Palonosetron Associated to Aprepitant in Prophylaxis of PONV

Postoperative Nausea and Vomiting Clinical Trial

— PONV  

Official title:

Evaluation of Palonosetron and Palonosetron/Aprepitant in Post Operative Nausea and Vomiting Incidence in Oncological Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02431286
• Other study ID #: NP297/12
• Secondary ID: 2012/11298-8
• Status: Recruiting
• Phase: Phase 4
• First received: January 31, 2015
• Last updated: April 30, 2015
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2015
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: Angela Sousa, phD
• Phone: 551126616680
• Email: angela.sousa[@]icesp.org.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to investigate if aprepitant in association with palonosetron and dexamethasone could reduce the incidence of PONV in high-risk patients for this symptom, undergoing cancer surgery mastectomies.

Description:

Postoperative nausea and vomiting (PONV) is a common anesthetic complication that occurs in approximately 30% of the surgical population and can reach up to 70% in high risk patients for PONV. Advances have been made to prevent PONV, but the incidence is still high in certain groups of patients. In high risk patients, pharmacologic intervention should consist of multimodal therapy, targeting different mechanisms of action. The objective of this study is to investigate if aprepitant in association with palonosetron and dexamethasone could reduce the incidence of PONV in high-risk patients for this symptom, undergoing cancer surgery mastectomies. METHODS: this is a randomized and double blind clinical trial. Female high-risk patients for PONV(Apfel score 3 or 4) scheduled for mastectomy that agree with the study and signed the informed consent, are randomly distributed into one of two groups: Group A, aprepitant 80 mg per os one hour before the surgery and Group B will receive placebo by the same route one hour before surgery, in a blinded way. After induction of anesthesia, dexamethasone 4 mg and palonosetron 0,075mg are intravenously administered to all patients. After the end of the surgery, a patient-controlled analgesia (PCA) device will be intravenously inserted in all patients. In the postoperative period, patients will be evaluated for nausea, vomiting and pain intensity in the recovery room and after 24 hours

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• patients submitted to breast cancer surgery

• non smokers

Exclusion Criteria:

• any contraindication to one of the drugs

• mental disease

• inability to understand the method or refusal to participate in the research

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Aprepitant
aprepitant will be administered in preoperative period; intravenous palonosetron and dexamethasone will be administered intraoperatively
• Placebo
Placebo will be administered in the preoperative period; intravenous palonosetron and dexamethasone will be administered intraoperatively
• Dexamethasone
Dexamethasone and plonosetron will be administered intraoperatively in both groups, durong surgery

Locations

Country	Name	City	State
Brazil	Angela Maria Sousa	Sao Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

George E, Hornuss C, Apfel CC. Neurokinin-1 and novel serotonin antagonists for postoperative and postdischarge nausea and vomiting. Curr Opin Anaesthesiol. 2010 Dec;23(6):714-21. doi: 10.1097/ACO.0b013e32833f9f7b. Review. — View Citation

Moon HY, Baek CW, Choi GJ, Shin HY, Kang H, Jung YH, Woo YC, Kim JY, Park SG. Palonosetron and aprepitant for the prevention of postoperative nausea and vomiting in patients indicated for laparoscopic gynaecologic surgery: a double-blind randomised trial. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of postoperative nausea and vomiting	intensity of nausea	24 hours	No
Secondary	postoperative pain measured by Verbal and descriptive scale	pain intensity in the first 24 hours after surgery	24 hours	No