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

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

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.

Study Overview

• Status: Terminated
• Conditions: Nausea; Vomiting
• Intervention / Treatment: Drug: Droperidol

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

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
No vomiting episode	During the first four hours after intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
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
- Score of sedation	24h post operative

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Prostrakan Pharmaceuticals
• Investigators: Study Director: Gérard JANVIER, MD, University Hospital, Bordeaux; Principal Investigator: Laure BAUDOUIN, Dr, University Hospital, Bordeaux

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (ACTUAL): April 1, 2009
• Study Completion (ACTUAL): April 1, 2009

Study Registration Dates

• First Submitted: March 6, 2007
• First Submitted That Met QC Criteria: March 7, 2007
• First Posted (ESTIMATE): March 8, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): December 13, 2011
• Last Update Submitted That Met QC Criteria: December 12, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Nausea; Vomiting; Thyroidectomy; Droperidol
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Adjuvants, Anesthesia; Droperidol
• Other Study ID Numbers: CHUBX 2006/02