Open Randomized Clinical Trial to Examine Individual Pain Tolerance in the Use of Two Anesthetic Techniques to Perform Saturation Prostate Biopsy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in visual analog scale (VAS)
研究概览
简要总结
To assess the effectiveness of two anesthetic techniques by measuring the pain through visual analog scale (VAS), to obtain saturation prostate biopsies.
详细描述
To assess the effectiveness of two anesthetic techniques by measuring the pain through visual analog scale (VAS), to obtain saturation prostate biopsies.
Anesthetic technique (control) - Intravenous sedation with Midazolam, Fentanile and Ketamine.
Anesthetic technique (intervention) - Regional Mepivacaine infiltration of periprostatic region.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patient
- •Persistence of suspected prostate cancer by altering the prostatic specific antigen and / or digital rectal examination.
- •Two previous negative prostate biopsies .
- •Age < 75 years.
- •Signature of informed consent to perform prostate biopsy.
- •Signature of informed consent for the study.
排除标准
- •Age > 75 years.
- •Absence of consent or refusal to the study .
- •Presence of prostate cancer in previous biopsy observation .
- •Medical-surgical patient's problems, absolutely contraindicating biopsy under local anesthesia.
- •Presence of any allergies to medications involved in the study .
- •Patient's clinical situation that does not allow an outpatient operation and aftercare required .
- •Medical condition of the patient, preventing the realization of outpatient biopsy.
- •No companion.
研究组 & 干预措施
CONTROL
Saturation prostate biopsy under intravenous sedation MIDAZOLAM 1,5 mg per kilogram intravenous, 5 minutes prior to biopsy FENTANILE 0,05 mg per kilogram intravenous, 3 minutes prior to biopsy KETAMINE 0.5 mg per kilogram intravenous, 1 minute prior to biopsy
干预措施: MIDAZOLAM (Drug)
CONTROL
Saturation prostate biopsy under intravenous sedation MIDAZOLAM 1,5 mg per kilogram intravenous, 5 minutes prior to biopsy FENTANILE 0,05 mg per kilogram intravenous, 3 minutes prior to biopsy KETAMINE 0.5 mg per kilogram intravenous, 1 minute prior to biopsy
干预措施: FENTANILE (Drug)
CONTROL
Saturation prostate biopsy under intravenous sedation MIDAZOLAM 1,5 mg per kilogram intravenous, 5 minutes prior to biopsy FENTANILE 0,05 mg per kilogram intravenous, 3 minutes prior to biopsy KETAMINE 0.5 mg per kilogram intravenous, 1 minute prior to biopsy
干预措施: KETAMINE (Drug)
EXPERIMENTAL
Saturation prostate biopsy under local anesthesia MEPIVACAÍNE 2% 10 millimeters periprostatic block at base and ápex, bilaterally.
干预措施: MEPIVACAÍNE (Drug)
结局指标
主要结局
Change in visual analog scale (VAS)
时间窗: 1 hour baseline
Change in visual analog scale (VAS) from baseline and after prostate biopsy
次要结局
- Number of patients with complications after anesthesic procedure and prostate biopsy procedure, after 24 hours of the procedure and at end of study visit. All units will be measured as numbers.(One week)
研究者
José Luis Ponce Díaz-Reixa
MD
Complexo Hospitalario Universitario de A Coruña