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

Nausea Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

• Nausea
• Vomiting

• NCT number: NCT00445055
• Study type: Interventional
• Source: University Hospital, Bordeaux
• Status: Terminated
• Phase: Phase 4
• Start date: April 2007
• Completion date: April 2009