A Pilot Study to Evaluate Barhemsys for the Prevention of Postoperative Nausea And Vomiting in the Bariatric Surgery Population

Incidence of complete response to established Post-operative Nausea and Vomiting

Effectiveness of Barhemsys in the treatment of established nausea or vomiting in the high-risk bariatric surgical population during Post Anesthesia Care Unit stay. Failure of complete response is defined as subject emesis or use of rescue medication during Post Anesthesia Care Unit stay following a treatment dose of Barhemsys.

Time frame: Until Patient leave Post Anesthesia Care Unit (60-90 minutes)

Number of participants with no nausea

Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. "No nausea" means no score ≥ 1.

Time frame: Up to 24 hours following surgery

Number of Participants with no Emesis

Emesis is defined as vomiting (production of even the smallest amount of stomach contents) or retching (muscular movements of vomiting but without expulsion of stomach contents, usually because of an empty stomach)

Time frame: Up to 24 hours following surgery

Number of Participants With no Use of Rescue Medication

Any agent given in the post-operative period with the intention of providing anti-emetic rescue is counted as rescue antiemetic medication for the purposes of efficacy determination, even if it did not achieve control of emesis or was given incorrectly (e.g., wrong dosage or route). Any agent given in the postoperative period which would be expected, by virtue of its pharmacology, dosage, and route, to exert a clinically meaningful antiemetic effect was considered as rescue antiemetic medication, even if administered inadvertently or without the intention of providing rescue.