Role of Droperidol in Postoperative Vomiting

This study has been completed.
Sponsor:
Collaborator:
AHEPA University Hospital
Information provided by:
Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00702442
First received: June 19, 2008
Last updated: July 25, 2011
Last verified: September 2009
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Role of Droperidol in Postoperative Vomiting: Phase IV Study

Resource links provided by NLM:


Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • Vomiting episodes [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

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

Enrollment: 100
Study Start Date: June 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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

No publications provided

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
Study First Received: June 19, 2008
Last Updated: July 25, 2011
Health Authority: Greece: Ethics Committee

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
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014