Clinical trial NCT00445055: Evaluation of 2 Doses of Intravenous Droperidol in the Prevention of Postoperative Nausea
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Nausea
Vomiting
Keywords: Thyroidectomy
Nausea
Vomiting
Droperidol
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Kyowa Kirin Co., Ltd.
First posted: 2007-03-08
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: No vomiting episode
timeFrame: During the first four hours after intervention
Secondary outcomes:
measure: Light nausea
timeFrame: 24h post operative
measure: Control of nausea
timeFrame: 24h post operative
measure: Anti-vomiting treatment
timeFrame: 24h post operative
measure: Adverse events
timeFrame: 24h post operative
measure: Modification of electrocardiograph
timeFrame: 30 min and 120 min after injection
measure: - Score of sedation
timeFrame: 24h post operative
Other outcomes:
Locations:
city: PESSAC Cedex
country: France
facility: Département d'Anesthésie-Réanimation II ; Groupe Hospitalier Sud, CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Gérard JANVIER, MD
role: STUDY_DIRECTOR
affiliation: University Hospital, Bordeaux
name: Laure BAUDOUIN, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kovac AL. Prevention and treatment of postoperative nausea and vomiting. Drugs. 2000 Feb;59(2):213-43. doi: 10.2165/00003495-200059020-00005.
citation: 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.
citation: 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.
citation: 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.
citation: 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.