Median Effective Dose of Remifentanil for the Prevention of Pain Caused by the Injection of Rocuronium
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The appearance of intravenous injection pain Yes or No
研究概览
简要总结
As a medium-and long-term non-depolarizing muscle relaxant, rocuronium has the advantages of quick effect, no histamine release and accumulation and no obvious cardiovascular adverse reactions, so it has been widely used in clinical anesthesia induction. However, when given intravenously, rocuronium can cause adverse reactions such as injection pain and limb retraction, which can lead to needle prolapse, extravasation of injection drugs, swelling of injection site, serious induction delay, and cardiovascular adverse events in severe cases. Remifentanil is a synthetic opioid drug hydrolyzed by esterase. Compared with other opioid drugs, remifentanil has the advantages of quick effect, short half-life and short time of hemodynamic changes, so it is an ideal analgesic in clinical anesthesia. In this study, in order to provide clinical references, sequential method was used to find the median effective dose (ED50) by means of pre-intravenous injection of Remifentanil to suppress pain in rocuronium injection.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages ranged from 18 to
- •ASA # or # level.
排除标准
- •Allergy or contraindication to remifentanil or rocuronium; required for Central venipuncture catheterization;
- •Abnormal liver or kidney function;
- •Heavy drinking and long-term use of sedatives, analgesics or anti-anxiety drugs;
- •Hearing and language impairment;
- •Peripheral vascular disease;
- •Severe cardiovascular disease or neurological disorders;
- •Failure of one-time peripheral venipuncture;
- •Infection of hand or wrist skin.
研究组 & 干预措施
Age range of 18 to 44 years olds
The initial dose of lidocaine for pre-injection was set at 1ug/kg according to previous literature and preliminary test results. The dose of remifentanil was according to the patients' pain level. If there is no pain (negative reaction), the dose of remifentanil in the next patient will be reduced until the patient has pain. If there is pain (positive reaction), the dose of remifentanil will be increased in the next patient until the patient is painless.
干预措施: Remifentanil (Drug)
Age range of 45 to 59 years olds
The initial dose of lidocaine for pre-injection was set at 1ug/kg according to previous literature and preliminary test results. The dose of remifentanil was according to the patients' pain level. If there is no pain (negative reaction), the dose of remifentanil in the next patient will be reduced until the patient has pain. If there is pain (positive reaction), the dose of remifentanil will be increased in the next patient until the patient is painless.
干预措施: Remifentanil (Drug)
Age range of 60 to 80 years olds
The initial dose of lidocaine for pre-injection was set at 1ug/kg according to previous literature and preliminary test results. The dose of remifentanil was according to the patients' pain level. If there is no pain (negative reaction), the dose of remifentanil in the next patient will be reduced until the patient has pain. If there is pain (positive reaction), the dose of remifentanil will be increased in the next patient until the patient is painless.
干预措施: Remifentanil (Drug)
结局指标
主要结局
The appearance of intravenous injection pain Yes or No
时间窗: an average of 2 minutes
Yes or No
次要结局
- The levels of intravenous injection pain(an average of 2 minutes)
研究者
Zhuan Zhang
Director
Yangzhou University