NCT03023306

Preemptive Versus Preventive Antiemetic Treatment

Effectiveness of Preemptive Versus Preventive Antiemetic Treatment in Patients Undergoing Laparoscopic Cholecystectomy. A Randomized Double Blind Trial.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (estimated)
• Sponsor: University of Athens · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Patients aged between 20 and 70 years, ASA physical status I-III, and scheduled for laparoscopic cholecystectomy under general anaesthesia will be enrolled in the study. Patients will be randomized to the preemptive group to receive an antiemetic regime 1h before the start of surgery or to the intraoperative group to receive the same antiemetic drugs in the same doses intraoperatively, 30 min before the end of surgery. In the operating room standard monitoring and a standardized anesthetic technique will be implemented in all patients. Nausea, vomiting, retching and PONV (cumulative) will be recorded at PACU, at 4h, 8h and 24h postoperatively. Pain scores assessed by NRS (numerical rating scale) will be recorded at the same time points. Also, when patients received fluids and solid food by mouth will be recorded.

Conditions

• Postoperative Nausea and Vomiting

Interventions

Type	Name	Description
OTHER	Antiemetics perioperatively	Preemptive group ondansetron 4 mg will be administered 1h before surgery Intraoperative group Ondansetron 4 mg will be administered intraoperatively

Timeline

• Start date: 2018-11-01
• Primary completion: 2020-11-01
• Completion: 2020-11-01
• First posted: 2017-01-18
• Last updated: 2018-11-02

Locations

1 site across 1 country: Greece