Efficacy and Tolerance of Parecoxib for Prevention of Catheter-related Bladder Discomfort in Patients Undergoing Catheterization After TURBT: A Prospective, Randomized, Placebo-controlled, Double-blind Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reducing of Catheter related bladder discomfort symptoms
研究概览
简要总结
Catheter-related bladder discomfort (CRBD) is defined as an urge to void or discomfort in the supra-pubic region; reported postoperatively in patients who have had urinary catheterization intra-operatively. In the present study, the investigators evaluated Parecoxib (P) for preventing CRBD in patients undergoing catheterization after transurethral resection of bladder tumor (TURBT).
详细描述
Participants will be randomized into one of two study groups: Group P: 40 mg of intravenous parecoxib 30 min before surgery and Control Group C: an equal volume of saline.
Lumber subarachnoid block was administered with 2 ml 0.5% hyperbaric bupivacaine and 2.5 µg Sufentanyl. Intra-operatively, urinary catherization was performed with a 16 Fr Foley's catheter, and the balloon was inflated with 10 ml distilled water. The CRBD was assessed at 0, 1, 2, and 6 h after patient's arrival in the post-anaesthesia care unit. Severity of CRBD was graded as none, mild, moderate and severe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (>/=18)
- •Male or female
- •Undergoing catheterization after transurethral resection of bladder tumor (TURBT)
- •Under spinal anesthesia
- •Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2.
排除标准
- •Patient who disagrees to participate this investigation
- •Patient with severe cardiovascular disease
- •Patient with small-sized foley catheter (less than 18 Fr.)
- •Patinets with bladder outflow obstruction
- •Patient with overactive bladder (frequency >3 times,in the night or >8 times in 24 h)
- •Patients with chronic renal failure
- •Patient with morbid obesity
- •Patient with medications for chronic pain
- •Patient with disturbance of the central nervous system
研究组 & 干预措施
Parecoxib
40 mg of intravenous parecoxib (DYNASTAT )30 min before surgery
干预措施: Parecoxib (Drug)
Placebo
An equal volume of saline
干预措施: Placebo (Drug)
结局指标
主要结局
Reducing of Catheter related bladder discomfort symptoms
时间窗: at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours
CRBD was evaluated with a 4 point scale (1; no discomfort, 2; mild, revealed on questioning only, 3; moderate, stated by the patient without questioning, 4; severe, urinary urgency executed by behavioral responses, such as attempts to remove urinary catheter, restless extremity movements, verbal responses) at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours.
次要结局
- Severity of Pain at suprapubic area(at postoperative 0, 1, 6 and 12 hours)
- safety and tolerability of parecoxib(During the first 24 hours)
研究者
Ali JENDOUBI
MD, Assistant Professor
University Tunis El Manar