Evaluation of 2 Doses of Intravenous Droperidol in the Prevention of Postoperative Nausea
NCT ID: NCT00445055
Last Updated: 2011-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
71 participants
INTERVENTIONAL
2007-04-30
2009-04-30
Brief Summary
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Detailed Description
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* 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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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1
Intravenous injection of 0,625 mg Droperidol, 30 min before the end of anesthesia
Droperidol
Intravenous injection
2
Intravenous injection of 2,5 mg Droperidol, 30 min before the end of anesthesia
Droperidol
Intravenous injection
3
Intravenous injection of NaCl 9% (Placebo), 30 min before the end of anesthesia
Droperidol
Intravenous injection
Interventions
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Droperidol
Intravenous injection
Eligibility Criteria
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Inclusion Criteria
* 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
* Male
* Obesity
* Has a severe depressive syndrome
* Pregnancy women
* Trouble with cardiac rate
* Alcoholism
* Contra-indication for Droperidol prescription
18 Years
FEMALE
No
Sponsors
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Kyowa Kirin Co., Ltd.
INDUSTRY
University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Gérard JANVIER, MD
Role: STUDY_DIRECTOR
University Hospital, Bordeaux
Laure BAUDOUIN, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Locations
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Département d'Anesthésie-Réanimation II ; Groupe Hospitalier Sud, CHU de Bordeaux
Pessac, , France
Countries
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References
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Kovac AL. Prevention and treatment of postoperative nausea and vomiting. Drugs. 2000 Feb;59(2):213-43. doi: 10.2165/00003495-200059020-00005.
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.
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.
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.
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.
Other Identifiers
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CHUBX 2006/02
Identifier Type: -
Identifier Source: org_study_id