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Role of Droperidol in Postoperative Vomiting

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ClinicalTrials.gov Identifier: NCT00702442
Recruitment Status : Completed
First Posted : June 20, 2008
Last Update Posted : July 26, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
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


Condition or disease Intervention/treatment Phase
Vomiting Drug: Droperidol Drug: Saline solution Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Role of Droperidol in Postoperative Vomiting: Phase IV Study
Study Start Date : June 2008
Primary Completion Date : July 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Droperidol
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Vomiting episodes [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Light nausea [ Time Frame: 24 hours ]
  2. Control of nausea [ Time Frame: 24 hours ]
  3. Anti-vomiting treatment [ Time Frame: 24 hours ]
  4. Adverse events [ Time Frame: 24 hours ]
  5. Modification of electrocardiograph [ Time Frame: 24 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00702442


Locations
Greece
3rd Department of Surgery, AHEPA University Hospital
Thessaloniki, Macedonia, Greece, 55236
3rd Department of Surgery, AHEPA University Hospital
Thessaloniki, Greece, 55236
Sponsors and Collaborators
Aristotle University Of Thessaloniki
AHEPA University Hospital
Investigators
Principal Investigator: Isaak Kesisoglou Associate Professor in Surgery
More Information

Responsible Party: Assistant Professor Isaak Kesisoglou, 3rd Department of Surgery, AHEPA University Hospital
ClinicalTrials.gov Identifier: NCT00702442     History of Changes
Other Study ID Numbers: 597/4-6-2008
First Posted: June 20, 2008    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: September 2009

Keywords provided by Aristotle University Of Thessaloniki:
Nausea, Vomiting
Vomiting episodes

Additional relevant MeSH terms:
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Nausea
Droperidol
Adjuvants, Anesthesia
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action