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

University Hospital of Bordeaux

Status and phase: Terminated; Phase 4

Conditions: Vomiting; Nausea

Treatments: Drug: Droperidol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00445055

CHUBX 2006/02

Details and patient eligibility

About

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.

Full 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

Enrollment: 71 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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71 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Intravenous injection of 0,625 mg Droperidol, 30 min before the end of anesthesia

Treatment:

Drug: Droperidol

2

Experimental group

Description:

Intravenous injection of 2,5 mg Droperidol, 30 min before the end of anesthesia

Treatment:

Drug: Droperidol

3

Placebo Comparator group

Description:

Intravenous injection of NaCl 9% (Placebo), 30 min before the end of anesthesia

Treatment:

Drug: Droperidol