A Randomised Controlled Trial Comparing Combined Intravenous Propofol and Fentanyl Versus Intravenous Propofol Alone for Sedation in Patients Undergoing Transrectal Ultrasound-guided (TRUS) Prostate Biopsy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Pain assess using Numeric rating scale (NRS) score
研究概览
简要总结
Nowadays, TRUS biopsy become one of the most popular tests for diagnosis of prostate cancer. This procedure causes pain to the patients who does not received the sedative drugs or analgesic drugs. There are many ways to reduce pain and inconvenience for the patients, such as intravenous propofol, intravenous fentanyl etc. In Siriraj hospital, anesthesiologists usually give intravenous propofol with intravenous opioids but the visual analogue score after this procedure was average at 0.9-2.9. Furthermore, some systematic reviews have shown that there was no difference in pain score between periprostatic nerve block plus opioid and periprostatic nerve block only. So, this study is to find out whether opioids is need for TRUS biopsy.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age over 18 year
- •Patient American society of anesthesiology physical status I-III.
- •Scheduled for Transrectal ultrasound-guided prostate biopsy
- •BMI equal to or less than 30 kg/cm2
排除标准
- •Known hypersensitivity to propofol or fentanyl
- •History of bleeding tendency
- •Known case of active anal or rectal disease
- •Unable to rate pain score
- •History of drug abuse
- •Chronic opioid use
研究组 & 干预措施
Control
normal saline IV plus propofol infusion
干预措施: Control (Other)
Control
normal saline IV plus propofol infusion
干预措施: propofol (Drug)
Fentanyl
0.5 mcg/kg ideal body weight IV plus propofol infusion
干预措施: Fentanyl (Drug)
Fentanyl
0.5 mcg/kg ideal body weight IV plus propofol infusion
干预措施: propofol (Drug)
结局指标
主要结局
Pain assess using Numeric rating scale (NRS) score
时间窗: 20 minutes
次要结局
- Number of participants with hypoxia defined as oxygen saturation <92%(60 minutes)
- Number of participants with hypotension, defined as systolic blood pressure <90 mmHg(60 minutes)
研究者
Sirilak Suksompong
Associate Professor
Mahidol University