Role of Droperidol in Postoperative Vomiting

Vomiting Clinical Trial

Official title:

Role of Droperidol in Postoperative Vomiting: Phase IV Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00702442
• Other study ID #: 597/4-6-2008
• Status: Completed
• Phase: Phase 4
• First received: June 19, 2008
• Last updated: July 25, 2011
• Start date: June 2008
• Est. completion date: July 2011

Study information

• Verified date: September 2009
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vomiting

Intervention

Drug:
• Droperidol
0.625 mg droperidol administrated i.v prior to laparoscopic cholecystectomy
• Saline solution
Saline solution administrated i.v 30 min prior surgery

Locations

Country	Name	City	State
Greece	3rd Department of Surgery, AHEPA University Hospital	Thessaloniki	Macedonia
Greece	3rd Department of Surgery, AHEPA University Hospital	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki	AHEPA University Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vomiting episodes		24 hours	Yes
Secondary	Light nausea		24 hours	Yes
Secondary	Control of nausea		24 hours	Yes
Secondary	Anti-vomiting treatment		24 hours	Yes
Secondary	Adverse events		24 hours	Yes
Secondary	Modification of electrocardiograph		24 hours	Yes