A Pilot Study Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery From Ambulatory Surgery
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Total Consumption of Fentanyl
研究概览
简要总结
A pilot study to evaluate the effect of incorporating sublingual sufentanil into our perioperative opioid regimen for ambulatory orthopedic surgery.
详细描述
A pilot study to evaluate the effect of incorporating sublingual sufentanil into our perioperative opioid regimen for ambulatory orthopedic surgery. The results will help us estimate treatment effect and determine sample size for a subsequent full-scale clinical trial.
Primary Endpoint: total amount of fentanyl consumed during hospital admission. Secondary Endpoints: 1) phase I recovery time; and, 2) time to fitness for discharge.
Exploratory Endpoints: 1) intraoperative hemodynamics; 2) intraoperative opioid use; 3) intraoperative sevoflurane use; 4) postoperative pain; 5) postoperative sedation and cognitive recovery 6) time to first request for analgesia; and, 7) incidence of nausea and vomiting between the end of anesthesia and hospital discharge.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older;
- •Scheduled for elective knee arthroscopy without anticipated ligamentous repair;
- •Planned general anesthesia without a regional block or wound infiltration with local anesthesia;
- •Planned day-of-surgery discharge.
排除标准
- •Opioid tolerance defined by ≥15 mg of oral morphine daily or equianalgesic dose of another opioid within 30 days of surgery;
- •Known hypersensitivity to sufentanil or components of DSUVIA;
- •Patients with an allergy or hypersensitivity to opioids;
- •Pregnancy or actively breastfeeding;
- •Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days of the first dose of study drug;
- •Patients with a medical condition that, in the Investigator's opinion, could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments, including chronic pain or active infection.
研究组 & 干预措施
Intervention Group
30 µg tablet of sublingual sufentanil preoperatively and fentanyl placebo at induction of anesthesia.
干预措施: Sufentanil (Drug)
Control Group
placebo sublingual sufentanil preoperatively and 50 µg fentanyl at induction of anesthesia
干预措施: Fentanyl (Drug)
结局指标
主要结局
Total Consumption of Fentanyl
时间窗: About 3 hours in PACU
The total amount of fentanyl consumed in PACU.
次要结局
- Phase 1 Recovery Time(1.5 hours)
- Time to Fitness for PACU Discharge(1 - 2 hours.)