Role of Droperidol in Postoperative Vomiting: Phase IV Study

Role of Droperidol in Postoperative Vomiting

Sponsors

Lead sponsor: Aristotle University Of Thessaloniki

Collaborator: AHEPA University Hospital

Source 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.

Overall Status Completed
Start Date June 2008
Completion Date July 2011
Primary Completion Date July 2011
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Vomiting episodes 24 hours
Secondary Outcome
Measure 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
Enrollment 100
Condition
Intervention

Intervention type: Drug

Intervention name: Droperidol

Description: 0.625 mg droperidol administrated i.v prior to laparoscopic cholecystectomy

Arm group label: B

Intervention type: Drug

Intervention name: Saline solution

Description: Saline solution administrated i.v 30 min prior surgery

Arm group label: A

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Isaak Kesisoglou Principal Investigator Associate Professor in Surgery
Location
facility
3rd Department of Surgery, AHEPA University Hospital
3rd Department of Surgery, AHEPA University Hospital
Location Countries

Greece

Verification Date

September 2009

Responsible Party

Name title: Assistant Professor Isaak Kesisoglou

Organization: 3rd Department of Surgery, AHEPA University Hospital

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: A

Arm group type: Placebo Comparator

Description: Placebo Administrated 30min prior to operation

Arm group label: B

Arm group type: Experimental

Description: 0.625 mg Droperidol administrated i.v 30 min prior surgery

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov