Determation of Median Effective Dose of Propofol Combined With Different Dose of Esketamine Inhibiting Response to Laryngeal Mask Airway Insertion in Female Patients
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Record related indicators
研究概览
简要总结
Objective To prospectively determine the median effective dose (ED50) of propofol for inhibiting a response to laryngeal mask airway (LMA) insertion when combined with different doses of esketamine in female patients.
Methods Fifty-eight female patients (aged 20-60, ASAⅠ-Ⅱ) scheduled for elective hysteroscopy were enrolled and randomly divided into two groups, one administered 0.2 mg/kg of esketamine (K1 group, n = 28) and the other 0.3 mg/kg of esketamine (K2 group, n = 30). The two groups received the corresponding doses of esketamine intravenously, followed by an intravenous injection of propofol (injection time was 30 s). The initial dose of propofol was 2 mg/kg, and the dose ratio of propofol in the adjacent patients was 0.9. If there was a positive reaction to LMA insertion, the dose ratio in the next patient was increased by one gradient, and if not, the dose ratio was decreased by one gradient. The median effective dose (ED50), 95% effective dose (ED95) and 95% confidence interval (95%CI) of propofol for inhibiting a response to LMA insertion in the two esketamine groups were calculated using a probit analysis.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women undergoing gynaecological hysteroscopy and surgery resulting from any indication
- •age: from 20 to 60 years old
- •body mass index (BMI): 18-30 kg/m2
- •American Society of Anesthesiologists Physical Status score: grade I-II
- •voluntary participation in this study
排除标准
- •pregnant and lactating women
- •patients with a history of propofol allergy, uncontrolled hypertension, hyperthyroidism, severe cardiopulmonary diseases, airway stenosis and mental diseases
- •those who have recently taken or are taking psychotropic drugs or analgesic drugs
- •patients allergic to or addicted to esketamine
研究组 & 干预措施
K1
a group administered 0.2 mg/kg of esketamine
干预措施: Esketamine 0.2mg/kg (Drug)
K2
a group administered esketamine of 0.3 mg/kg (K2)
干预措施: Esketamine 0.3mg/kg (Drug)
结局指标
主要结局
Record related indicators
时间窗: 2minutes
heart rate (HR)
Overall condition of LMA placement
时间窗: 1 minutes
mouth opening ≥3 cm is complete and \<3 cm is incomplete. The LMA placement conditions are as follows: 1 = complete relaxation, 2 = mild resistance, 3 = resistance but can open the mouth, 4 = resistance and the need to further increase the propofol dose; 1 and 2 are considered successful LMA placement and 3 and 4 are failure
Record of the patient response during LMA placement
时间窗: 1 minutes
body movement or no body movement. Body movement is defined as cough, breath-holding or laryngospasm when the LMA is inserted or the laryngeal cuff inflated, and the patient has difficulty opening the mouth and conscious movement all over the body. No body movement is defined as the absence of these reactions when the LMA is inserted or the laryngeal cuff is inflated.
Record of additional doses of propofol and the adverse reactions of positive patients during the induction process (hypotension, bradycardia and apnoea, etc.)
时间窗: 1 minutes
If the patient develops bradycardia (\<45 beats/min), 0.3-0.5 mg of intravenous atropine is given, and 1-2 mg of intravenous dopamine is administered for hypotension (\<20% of basal blood pressure)
次要结局
未报告次要终点