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

Nausea Clinical Trial

— DIPAVO  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00445055
• Other study ID #: CHUBX 2006/02
• Status: Terminated
• Phase: Phase 4
• First received: March 6, 2007
• Last updated: December 12, 2011
• Start date: April 2007
• Est. completion date: April 2009

Study information

• Verified date: December 2011
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 71
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 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

Intervention

Drug:
• Droperidol
Intravenous injection

Locations

Country	Name	City	State
France	Département d'Anesthésie-Réanimation II ; Groupe Hospitalier Sud, CHU de Bordeaux	PESSAC Cedex

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Prostrakan Pharmaceuticals

Country where clinical trial is conducted

France, 

References & Publications (5)

Gan TJ, Meyer T, Apfel CC, Chung F, Davis PJ, Eubanks S, Kovac A, Philip BK, Sessler DI, Temo J, Tramèr 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. Review. — View Citation

Henzi I, Sonderegger J, Tramèr 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. Review. — View Citation

Kovac AL. Prevention and treatment of postoperative nausea and vomiting. Drugs. 2000 Feb;59(2):213-43. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No vomiting episode		During the first four hours after intervention	No
Secondary	Light nausea		24h post operative	No
Secondary	Control of nausea		24h post operative	No
Secondary	Anti-vomiting treatment		24h post operative	No
Secondary	Adverse events		24h post operative	Yes
Secondary	Modification of electrocardiograph		30 min and 120 min after injection	Yes
Secondary	- Score of sedation		24h post operative	Yes