic requirements. The primary outcome measure will include the number of emetic episodes, the incidence of nausea, the need for rescue antiemetics and the analgesic requirement over 48h. The secondary outcome will be to evaluate the frequency of polymorphism of the 5-HT3 receptors and their correlation with the antiemetic effect and adverse effects.

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (5)

• episodes of nausea and vomiting

  To determine the frequency of individual episodes of nausea and vomiting in the periods of 6 hours postoperatively

  hour 6 after surgery

• episodes of nausea and vomiting

  To determine the frequency of individual episodes of nausea and vomiting in the period of 24 hours postoperatively

  hour 24 after surgery

• number of patients who need antiemetic rescue medication

  Compare need of antiemetic rescue medication during the periods of 48 hours postoperatively

  hour 48 after surgery

• complete antiemetic response

  Determine the number of patients who had complete antiemetic response (absence of nausea, vomiting and need for rescue medication)

  hour 48 after surgery

• episodes of nausea and vomiting

  To determine the frequency of individual episodes of nausea and vomiting in the periods of 48 hours postoperatively

  hour 48 after surgery

Secondary Outcomes (1)

• polymorphism of the 5-HT3 receptors

  6 months

Study Arms (2)

Fixed Dose Palonosetron group

EXPERIMENTAL

patient will receive a fix dose of 75 μg of palonosetron

Drug: palonosetron

Bodyweight-adjusted Dose Palonosetron

EXPERIMENTAL

patient will receive a bodyweight-adjusted dose of 1mcg/kg of palonosetron

Drug: palonosetron

Interventions

palonosetron DRUG

receive a fix dose of 75 μg of palonosetron (group I - GI) and another forty patients will receive a bodyweight-adjusted dose of 1mcg/kg of palonosetron (group II - GII).

Also known as: onicit

Bodyweight-adjusted Dose Palonosetron; Fixed Dose Palonosetron group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female
• aged 18-70 years
• ASA physical status of one to three
• body mass index equal to or greater than 30 kg / m2
• scheduled to undergo elective breast surgery

You may not qualify if:

• patients who had received chemotherapy within 4 weeks,
• patients who have undergone emergency surgery,
• history of vomiting within 24 hours;
• hypersensitivity to other 5-HTantagonists,
• patients who received any antiemetic, corticosteroid, or other drug with antiemetic effect,
• smokers
• history of alcoholism.

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead

Study Sites (1)

National Cancer Institute (INCA - HCIII)

Rio de Janeiro, 20560-120, Brazil

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Palonosetron

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• nathalia ferreira, MDanesthesia

  anesthesiologist

  PRINCIPAL INVESTIGATOR

• Nubia Verçosa Figueiredo, professor

  Professor of Department of Anesthesiology of Federal University of Rio de Janeiro

  STUDY DIRECTOR

• Ismar Lima Cavalcanti, professor

  Professor of Department of Anesthesiology of Federal Fluminense University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist. MSc student of Department of Anesthesiology of Federal University of Rio de Janeiro, Brazil.

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 21, 2016
• Study Start: October 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 7, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)