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Evaluation of 2 Doses of Intravenous Droperidol in the Prevention of Postoperative Nausea (DIPAVO)

This study has been terminated.
Sponsor:
Collaborator:
Prostrakan Pharmaceuticals
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00445055
First received: March 6, 2007
Last updated: December 12, 2011
Last verified: December 2011
  Purpose

In this prospective, randomised, placebo-controlled study, the researchers determined whether 0.625 mg or 2.5 mg of IV droperidol given 30 min before emergence from general anaesthesia reduces the incidence of immediate and delayed post operative nausea and vomiting (PONV) in thyroid surgical female population. Two hundred and forty six female patients receiving general anaesthesia for thyroid surgery received either droperidol 0.625 mg or droperidol 2.5 mg or placebo before emergence.


Condition Intervention Phase
Nausea
Vomiting
Drug: Droperidol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Study of Evaluation of the Profile of Efficiency / Tolerance of 2 Doses of Intravenous Droperidol in the Prevention of the Postoperative Nausea and Vomits Related to the Surgery of the Thyroid

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • No vomiting episode [ Time Frame: During the first four hours after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Light nausea [ Time Frame: 24h post operative ] [ Designated as safety issue: No ]
  • Control of nausea [ Time Frame: 24h post operative ] [ Designated as safety issue: No ]
  • Anti-vomiting treatment [ Time Frame: 24h post operative ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 24h post operative ] [ Designated as safety issue: Yes ]
  • Modification of electrocardiograph [ Time Frame: 30 min and 120 min after injection ] [ Designated as safety issue: Yes ]
  • - Score of sedation [ Time Frame: 24h post operative ] [ Designated as safety issue: Yes ]

Enrollment: 71
Study Start Date: April 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Intravenous injection of 0,625 mg Droperidol, 30 min before the end of anesthesia
Drug: Droperidol
Intravenous injection
Experimental: 2
Intravenous injection of 2,5 mg Droperidol, 30 min before the end of anesthesia
Drug: Droperidol
Intravenous injection
Placebo Comparator: 3
Intravenous injection of NaCl 9% (Placebo), 30 min before the end of anesthesia
Drug: Droperidol
Intravenous injection

Detailed Description:
  • Principal Objective : Our study examined one main question: Are there difference in efficacy between droperidol IV 0.625 mg or 2.5 mg for the treatment or prophylaxis of PONV to surgical patient undergoing thyroid surgery when they receive it 30 min before emergence from general anaesthesia?
  • Secondary Objective :

    • comparison of the % of patients in every group:

      • having a complete control of their nausea
      • requiring secondarily the appeal to another anti-emetic treatment in postoperative
      • presenting an Adverse event
    • Compare score of sedation in ach groups
    • Evaluate electrocardiograph
    • Compare the morphine consumption
  • Study design : Prospective, randomized, monocenter, double-blind study
  • Inclusion criteria :

    • Female
    • More than 18 years old
    • Patients scheduled for thyroid surgery
    • Simplified Apfel score ≥ 2
    • ASA score : 1-2
    • Informed consent obtained from the patient
    • the women in age of procreate must have a reliable contraceptive method
  • Exclusion criteria :

    • age < 18 years old
    • male
    • obesity
    • present a severe depressive syndrome
    • pregnancy women
    • trouble of cardiac rate
    • alcoholism
    • contra-indication for Droperidol prescription
  • Study plan: three parallel groups will receive 2 different doses of Droperidol or placebo at the end of surgery.

    • Group 1: 0,625mg of Droperidol at the end of surgery
    • Group 2: 2,5mg of Droperidol at the end of surgery
    • Group 3: Placebo at the end of surgery
  • Number of subjects : 246
  Eligibility

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

Inclusion Criteria:

  • Female
  • More than 18 years old
  • Patients scheduled for thyroid surgery
  • Simplified Apfel score ≥ 2
  • ASA score : 1-2
  • Informed consent obtained from the patient
  • Women able to procreate must have a reliable contraceptive method

Exclusion Criteria:

  • Age < 18 years old
  • Male
  • Obesity
  • Has a severe depressive syndrome
  • Pregnancy women
  • Trouble with cardiac rate
  • Alcoholism
  • Contra-indication for Droperidol prescription
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445055

Locations
France
Département d'Anesthésie-Réanimation II ; Groupe Hospitalier Sud, CHU de Bordeaux
PESSAC Cedex, France, 33604
Sponsors and Collaborators
University Hospital, Bordeaux
Prostrakan Pharmaceuticals
Investigators
Study Director: Gérard JANVIER, MD University Hospital, Bordeaux
Principal Investigator: Laure BAUDOUIN, Dr University Hospital, Bordeaux
  More Information

Publications:
Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00445055     History of Changes
Other Study ID Numbers: CHUBX 2006/02
Study First Received: March 6, 2007
Last Updated: December 12, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Thyroidectomy
Nausea
Vomiting
Droperidol

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms
Signs and Symptoms, Digestive
Droperidol
Adjuvants, Anesthesia
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 24, 2014