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临床试验/NCT02026427
NCT02026427已完成不适用

The Incidence of Urinary Retention in Orthopedic Patients Under Spinal Anesthesia

Military Institute od Medicine National Research Institute1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
time to micturition

研究概览

简要总结

The participants were hospitalized in Orthopedic and Traumatology Departments in Military Institute of Medicine, Warsaw, Poland.

The inclusion criteria were (1) age to 40 year-old, (2) no history of urologic problems, and (3) surgery under spinal anesthesia. All the patients where (1) opioids were administered during the surgery, (2) general anesthesia was necessary, and (3) the urinary bladder catheterization was perform during the surgery were excluded from the study.

The participants were randomly divided into the study and control groups. No oral premedication was administered. All the patients were asked to empty their urinary bladders before arrival to the operating theatre. When the standard monitoring (continuous electrocardiogram, noninvasive blood pressure, pulse oximetry) was started, intravenous premedication with midazolam was administered and lumbar spinal anesthesia with hyperbaric 0.5% solution of bupivacaine hydrochloride was performed.

In the study group, but not in the the control one, the 40 mg of drotaverine hydrochloride was administered intramuscularly. The decresed intravascular volume was corrected with cristalloids. During the surgery the adequate, not deeper than II grade according to Ramsay scale, level of sedationt was obtained with midazolam and/or propofol. All the participants received a questionaire in which we asked the questions about (1) the duration of anesthesia, (2) the time of micturition, (3) the time when discomfort or pain appeared in the lower abdomen, (4) the incidence of the urinary bladder catheterization and time to catheterization. On the next day after the surgery the questionaires were collected. In cases, when the patient's dischaged from the hospital was planned during the weekend, he or she was asked to pass on the questionaire to the nurses.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age below 40 y.o.,
  • surgery under spinal anesthesia,
  • no previous history of urological problems.

排除标准

  • opioid administration during surgery,
  • need for urinary bladder catheterization during surgery,
  • conversion to general anesthesia.

结局指标

主要结局

time to micturition

时间窗: first 24 hours after spinal anesthesia

Time (in minutes) from the administration of spinal anesthesia to spontaneous micturition.

次要结局

  • urinary bladder catheterization(first 24 hours after spinal anesthesia)

研究者

发起方
Military Institute od Medicine National Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dariusz Tomaszewski

MD, PhD

Military Institute od Medicine National Research Institute

研究点 (1)

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