Preoperative Education With Image Illustrations Enhances the Effect of Tetracaine Mucilage in Alleviating Postoperative Catheter-related Bladder Discomfort: a Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- The incidence of postoperative CRBD
研究概览
简要总结
Catheter-related bladder discomfort (CRBD) is not uncommon in male patients under general anesthesia, and it may cause patient agitation and exacerbated postoperative pain. In this study, the investigators will enroll male patients undergoing elective colonal and rectal surgery with surgical duration of at least 2 h, requiring catheterization of the urinary bladder with urinary catheterization after anesthetic induction, and compare preoperative education with image illustrations combined with local tetracaine mucilage vs. local tetracaine mucilage alone in alleviating CRBD during the post-operative period.
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 (Care Provider, Outcomes Assessor)
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
- •Patients aged 18 years to 75 years.
- •American Society of Anesthesiologists (ASA) physical status I, II.
- •Undergoing elective noncardiac surgery with urinary catheterization after 4.anesthetic induction under general anesthesia.
- •5.Duration of surgery more than 2h 6.Glasgow Coma Scale (GCS) score of
- •Ability to communicate.
排除标准
- •History of bladder dysfunction, such as over active bladder (OAB, urinary frequency: more than three times in the night or more than eight times in 24 h).
- •History of bladder outflow obstruction.
- •Neurogenic bladder.
- •Impaired renal function.
- •Coagulopathy.
- •Known allergies to any anesthetic agent.
- •Family history of malignant hyperthermia.
- •Impairment of communication or cognition.
- •Psychopathy.
- •Active participation in another trial where the primary endpoint follow-up is ongoing.
- •Unwillingness or inability to comply with protocol procedures.
研究组 & 干预措施
preoperative education and tetracaine
干预措施: Preoperative education with image illustrations and/or local tetracaine mucilage (Other)
tetracaine
干预措施: Preoperative education with image illustrations and/or local tetracaine mucilage (Other)
结局指标
主要结局
The incidence of postoperative CRBD
时间窗: 6 hours
The incidence of postoperative CRBD; CRBD was assessed according to the following scaling system: no CRBD; mild CRBD (complaint about CRBD on questioning only); moderate CRBD (complaint about CRBD without enquiring); and severe CRBD (complaint about CRBD without enquiring, with urinary urgency demonstrated by a spontaneous behavioural response such as flailing limb, verbal responses, or attempt to remove the catheter)
次要结局
- The incidence of emergence agitation(6 hours)
- The incidence of postoperative pain(6 hours)
- The severity of postoperative pain(6 hours)
- Incidenc of adverse events(6 hours)
- The severity of postoperative CRBD(6 hours)
研究者
Chunling Jiang
Professor
West China Hospital