Role of Droperidol in Postoperative Vomiting

Study Overview
=================
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.

Official Title
-----------------
Role of Droperidol in Postoperative Vomiting: Phase IV Study

Conditions
-----------------
Vomiting

Intervention / Treatment
-----------------
* Drug: Droperidol
* Drug: Saline solution


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br>Placebo Administrated 30min prior to operation | Drug: Saline solution<br>* Saline solution administrated i.v 30 min prior surgery<br>|
| Experimental: B<br>0.625 mg Droperidol administrated i.v 30 min prior surgery | Drug: Droperidol<br>* 0.625 mg droperidol administrated i.v prior to laparoscopic cholecystectomy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vomiting episodes |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Light nausea |  | 24 hours | 
| Control of nausea |  | 24 hours | 
| Anti-vomiting treatment |  | 24 hours | 
| Adverse events |  | 24 hours | 
| Modification of electrocardiograph |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nausea, Vomiting, Vomiting episodes