跳至主要内容
临床试验/NCT02899182
NCT02899182已完成1 期

Mixture Nitrous Oxide - Oxygen 50-50% in Transrectal Prostate Biopsy Guided by Ultrasound

Universidade Federal Fluminense1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2016年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
84
试验地点
1
主要终点
Pain reduction in patients undergoing transrectal ultrasound-guided prostate biopsy

研究概览

简要总结

Introduction: Transrectal ultrasound-guided prostate biopsy (TUPB) is the gold standard diagnostic tool for prostate cancer and, though may be well tolerated for some patients, about 65 to 90% of then still complain of discomfort, weather associated or not to pain. Therefore, as a manner of improvement in visual analogic pain score (VAS) and satisfaction between those patients, the aim of this study is to propose the gas mixture N2O-O2 50-50%, as a non-invasive, safe and cost-effective method to deliver analgesia and/or sedation, without the need for an anesthesiologist.

Materials and methods: A randomized clinical trial, simple blind, which took place in Hospital Universitário Antônio Pedro, Niteroi, RJ, within two groups containing 42 patients each, divided in conventional (C), which received 100% oxygen and nitrous oxide (NO), which received inhalation of the mixture N2O-O2 50-50% from a self-demand valve during exam. They were accessed for pain with VAS, answered a satisfaction task and were recorded about collateral side effects.

详细描述

Introduction:

Transrectal ultrasound-guided prostate biopsy (TUGP) is currently the gold standard method used for early cancer diagnosis of this gland, when associated with PSA plasma measurement. Although well tolerated by many patients, about 65-90% of men undergoing BPTU complain of discomfort, associated or not to pain. For better tolerance, various methods of analgesia and / or sedation have been proposed, such as nerve block periprostatic ( or intraprostatic, topical anesthesia with lidocaine or EMLA at the puncture site , general anesthesia with propofol and remifentanil and other invasive techniques.

Inhalation of N2O-O2 50-50% by self-demand valve proposed in this study can be a good alternative to invasive methods to be a safe technique, cost-effective, which promotes analgesia on demand, in order to increase the tolerance painful procedures as TUGP, regardless of the presence of anesthesiologists.

Nitrous oxide (N2O) can be self administered for analgesia in various procedures such as drug joint intra injections, vascular access puncture, flexible sigmoidoscopy and colonoscopy, ophthalmic procedures and prostate biopsy. In Europe it is used in emergencies in the care and transport accidents in ambulances.

The objective is to evaluate the efficiency of inhalation of N2O-O2 50-50% by self-demand valve, comparing it to a placebo group. In addition, investigators evaluated side events such as the adverse effects of administration of nitrous oxide to discuss their security procedures without the presence of anesthesiologist.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

入排标准

性别
Male
接受健康志愿者

入选标准

  • Patients undergoing transrectal prostate biopsy guided by ultrasound

排除标准

  • Patients with failure to report the severity of the pain or unable to inhale through the device .
  • Patients diagnosed with pulmonary hypertension , severe lung disease, or cardiac failure NYHA 3 and 4.

研究组 & 干预措施

conventional group

Placebo Comparator

the conventional group (C) will receive local anesthesia at the puncture site plus inhalation of 100% oxygen a face mask.

干预措施: O2 (Other)

Nitrous Oxide NO

Experimental

The NO group receive local anesthesia at the puncture site plus inhalation N2O-O2 mixture by self-demand valve

干预措施: Nitrous Oxide NO (Drug)

结局指标

主要结局

Pain reduction in patients undergoing transrectal ultrasound-guided prostate biopsy

时间窗: 12 months

Reduction on pain intensity evaluated by EVA scale

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ismar Lima Cavalcanti

Professor

Universidade Federal Fluminense

研究点 (1)

Loading locations...

相似试验