Sugammadex Compared With Neostigmine/Glycopyrrolate in Impact of Postoperative Urinary Retention for ENT Surgery Patients With High-risk of Dysuria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- postoperative urinary retention
研究概览
简要总结
The aim of study is to clarify the role of sugammadex in ENT surgery patients with a prior history of postoperative urinary retention, benign prostatic hypertrophy, or a history of prostate cancer, to prevent postoperative urinary retention. The main question it aims to answer are:
- Anticholinergic agent interferes the postoperative urination
- Sugammadex does not interfere postoperative urination Sugammadex can be recommended for these patients with high risk in postoperative urinary retention in the future.
详细描述
Investigators will evaluate the benefit of sugammadex in reducing postoperative urinary retention for these head and neck surgery patients with high-risk for dysuria. The definition of high-risk of dysuria is patient with a prior history of urinary retention, benign prostatic hypertrophy, or a history of prostate cancer.
Patients scheduled to undergo ENT surgery within Three hours of expected surgical time are enrolled. These patients are associated with high-risk of postoperative urinary retention, including prior history of postoperative urinary retention, benign prostatic hypertrophy, or a history of prostate cancer. They are randomly divided these patients into sugammadex group (Group S) and neostigmine/glycopyrrolate group (Group N), sugammadex or neostigmine/glycopyrrolate are used during recovery period of anesthesia, to compare the incidences of postoperative urinary retention, nausea/vomiting, bradycardia, hypotension, and dry mouth in these patients after ENT surgery. Sugammadex can be recommended for these high-risk patients in the future.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ENT surgery patients whose surgery is expected to take less than three hours and no planned Foley catheter
- •high risk of postoperative urinary retention, including
- •prior history of postoperative urinary retention
- •benign prostatic hypertrophy
- •history of prostate cancer
排除标准
- •refusal or inability to provide informed consent
- •age younger than 18 years
- •American Society of Anesthesiologists class more than III
- •pregnancy
- •impaired renal function (creatinine clearance < 30 mL/min)
- •allergy to a study drug
结局指标
主要结局
postoperative urinary retention
时间窗: up to 48 hours
Postoperative urinary retention is defined as patient discomfort or a palpable bladder, with a bladder volume of ≥400 mL confirmed by bladder scan or catheterization, requiring intervention.
postoperative urinary retention
时间窗: up to 48 hours
Postoperative urinary retention is defined as patient discomfort or a palpable bladder, with a bladder volume of ≥400 mL confirmed by bladder scan or catheterization, requiring intervention.
次要结局
- length of hospital stay(during admission (assessed up to 7 days))
- postoperative nausea and vomiting(48 hours)
- bradycardia(24 hours)
- thirsty intensity(24 hour)