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Sponsors and Collaborators: |
Aristotle University Of Thessaloniki AHEPA University Hospital |
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Information provided by: | Aristotle University Of Thessaloniki |
ClinicalTrials.gov Identifier: | NCT00702442 |
Protocol Synopsis
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
Condition | Intervention | Phase |
---|---|---|
Vomiting |
Drug: Droperidol Drug: Saline solution |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Role of Droperidol in Postoperative Vomiting: Phase IV Study |
Estimated Enrollment: | 100 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Placebo Comparator
Placebo Administrated 30min prior to operation
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Drug: Saline solution
Saline solution administrated i.v 30 min prior surgery
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B: Experimental
0.625 mg Droperidol administrated i.v 30 min prior surgery
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Drug: Droperidol
0.625 mg droperidol administrated i.v prior to laparoscopic cholecystectomy
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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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Isaak I Kesisoglou, M.D, PhD | +2310994602 | ikesis@hotmail.com |
Greece, Macedonia | |
3rd Department of Surgery, AHEPA University Hospital | Recruiting |
Thessaloniki, Macedonia, Greece, 55236 | |
Contact: Isaak I Kesisoglou, M.D, PhD +2310994602 ikesis@hotmail.com | |
Principal Investigator: Isaak I Kesisoglou, M.D, PhD | |
Principal Investigator: Vasilios Grosomanidis, M.D, PhD | |
Sub-Investigator: Ellada Kiourtsieva, M.D | |
Sub-Investigator: Theodossis S Papavramidis, M.D |
Responsible Party: | 3rd Department of Surgery, AHEPA University Hospital ( Assistant Professor Isaak Kesisoglou ) |
Study ID Numbers: | 597/4-6-2008 |
Study First Received: | June 19, 2008 |
Last Updated: | August 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00702442 |
Health Authority: | Greece: Ethics Committee |
Nausea, Vomiting Vomiting episodes |
Signs and Symptoms Postoperative Nausea and Vomiting Dopamine Vomiting |
Postoperative Complications Signs and Symptoms, Digestive Droperidol Nausea |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Gastrointestinal Agents Antiemetics Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Adjuvants, Anesthesia Pathologic Processes Autonomic Agents Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |