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

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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00445055
Acronym
DIPAVO
Enrollment
71
Registered
2007-03-08
Start date
2007-04-30
Completion date
2009-04-30
Last updated
2011-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea, Vomiting

Keywords

Thyroidectomy, Nausea, Vomiting, Droperidol

Brief 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.

Detailed 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

Interventions

Intravenous injection

Sponsors

Kyowa Kirin Co., Ltd.
CollaboratorINDUSTRY
University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
No vomiting episodeDuring the first four hours after intervention

Secondary

MeasureTime frame
Control of nausea24h post operative
Anti-vomiting treatment24h post operative
Light nausea24h post operative
Modification of electrocardiograph30 min and 120 min after injection
- Score of sedation24h post operative
Adverse events24h post operative

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026