Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2008-06-30
2011-07-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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A
Placebo Administrated 30min prior to operation
Saline solution
Saline solution administrated i.v 30 min prior surgery
B
0.625 mg Droperidol administrated i.v 30 min prior surgery
Droperidol
0.625 mg droperidol administrated i.v prior to laparoscopic cholecystectomy
Interventions
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Droperidol
0.625 mg droperidol administrated i.v prior to laparoscopic cholecystectomy
Saline solution
Saline solution administrated i.v 30 min prior surgery
Eligibility Criteria
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Inclusion Criteria
* Patients scheduled for laparoscopic cholecystectomy
* Informed consent obtained from the patient
Exclusion Criteria
* Contraindication to laparoscopic surgery
* Present a severe depressive syndrome
* Pregnancy women
* Trouble of cardiac rate
* Alcoholism
* Contra-indication for Droperidol prescription
18 Years
ALL
No
Sponsors
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AHEPA University Hospital
OTHER
Aristotle University Of Thessaloniki
OTHER
Responsible Party
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3rd Department of Surgery, AHEPA University Hospital
Principal Investigators
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Isaak Kesisoglou
Role: PRINCIPAL_INVESTIGATOR
Associate Professor in Surgery
Locations
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3rd Department of Surgery, AHEPA University Hospital
Thessaloniki, Macedonia, Greece
3rd Department of Surgery, AHEPA University Hospital
Thessaloniki, , Greece
Countries
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Other Identifiers
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597/4-6-2008
Identifier Type: -
Identifier Source: org_study_id
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