Evaluation of 2 Doses of Intravenous Droperidol in the Prevention of Postoperative Nausea - Full Text View

Purpose

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.

Condition	Intervention	Phase
Nausea Vomiting	Drug: Droperidol	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting Thyroid Diseases

Drug Information available for: Droperidol

U.S. FDA Resources

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:

No vomiting episode [ Time Frame: During the first four hours after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Light nausea [ Time Frame: 24h post operative ] [ Designated as safety issue: No ]
Control of nausea [ Time Frame: 24h post operative ] [ Designated as safety issue: No ]
Anti-vomiting treatment [ Time Frame: 24h post operative ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: 24h post operative ] [ Designated as safety issue: Yes ]
Modification of electrocardiograph [ Time Frame: 30 min and 120 min after injection ] [ Designated as safety issue: Yes ]
- Score of sedation [ Time Frame: 24h post operative ] [ Designated as safety issue: Yes ]

Enrollment:	71
Study Start Date:	April 2007
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Intravenous injection of 0,625 mg Droperidol, 30 min before the end of anesthesia	Drug: Droperidol Intravenous injection
Experimental: 2 Intravenous injection of 2,5 mg Droperidol, 30 min before the end of anesthesia	Drug: Droperidol Intravenous injection
Placebo Comparator: 3 Intravenous injection of NaCl 9% (Placebo), 30 min before the end of anesthesia	Drug: Droperidol Intravenous injection

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445055

Locations

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

Sponsors and Collaborators

University Hospital, Bordeaux

Prostrakan Pharmaceuticals

Investigators

Study Director:	Gérard JANVIER, MD	University Hospital, Bordeaux
Principal Investigator:	Laure BAUDOUIN, Dr	University Hospital, Bordeaux

More Information

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, 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. 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, 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. Review.

Responsible Party:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT00445055 History of Changes
Other Study ID Numbers:	CHUBX 2006/02
Study First Received:	March 6, 2007
Last Updated:	December 12, 2011
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:

Thyroidectomy
Nausea
Vomiting
Droperidol

Additional relevant MeSH terms:

Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Droperidol
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013

Evaluation of 2 Doses of Intravenous Droperidol in the Prevention of Postoperative Nausea (DIPAVO)