Aprepitant for Post-operative Nausea

Northwell Health

Status: Completed

Conditions: Postoperative Nausea

Treatments: Procedure: Aprepitant; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01020903

09-045

Details and patient eligibility

About

Anesthesia, especially for laparoscopic surgery, can cause post-operative nausea and vomiting. Most patients are given two drugs, decadron and ondansetron, to try to minimize this. This study is to determine if a new drug, aprepitant, would add any benefit in terms of post-op nausea prevention. All laparoscopic cholecystectomy study patients will receive decadron and ondansetron. Half the patients will receive aprepitant in addition. The other half will receive placebo. The study will be randomized and double-blind.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Laparoscopic cholecystectomy patients.
• Must be able to swallow a pill.

Exclusion criteria

• Liver failure,
• Age less than 18.
• Pregnancy, breast-feeding.
• Pre-op vomiting.
• Allergy to aprepitant.
• Need for post-op gastric drainage.
• Use of drugs that interact with aprepitant.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

200 participants in 2 patient groups, including a placebo group

Aprepitant

Active Comparator group

Treatment:

Procedure: Aprepitant

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo