Palonosetron Associated to Aprepitant in Prophylaxis of PONV

NCT ID: NCT02431286

Last Updated: 2015-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-12-31

Brief 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.

Detailed 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

Conditions

Postoperative Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Aprepitant

patient will receive aprepitant 80 mg per os one hour before surgery; palonosetron and dexamethasone will be intravenously administered during surgery

Group Type: EXPERIMENTAL

Aprepitant

Intervention Type: DRUG

aprepitant will be administered in preoperative period; intravenous palonosetron and dexamethasone will be administered intraoperatively

Dexamethasone

Intervention Type: DRUG

Dexamethasone and plonosetron will be administered intraoperatively in both groups, durong surgery

placebo

patient will receive placebo per os one hour before surgery; palonosetron and dexamethasone will be intravenously administered during surgery

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered in the preoperative period; intravenous palonosetron and dexamethasone will be administered intraoperatively

Dexamethasone

Intervention Type: DRUG

Dexamethasone and plonosetron will be administered intraoperatively in both groups, durong surgery

Interventions

Aprepitant

aprepitant will be administered in preoperative period; intravenous palonosetron and dexamethasone will be administered intraoperatively

Intervention Type: DRUG

Placebo

Placebo will be administered in the preoperative period; intravenous palonosetron and dexamethasone will be administered intraoperatively

Intervention Type: DRUG

Dexamethasone

Dexamethasone and plonosetron will be administered intraoperatively in both groups, durong surgery

Intervention Type: DRUG

Other Intervention Names

Emend; Saline; Decadron

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hazem a Ashmawi, phD

Role: STUDY_DIRECTOR

University of Sao Paulo

Locations

Angela Maria Sousa

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Angela Sousa, phD

Role: CONTACT

angela.sousa@icesp.org.br

551126616680

Facility Contacts

angela sousa, phD

Role: primary

angela.sousa@icesp.org.br

3893-2000 ext. 6680

References

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. BMC Anesthesiol. 2014 Aug 10;14:68. doi: 10.1186/1471-2253-14-68. eCollection 2014.

Reference Type: RESULT

PMID: 25165427 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20871394 (View on PubMed)

Grigio TR, Sousa AM, Magalhaes GGN, Ashmawi HA, Vieira JE. Aprepitant plus palonosetron for the prevention of postoperative nausea and vomiting after breast cancer surgery: a double blind, randomized trial. Clinics (Sao Paulo). 2020;75:e1688. doi: 10.6061/clinics/2020/e1688. Epub 2020 Sep 2.

Reference Type: DERIVED

PMID: 32901672 (View on PubMed)

Other Identifiers

2012/11298-8

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NP297/12

Identifier Type: -

Identifier Source: org_study_id