Reversal of Neuromuscular Blockade in Patients With Severe Renal Impairment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Time Until Complete Reversal of Neuromuscular Blockade
研究概览
简要总结
This study is intended to be a single-site, prospective, randomized, double-blinded study that intends to enroll a total of 60 patients with severe renal impairment undergoing surgery with general endotracheal anesthesia at Parkland Hospital. Patients will be randomized to receive either neostigmine (for reversal of cisatracurium) or sugammadex (for reversal of rocuronium). 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. All patients will be monitored with continuous pulse oximetry postoperatively for 24 hours.
详细描述
This will be a prospective, randomized, double-blinded study of surgical patients with severe renal impairment that seeks to address the following:
Specific Aim:
To determine whether rocuronium-induced moderate neuromuscular blockade and reversal with sugammadex achieves recovery of neuromuscular function (TOF ≥ 0.9) faster than reversal of cisatracurium-induced moderate neuromuscular blockade and reversal with neostigmine in patients with severe renal impairment.
Primary Hypothesis:
Patients with severe renal impairment who are reversed with sugammadex after rocuronium will achieve a TOF ≥0.9 within a time frame that is one-third of the time it takes for reversal with neostigmine after cisatracurium.
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
double 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
- •Severe renal impairment (CrCl < 30 mL/min)
- •Undergoing non-emergent surgery that requires neuromuscular blockade
- •Planned extubation in the operating room immediately after surgery
- •American Society of Anesthesiologists (ASA) physical status classification 3 to 4
- •Willing and able to consent in English or Spanish
- •No personal history of neuromuscular disease
排除标准
- •Age less than 18 or older than 80
- •Patient does not speak English or Spanish
- •Planned postoperative intubation/ventilation
- •Allergy to sugammadex, neostigmine, glycopyrrolate, cisatracurium, or rocuronium
- •Family or personal history of malignant hyperthermia
- •Patient refusal
- •Pregnant or nursing women
- •"Stat" (emergent) cases
- •Pre-existing muscle weakness of any etiology
- •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
Cisatracurium + Neostigmine
Patients in the cisatracurium/neostigmine group will receive 0.2 mg/kg of cisatracurium for neuromuscular paralysis during induction. Additional cisatracurium will be given to keep the patient at a neuromuscular depth of 1 twitch throughout the surgery until the last 30 minutes, during which the patient will be kept at 2 twitches.
干预措施: Cisatracurium + Neostigmine (Drug)
Rocuronium + Sugammadex
Patients in the rocuronium/sugammadex group will receive 0.6 mg/kg of rocuronium for neuromuscular paralysis during induction. Additional rocuronium will be given to keep the patient at a neuromuscular depth of 1 twitch throughout the surgery until the last 30 minutes, during which the patient will be kept at 2 twitches.
干预措施: Rocuronium + Sugammadex (Drug)
结局指标
主要结局
Time Until Complete Reversal of Neuromuscular Blockade
时间窗: In the operating room, the amount of time after administration of the reversal syringe to reach recovery of neuromuscular function (TOFR ≥ 90%) assessed up to 30 minutes.
Measure how long it takes to return from a TOF of 2 to a TOF ≥ 0.9.
次要结局
未报告次要终点
研究者
Tiffany B Moon
ASSOC PROFESSOR
University of Texas Southwestern Medical Center