NCT00702442

Role of Droperidol in Postoperative Vomiting

Role of Droperidol in Postoperative Vomiting: Phase IV Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Aristotle University Of Thessaloniki · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Protocol title: Role of low dose droperidol in postoperative vomiting Purpose: Evaluate the efficacy of droperidol to postoperative nausea and vomiting when administrated at the introduction to anesthesia, prior to surgery Design: Prospective, randomized, placebo-controlled study Patient Population: Male or female subjects 18 years of age or older who are scheduled for laparoscopic cholecystectomy No. of Subjects: 100 patients divided into two groups, estimated up to 6 months to enroll Duration of Treatment: Prior operation Duration of Follow-up: Follow-up will be performed for 24 hours postoperatively Endpoints: To evaluate the effectiveness of low dose droperidol when administered Prior surgery

Detailed description

In this prospective, randomized, placebo-controlled study, the researchers determined whether 0.625 mg (1/2 amp) IV droperidol given at the initiation of general anesthesia reduces the incidence of immediate and delayed post operative nausea and vomiting (PONV) in laparoscopic cholecystectomy population. One hundred patients receiving general anesthesia for laparoscopic cholecystectomy received droperidol 0.625 mg (1/2 amp) mg or placebo prior operation.

Conditions

• Vomiting

Interventions

Type	Name	Description
DRUG	Droperidol	0.625 mg droperidol administrated i.v prior to laparoscopic cholecystectomy
DRUG	Saline solution	Saline solution administrated i.v 30 min prior surgery

Timeline

• Start date: 2008-06-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2008-06-20
• Last updated: 2011-07-26

Locations

2 sites across 1 country: Greece