Role of Droperidol in Postoperative Vomiting - Full Text View

Sponsors and Collaborators:	Aristotle University Of Thessaloniki AHEPA University Hospital
Information provided by:	Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:	NCT00702442

Purpose

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

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Sodium chloride Droperidol

U.S. FDA Resources

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

Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:

Vomiting episodes [ Time Frame: 24hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Light nausea Control of nausea Anti-vomiting treatment Adverse events Modification of electrocardiograph [ Time Frame: 24hours ] [ Designated as safety issue: Yes ]

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
A: Placebo Comparator Placebo Administrated 30min prior to operation	Drug: Saline solution Saline solution administrated i.v 30 min prior surgery
B: Experimental 0.625 mg Droperidol administrated i.v 30 min prior surgery	Drug: Droperidol 0.625 mg droperidol administrated i.v prior to laparoscopic cholecystectomy

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702442

Contacts

Contact: Isaak I Kesisoglou, M.D, PhD

+2310994602

ikesis@hotmail.com

Locations

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

Sponsors and Collaborators

Aristotle University Of Thessaloniki

AHEPA University Hospital

More Information

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

Keywords provided by Aristotle University Of Thessaloniki:

Nausea, Vomiting
Vomiting episodes

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Nausea and Vomiting
Dopamine
Vomiting

Postoperative Complications
Signs and Symptoms, Digestive
Droperidol
Nausea

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 15, 2009