A Randomized Clinical Trial to Determine the Effect of Transient Postoperative Urinary Retention Using Sugammadex (4 Mg X Kg) Versus Glycopyrrolate and Neostigmine (0.01 Mg/kg - 50mg/kg) in Patients Undergoing Vaginal Hysterectomies with and Without Pelvic Organ Prolapse Procedures: a Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 80
- 主要终点
- Void Test (Pass)
研究概览
简要总结
The Investigator will perform a single-institution randomized double-blinded controlled trial comparing intraoperative Sugammadex vs. standard dose of glycopyrrolate/neostigmine combination for participants undergoing a total vaginal hysterectomy with or without pelvic organ prolapse procedures under general endotracheal anesthesia.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients undergoing a vaginal hysterectomy with the indications of pelvic organ prolapse or abnormal uterine bleeding
排除标准
- •Patients who are already known to have voiding dysfunction
- •Patients who have a contraindication or intolerance to any of the drugs used in the study
- •Has a medical condition or surgical procedure that precludes reversal of neuromuscular block at the end of surgery.
- •Has a neuromuscular disorder(s) that may affect neuromuscular block and/or trial assessments.
- •Is dialysis-dependent or has severe renal insufficiency, defined as estimated creatinine clearance of <30 mL/min.
- •Has or is suspected of having a personal history or family history (parents, grandparents, or siblings) of malignant hyperthermia.
- •Has or is suspected of having an allergy (e.g., hypersensitivity and/or anaphylactic reaction) to study treatments or its/their excipients, to opioids/opiates, muscle relaxants or their excipients, or other medication(s) used during general anesthesia.
- •Has received or is planned to receive toremifene within 24 hours before or within 24 hours after study medication administration.
- •Has any condition that would contraindicate the administration of study medication.
- •Is pregnant, is attempting to become pregnant, or is lactating.
- •Is currently participating in or has participated in an interventional clinical trial (including any other current or ongoing trial with a sugammadex treatment arm) with an investigational compound or device within 30 days of signing the informed consent form of this current trial.
- •Male patients
- •Patients undergoing a conventional laparoscopic or robotic approach
- •Patients having a midurethral sling in addition to the vaginal hysterectomy
- •Patients declining to participate in the study
- •Patients allergic to any of the drugs used in the study (sugammadex, neostigmine and/or glycopyrrolate)
研究组 & 干预措施
Sugammadex
Sugammadex dose=4 mg x kg
干预措施: Sugammadex (Drug)
结局指标
主要结局
Void Test (Pass)
时间窗: Up to 4 hours postop
Number of patients that Pass the Void Test. Once the patients are oriented and before leaving PACU, their bladder will be backfilled with 300 ccs of normal saline or at capacity. Then 30 minutes will be given to void. The voided volume will be measured using a toilet hat, and the post-void residual will then be measured using a bladder scanner.
Void Test (Fail)
时间窗: Up to 4 hours post-op
Number of patients that Fail the Void Test. Once the patients are oriented and before leaving PACU, their bladder will be backfilled with 300 ccs of normal saline or at capacity. Then 30 minutes will be given to void. If the patients are unable to void or if the post-void residual is \> than 100 ml by bladder scanner, then it will be considered that those patients failed the voiding trial
次要结局
未报告次要终点
研究者
Omar Duenas Garcia
Associate Professor
West Virginia University