Evaluation of 2 Doses of Intravenous Droperidol in the Prevention of Postoperative Nausea
Information source: University Hospital, Bordeaux
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nausea; Vomiting
Intervention: Droperidol (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: University Hospital, Bordeaux Official(s) and/or principal investigator(s): Gérard JANVIER, MD, Study Director, Affiliation: University Hospital, Bordeaux Laure BAUDOUIN, Dr, Principal Investigator, Affiliation: University Hospital, Bordeaux
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: No vomiting episode
Secondary outcome: Light nauseaControl of nausea Anti-vomiting treatment Adverse events Modification of electrocardiograph - Score of sedation
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Département d'Anesthésie-Réanimation II ; Groupe Hospitalier Sud, CHU de Bordeaux, PESSAC Cedex 33604, France
Additional Information
Related publications: Kovac AL. Prevention and treatment of postoperative nausea and vomiting. Drugs. 2000 Feb;59(2):213-43. Review. 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. Gan TJ, Meyer T, Apfel CC, Chung F, Davis PJ, Eubanks S, Kovac A, Philip BK, Sessler DI, Temo J, Tramèr 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. Review. 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. Henzi I, Sonderegger J, Tramèr 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. Review.
Starting date: April 2007
Last updated: December 12, 2011
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