Neurokinin Receptor Antagonist Associated to Ondansetron in PONV

Instituto do Cancer do Estado de São Paulo

Status and phase: Completed; Phase 4

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: Aprepitant

Study type: Interventional

Funder types: Other

Identifiers

NCT02357693

CEP 280/12

Details and patient eligibility

About

The purpose of this study is to determine whether patients at high risk for postoperative nausea and vomiting can benefit from aprepitant, ondansetron and dexamethasone in the perioperative period.

Full description

High risk surgical patients for PONV, scheduled for laparoscopic surgery will be distributed in two groups: Group I will receive aprepitant 80 mg per os and Group II will receive placebo per os, one hour before surgery. In the operating room, patients will be submitted to combined intravenous general anesthesia plus spinal anesthesia. All patients will receive dexamethasone 4 mg and ondansetron 4 mg intravenously during the surgical procedure. After surgery, patients will be monitored for pain, nausea and vomiting during 24 hours.

Enrollment: 90 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• high risk patients for nausea and vomiting

Exclusion criteria

• cardiovascular disease, or hypersensibility to any of the drugs involved in the study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups, including a placebo group

aprepitant

Experimental group

Description:

aprepitant 80 mg one hour before surgery

Treatment:

Drug: Aprepitant

placebo

Placebo Comparator group

Description:

oral placebo one hour before surgery

Treatment:

Drug: Aprepitant