Evaluation of 2 Doses of Intravenous Droperidol in the Prevention of Postoperative Nausea
Evaluation of 2 Doses of Intravenous Droperidol in the Prevention of Postoperative Nausea
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