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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Nausea, Vomiting

Intervention / Treatment
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* Drug: Droperidol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Intravenous injection of 0,625 mg Droperidol, 30 min before the end of anesthesia | Drug: Droperidol<br>* Intravenous injection<br>|
| Experimental: 2<br>Intravenous injection of 2,5 mg Droperidol, 30 min before the end of anesthesia | Drug: Droperidol<br>* Intravenous injection<br>|
| Placebo Comparator: 3<br>Intravenous injection of NaCl 9% (Placebo), 30 min before the end of anesthesia | Drug: Droperidol<br>* Intravenous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No vomiting episode |  | During the first four hours after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Light nausea |  | 24h post operative | 
| Control of nausea |  | 24h post operative | 
| Anti-vomiting treatment |  | 24h post operative | 
| Adverse events |  | 24h post operative | 
| Modification of electrocardiograph |  | 30 min and 120 min after injection | 
| - Score of sedation |  | 24h post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroidectomy, Nausea, Vomiting, Droperidol