Use of Sugammadex for Reversal of Paralysis in Microlaryngoscopy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Time to Extubation After End of Procedure
研究概览
简要总结
Use of Muscle relaxant and reversal with Sugammadex at end of airway procedures will reduce the time to extubation after end of procedure
详细描述
This is a prospective, clinical interventional, randomized single blinded single center study.
Hypotheses:
Primary Hypothesis: Use of Muscle relaxant and reversal with Sugammadex at end of airway procedures will reduce the time to extubation after end of procedure
Secondary Hypotheses:
Surgeon will report optimal surgical conditions for ease of exposure
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
- Single (Care Provider)
盲法说明
SINGLE BLIND: The nurses in PACU will be the only evaluators of the subject who will be blinded to the two groups. The PACU nurses will evaluate ALDRETE discharge criteria and make a note in the electronic medical records for the subject discharge time from PACU.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Microlaryngoscopy or rigid bronchoscopy for vocal cord and tracheal procedures
- •Age 18 years or older,
- •ASA physical status I-III
- •Ability to give written informed consent.
排除标准
- •Known or suspected neuromuscular disease/pre-existing weakness,
- •Creatinine clearance less than 30 ml/min
- •Bradycardia of less than 40 beats/min,
- •Pregnancy, breast feeding women
- •Known or suspected allergy to BRIDION® (sugammadex), neostigmine or rocuronium.
- •Patients with contraindications towards sugammadex, neostigmine or rocuronium
- •Patients included in another trial within the last 30 days
- •Patients with legal guardians or surrogate decision making
- •Patients who refuse to use non-hormonal contraceptive method or back-up method of contraception (such as condoms and spermicides) for the next 7 days if receiving sugammadex.
研究组 & 干预措施
Group 1
Reversal of Paralysis in Microlaryngoscopy procedures: Inhaled anesthetics: sevoflurane at 1 MAC, remifentanil and intubation with rocuronium at 0.6-1.2 mg/kg (vitals maintained within 20% of baseline). Standard anti-nausea prophylaxis - Ondansetran and Decadran intraoperative.After induction; amount of inhaled anesthetic and remifentanil used will be titrated based on hemodynamic parameters (maintained within 20% from baseline) and a BIS monitor.TOF testing done every 5 minutes:Group 1 will receive reversal with neostigmine (0.04 mg/kg and glycopyrrolate (0.01 mg/kg)
干预措施: neostigmine (Drug)
Group 1
Reversal of Paralysis in Microlaryngoscopy procedures: Inhaled anesthetics: sevoflurane at 1 MAC, remifentanil and intubation with rocuronium at 0.6-1.2 mg/kg (vitals maintained within 20% of baseline). Standard anti-nausea prophylaxis - Ondansetran and Decadran intraoperative.After induction; amount of inhaled anesthetic and remifentanil used will be titrated based on hemodynamic parameters (maintained within 20% from baseline) and a BIS monitor.TOF testing done every 5 minutes:Group 1 will receive reversal with neostigmine (0.04 mg/kg and glycopyrrolate (0.01 mg/kg)
干预措施: glycopyrrolate (Drug)
Group 2
Reversal of Paralysis in Microlaryngoscopy procedures: Inhaled anesthetics: sevoflurane at 1 MAC, remifentanil and intubation with rocuronium at 0.6-1.2 mg/kg (vitals maintained within 20% of baseline). Standard anti-nausea prophylaxis - Ondansetran and Decadran intraoperative.After induction; amount of inhaled anesthetic and remifentanil used will be titrated based on hemodynamic parameters (maintained within 20% from baseline) and a BIS monitor.TOF testing done every 5 minutes: Group2 will receive reversal with sugammadex 4mg/kg
干预措施: Sugammadex (Drug)
结局指标
主要结局
Time to Extubation After End of Procedure
时间窗: Intraoperative
West Virginia University Hospitals use an electronic medical record (EMR) to chart the end of the procedure. When the surgeon states "We are done", always at withdrawal of the scope, extubation begins. From the time we chart end of procedure to the time of extubation is the extubation time. The start and end times for extubation will be recorded in the EMR.
次要结局
未报告次要终点