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TerminatedNCT00445055DIPAVOUpdated Dec 13, 2011

Evaluation of 2 Doses of Intravenous Droperidol in the Prevention of Postoperative Nausea

A Phase 4 interventional study of Droperidol in Nausea and Vomiting, sponsored by University Hospital, Bordeaux. Terminated at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-12-13.

Sponsored by University Hospital, Bordeaux · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
71
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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.

Read the 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
02

Conditions studied

  • Nausea
  • Vomiting

Keywords

  • Thyroidectomy
  • Nausea
  • Vomiting
  • Droperidol
03

In context

Nausea

822 studies on the registry are indexed under Nausea; 104 are open to participants now.

This study's enrollment of 71 is below the median of 115 across 703 interventional studies indexed under Nausea.

Browse Nausea studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
71 participants (actual)

Study arms

  • Experimental
    1

    Intravenous injection of 0,625 mg Droperidol, 30 min before the end of anesthesia

    Drug: Droperidol

  • Experimental
    2

    Intravenous injection of 2,5 mg Droperidol, 30 min before the end of anesthesia

    Drug: Droperidol

  • Placebo comparator
    3

    Intravenous injection of NaCl 9% (Placebo), 30 min before the end of anesthesia

    Drug: Droperidol

Interventions

  • DrugDroperidol

    Intravenous injection

06

What researchers measure

Primary outcomes

  1. No vomiting episode

    Time frame: During the first four hours after intervention

Secondary outcomes

  1. Light nausea

    Time frame: 24h post operative

  2. Control of nausea

    Time frame: 24h post operative

  3. Anti-vomiting treatment

    Time frame: 24h post operative

  4. Adverse events

    Time frame: 24h post operative

  5. Modification of electrocardiograph

    Time frame: 30 min and 120 min after injection

  6. - Score of sedation

    Time frame: 24h post operative

07

Study locations

1 site
  • Département d'Anesthésie-Réanimation II ; Groupe Hospitalier Sud, CHU de Bordeaux
    PESSAC Cedex, 33604, France
08

References and documents

Publications

  • Kovac AL. Prevention and treatment of postoperative nausea and vomiting. Drugs. 2000 Feb;59(2):213-43. doi: 10.2165/00003495-200059020-00005. PubMed 10730546 ↗
  • Williams OA, Clarke FL, Harris RW, Smith P, Peacock JE. Addition of droperidol to patient-controlled analgesia: effect on nausea and vomiting. Anaesthesia. 1993 Oct;48(10):881-4. doi: 10.1111/j.1365-2044.1993.tb07419.x. PubMed 8031342 ↗
  • Gan TJ, Meyer T, Apfel CC, Chung F, Davis PJ, Eubanks S, Kovac A, Philip BK, Sessler DI, Temo J, Tramer MR, Watcha M; Department of Anesthesiology, Duke University Medical Center. Consensus guidelines for managing postoperative nausea and vomiting. Anesth Analg. 2003 Jul;97(1):62-71, table of contents. doi: 10.1213/01.ane.0000068580.00245.95. PubMed 12818945 ↗
  • Wang JJ, Ho ST, Lee SC, Liu YC, Liu YH, Liao YC. The prophylactic effect of dexamethasone on postoperative nausea and vomiting in women undergoing thyroidectomy: a comparison of droperidol with saline. Anesth Analg. 1999 Jul;89(1):200-3. doi: 10.1097/00000539-199907000-00036. PubMed 10389804 ↗
  • Henzi I, Sonderegger J, Tramer MR. Efficacy, dose-response, and adverse effects of droperidol for prevention of postoperative nausea and vomiting. Can J Anaesth. 2000 Jun;47(6):537-51. doi: 10.1007/BF03018945. PubMed 10875717 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00445055
Lead sponsor
University Hospital, Bordeaux
Collaborators
Kyowa Kirin Co., Ltd.
Responsible party
Sponsor
First posted
Mar 8, 2007
Start date
Apr 2007
Primary completion
Apr 2009
Completion
Apr 2009
Last update
Dec 13, 2011

Study contacts

Gérard JANVIER, MD
study director · University Hospital, Bordeaux
Laure BAUDOUIN, Dr
principal investigator · University Hospital, Bordeaux

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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