Antagonism Research Between Antiemetics Agents (Droperidol, Dexametasone, Ondansetron) and Acetaminophen in Thyroidectomy's Post-operative Analgesia.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- "electric nociception threshold" measured by PainMatcher
研究概览
简要总结
The purpose of our study is to determine if there is an antagonism between drugs used in the prevention of postoperative nausea and vomiting (PONV) on the analgesia led by acetaminophen after thyroidectomy.
详细描述
It was shown that there was an antagonism of the ondansetron on the analgesia led by acetaminophen in a model of nociception by electrical stimulation using the PainMatcher in healthy volunteers. Our study try to determinate if a such antagonism exist in clinical conditions : 66 patients with an Apfel-score II undergoing thyroidectomy were randomized in 3 equal groups. Each group received an antiemetic (ondansetron, droperidol or dexamethasone) at the begining of the intervention and paracetamol at the end of the intervention for the postoperative analgesia. During 2 hours in the postoperative unit, we raised : the electrical pain's threshold with the PainMatcher, the numeric pain intensity scale and the presence of nausea or vomiting. For each patients we determined the cytochrome P450 2D6 activity that should have been able to explain a diminution of ondansetron's efficiency. Paracetamol blood levels were also raised in the postoperative unit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing thyroidectomy without lymph node dissection
- •American Society of Anesthesiologists physical status from I to III
- •Apfel-score equal to 2
- •informed consent signed
排除标准
- •pregnant and breast-feeding women
- •addictive disorders
- •psychic diseases
- •allergy or contra-indication to a drug used in the study
- •presence of postoperative nausea or vomiting
- •administration of glucocorticoid for protecting recurrent laryngeal nerve.
- •protocol not respected
- •protocol refused by the patient
- •intellectual handicap
研究组 & 干预措施
ONDANSETRON (OS)
patients receiving ondansetron at the beginning of the surgery to prevent postoperative nausea and vomiting (PONV); and paracetamol at the end of the surgery for postoperative analgesia.
干预措施: ondansetron (Drug)
DROPERIDOL (DRO)
patients receiving droperidol at the beginning of the surgery to prevent PONV; and paracetamol at the end of the surgey for postoperative analgesia.
干预措施: Droperidol (Drug)
DEXAMETHASONE (DEXA)
patients receiving dexamethasone at the beginning of the surgery to prevent PONV; and paracetamol at the end of the surgey for postoperative analgesia.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
"electric nociception threshold" measured by PainMatcher
时间窗: during 2 hours after thyroidectomy in the postoperative care unit
The PainMatcher is a pain self-assessment device using the electric stimulation of the median nerve. The patient maintains a pressure on an electrode box between the thumb and the index finger, creating a current of increasing intensity. The threshold of pain sensation is obtained when the patient releases his fingers from the electrode box. So whe raise the electric nociceptive threshold showned by the PainMatcher. We realize two measures and consider the second one. objective measure.
次要结局
- presence of postoperative nausea and vomiting(during the 2 hours after thyroidectomy in the postoperative care unit)
- need in rescue analgesia with nefopam in case of numeric rating scale score > 4(during 2 hours after thyroidectomy in the postoperative care unit)
- numeric rating scale score(during 2 hours after thyroidectomy in the postoperative care unit)