At a glance
ClinicalIndex Comparison Record- ✓Age 18 to 85 years
- ✓ASA physical status I to III
- ✓Scheduled for neurological surgery requiring opening of the cranium and dura under general anesthesia
- ✓Surgery expected to require at least 1 hour of general anesthesia
- ✕Age <18 or >85 years
- ✕ASA classification V
- ✕Known hypersensitivity to 5-HT3 antagonists or any agent in the anesthesia regimen
- ✕Retching, vomiting, or moderate to severe nausea in the 24 hours prior to anesthesia, or chronic nausea/vomiting
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Studying the Effectiveness of Triple Therapy With Palonosetron, Dexamethasone and Promethazine for Prevention of Post Operative Nausea and Vomiting in High Risk Patients Undergoing Neurological Surgery and General Anesthesia
In Brief
A Phase 4 clinical trial evaluating Palonosetron 0.075 mg IV, Dexamethasone 10 mg IV, and 1 other intervention for Postoperative Nausea and Vomiting. Completed, enrolled 40 participants.
Detailed 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.
Study Details
Timeline
Interventions
At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.
At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.
At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis.