Role of Droperidol in Postoperative Vomiting

Phase 4

Completed

• Conditions: Vomiting
• Interventions: Drug: Saline solution; Drug: Droperidol

• Registration Number: NCT00702442
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief 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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-19
• Study First Submitted QC: 2008-06-19
• Study First Posted: 2008-06-20
• Status Verified: 2009-09
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Last Update Submitted: 2011-07-25
• Last Update Posted: 2011-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patient more than 18 years old
• Patients scheduled for laparoscopic cholecystectomy
• Informed consent obtained from the patient

Exclusion Criteria

• Age < 18 years old
• Contraindication to laparoscopic surgery
• Present a severe depressive syndrome
• Pregnancy women
• Trouble of cardiac rate
• Alcoholism
• Contra-indication for Droperidol prescription

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Saline solution	Placebo Administrated 30min prior to operation
B	Droperidol	0.625 mg Droperidol administrated i.v 30 min prior surgery

Primary Outcome Measures

Name	Time	Method
Vomiting episodes	24 hours

Secondary Outcome Measures

Name	Time	Method
Light nausea	24 hours
Control of nausea	24 hours
Anti-vomiting treatment	24 hours
Adverse events	24 hours
Modification of electrocardiograph	24 hours

Trial Locations

Locations (1)

3rd Department of Surgery, AHEPA University Hospital; 🇬🇷 Thessaloniki, Greece