Conditions: Postoperative Nausea and Vomiting
Keywords: Palonosetron Craniotomy Nausea Vomiting
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 40
Healthy volunteers: no

Brief summary:
Postoperative nausea and vomiting (PONV) is a displeasing experience that distresses surgical patients during the first 24 hours after a surgical procedure. The incidence of postoperative nausea occurs in about 50%, the incidence of postoperative vomiting is about 30%, and in high-risk patients, the PONV rate could be as high as 80%. Therefore, the study design of this single arm, non-randomized, pilot study assessed the efficacy and safety profile of a triple therapy combination with palonosetron, dexamethasone and promethazine to prevent PONV in patients undergoing craniotomies under general anesthesia.

Detailed description:
At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis. After surgery, subjects were transferred to the surgical intensive care unit (SICU) or post anesthesia care unit as clinically indicated. Ondansetron 4 mg IV was administered as primary rescue medication to subjects with PONV symptoms. PONV was assessed and collected every 24 hours for 5 days via direct interview and/or medical charts review.

Arms:
arm 1: At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis.

Interventions: intervention 1: Palonosetron 0.075 mg IV intervention 2: Dexamethasone 10 mg IV intervention 3: Promethazine 25 mg IV
Intervention descriptions: intervention 1: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis. intervention 2: At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis. intervention 3: At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis.

Protocol document: