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
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- No vomiting episode
研究概览
简要总结
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.
详细描述
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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?
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Secondary Objective :
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comparison of the % of patients in every group:
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having a complete control of their nausea
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requiring secondarily the appeal to another anti-emetic treatment in postoperative
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presenting an Adverse event
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Compare score of sedation in ach groups
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Evaluate electrocardiograph
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Compare the morphine consumption
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Study design : Prospective, randomized, monocenter, double-blind study
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Inclusion criteria :
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Female
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More than 18 years old
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Patients scheduled for thyroid surgery
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Simplified Apfel score ≥ 2
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ASA score : 1-2
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Informed consent obtained from the patient
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the women in age of procreate must have a reliable contraceptive method
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Exclusion criteria :
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age < 18 years old
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male
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obesity
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present a severe depressive syndrome
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pregnancy women
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trouble of cardiac rate
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alcoholism
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contra-indication for Droperidol prescription
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Study plan: three parallel groups will receive 2 different doses of Droperidol or placebo at the end of surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Age < 18 years old
- •Has a severe depressive syndrome
- •Pregnancy women
- •Trouble with cardiac rate
- •Alcoholism
- •Contra-indication for Droperidol prescription
研究组 & 干预措施
1
Intravenous injection of 0,625 mg Droperidol, 30 min before the end of anesthesia
干预措施: Droperidol (Drug)
2
Intravenous injection of 2,5 mg Droperidol, 30 min before the end of anesthesia
干预措施: Droperidol (Drug)
3
Intravenous injection of NaCl 9% (Placebo), 30 min before the end of anesthesia
干预措施: Droperidol (Drug)
结局指标
主要结局
No vomiting episode
时间窗: During the first four hours after intervention
次要结局
- - Score of sedation(24h post operative)
- Control of nausea(24h post operative)
- Adverse events(24h post operative)
- Modification of electrocardiograph(30 min and 120 min after injection)
- Light nausea(24h post operative)
- Anti-vomiting treatment(24h post operative)