Non-analgesic Effects Produced by Equipotent Analgesic Doses of Sufentanil, Hydromorphone, and Oxycodone in Female Patients Before Anesthesia Induction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Respiratory rate
研究概览
简要总结
This study aimed to investigate Non-analgesic Effects Produced by Equipotent Analgesic Doses of Sufentanil, Hydromorphone, and Oxycodone in female patients. Methods: A total of 60 patients were randomly divided into 4 groups, with 20 patients in each group. Sufentanil(0.1μg/kg), Hydromorphone(20μg/kg), or Oxycodone(60μg/kg) ,saline(10ml)was administered before anesthesia induction. Bispectral Index (BIS), Respiratory rate(RR), other non-analgesic effects at Tb (entering room), T0 (drug administration), T1 (2min), T2 (4min), T3(6min), T4(8min), T5(10min), T6(20min) were recorded.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists GradeⅠ-II;
- •Patients undergo low-risk elective surgery for benign diseases (including laparoscopic ovarian cyst removal, laparoscopic tubal ligation, laparoscopic tubal drainage, breast operation, thyroid operation, etc) ;
- •Aged 18-45 years;
- •Body Mass Index 18-25kg/m2, weight 40-65 kilograms;
- •Agreed to participate in the research
排除标准
- •Difficult airway;
- •upper respiratory tract infection within 2 weeks;
- •history of allergy or long-term use of propofol and opioids;
- •self-rating anxiety scale before operation indicates anxiety;
- •pregnancy or lactation.
研究组 & 干预措施
Sufentanil
Sufentanil(0.1μg/kg)
干预措施: Sufentanil (Drug)
Hydromorphone
Hydromorphone(20μg/kg）
干预措施: Hydromorphone (Drug)
Oxycodone
Oxycodone(60μg/kg)
干预措施: Oxycodone (Drug)
normal saline
10ml
干预措施: normal Saline (Drug)
结局指标
主要结局
Respiratory rate
时间窗: 20 minutes after administration
Number of breaths per minute
Bispectral Index
时间窗: 20 minutes after administration
bispectral index(BIS): assessing the sedation, placed on the patient's forehead, BIS values 0-100, and the higher score means patients are more conscious
dizziness
时间窗: 20 minutes after administration
a temporary feeling that your sense of balance is not good and that you may fall down
次要结局
- itch(20 minutes after administration)
- nausea or vomiting(20 minutes after administration)
- drowsiness(20 minutes after administration)
- sweating(20 minutes after administration)
研究者
Yanqi
Principal Investigator
Peking University People's Hospital