Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 235
- 试验地点
- 1
- 主要终点
- Number of Participants With Postoperative Urinary Retention (POUR) of Sugammadex and Neostigmine Groups
研究概览
简要总结
This study is intended to be a single-site, prospective, randomized, controlled study that intends to enroll a total of 230 patients undergoing laparoscopic cholecystectomy at Parkland Hospital. Patients will be randomized to receive either neostigmine or sugammadex for reversal of rocuronium-induced neuromuscular blockade. A standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. The remainder of the anesthetic care of the subject will not deviate from the standard of care. To account for protocol deviations and patient dropout, up to 250 randomization envelopes will be made and enrollment will continue until there are 230 completed enrollments.
详细描述
Objective
To determine the incidence of postoperative urinary retention after reversal of rocuronium-induced neuromuscular blockade by neostigmine versus sugammadex in patients undergoing laparoscopic cholecystectomy.
Hypothesis
Subjects who are reversed with sugammadex will have less postoperative urinary retention compared to subjects who are reversed with neostigmine.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Blinded
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-80 years old
- •Undergoing laparoscopic cholecystectomy
- •Anticipated surgical duration <2 hours
- •ASA physical status classification 1-3
- •Willing and able to consent in English or Spanish
- •No personal history of neuromuscular disease
排除标准
- •Preoperative urinary catheter
- •History of problems with urination
- •Current use of anticholinergic medications (e.g., antihistamines, phenothiazines, antidepressants, antipsychotics)
- •Current UTI or urogenital problem (incontinence, known bladder retention, prostate hypertrophy)
- •Planned intraoperative insertion of a urinary catheter
- •ESRD (GRF <30 mL/min)
- •ESLD (AST or ALT > 3x reference range)
- •Planned postoperative intubation/ventilation or admission to ICU
- •Allergy to sugammadex, neostigmine, glycopyrrolate, or rocuronium
- •Pregnant or nursing women
- •"Stat" (emergent) cases
- •Known or suspected neurological condition (e.g., Alzheimer's, h/o of stroke, multiple sclerosis, Parkinson's)
- •Patients on toremifene (a selective estrogen receptor modulator)
- •Women on oral contraceptives who do not wish to use a non-hormonal method of contraception for 7 days following surgery
研究组 & 干预措施
Neostigmine
One type of Neuromuscular Blockade Reversal Drug
干预措施: Neostigmine (Drug)
Sugammadex
One type of Neuromuscular Blockade Reversal Drug
干预措施: Sugammadex (Drug)
结局指标
主要结局
Number of Participants With Postoperative Urinary Retention (POUR) of Sugammadex and Neostigmine Groups
时间窗: In the post-operative anesthesia care unit, bladder volumes and time to void were measured, assessed up to 24 hours or patient discharge.
Measure pre- and post-void bladder volumes, void volume, and the time to void after operation. The count of participants with Postoperative Urinary Retention (POUR) of Sugammadex and Neostigmine Groups is being reported. POUR will be defined as: 1. Inability to spontaneously urinate and a bladder volume ≥ 300 mL 2. Postvoid residual \> 150 mL 3. Need for insertion of Foley catheter or straight catheter
次要结局
未报告次要终点
研究者
Tiffany B Moon
Associate Professor
University of Texas Southwestern Medical Center