NCT00445055

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2007

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

December 13, 2011

Status Verified

December 1, 2011

Enrollment Period

2 years

First QC Date

March 6, 2007

Last Update Submit

December 12, 2011

Conditions

NauseaVomiting

Keywords

ThyroidectomyNauseaVomitingDroperidol

Outcome Measures

Primary Outcomes (1)

  • No vomiting episode

    During the first four hours after intervention

Secondary Outcomes (6)

  • Light nausea

    24h post operative

  • Control of nausea

    24h post operative

  • Anti-vomiting treatment

    24h post operative

  • Adverse events

    24h post operative

  • Modification of electrocardiograph

    30 min and 120 min after injection

  • +1 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL

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

Drug: Droperidol

2

EXPERIMENTAL

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

Drug: Droperidol

3

PLACEBO COMPARATOR

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

Drug: Droperidol

Interventions

DroperidolDRUG

Intravenous injection

123

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age \< 18 years old
  • Male
  • Obesity
  • Has a severe depressive syndrome
  • Pregnancy women
  • Trouble with cardiac rate
  • Alcoholism
  • Contra-indication for Droperidol prescription

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Département d'Anesthésie-Réanimation II ; Groupe Hospitalier Sud, CHU de Bordeaux

Pessac, 33604, France

Location

Related Publications (5)

  • Kovac AL. Prevention and treatment of postoperative nausea and vomiting. Drugs. 2000 Feb;59(2):213-43. doi: 10.2165/00003495-200059020-00005.

    PMID: 10730546BACKGROUND

  • 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.

    PMID: 8031342BACKGROUND

  • 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.

    PMID: 12818945BACKGROUND

  • 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.

    PMID: 10389804BACKGROUND

  • 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.

    PMID: 10875717BACKGROUND

MeSH Terms

Conditions

NauseaVomiting

Interventions

Droperidol

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ButyrophenonesKetonesOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Gérard JANVIER, MD

    University Hospital, Bordeaux

    STUDY DIRECTOR

  • Laure BAUDOUIN, Dr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2007

First Posted

March 8, 2007

Study Start

April 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

December 13, 2011

Record last verified: 2011-12

Locations

FR(1)