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.

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

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

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.