Surgical Conditions During Vocal Cord Surgery Requiring Jet Ventilation in Patients With Moderate vs. Deep Neuromuscular Block
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Five-point surgical rating scale (SRS)
研究概览
简要总结
The purpose of this study is to determine whether deep neuromuscular blockade provides better surgical conditions than moderate neuromuscular blockade in patients undergoing vocal cord resections requiring jet ventilation.
详细描述
To optimize anatomical exposure and to minimize direct manipulation of local lesions endotracheal intubation often is avoided in patients undergoing vocal cord surgery.
Instead intermittent so called jet ventilation is carried out by using the Hunsaker Mon-jet tube. The safe conduct of these procedures requires full muscle paralysis. In clinical practice, however, deep neuromuscular blockade (NMB) usually cannot be established for this relatively short surgery (<1h) because of an increased risk of prolonged NMB and postoperative ventilation.
The novel neuromuscular blockade reversal agent sugammadex may prove particularly useful in this patient population because it allows fast and reliable reversal of even deep NMB. Deeper muscle paralysis during vocal cord surgery may be associated with better surgical conditions.
The purpose of this study is to determine whether deep neuromuscular blockade provides better surgical conditions than moderate neuromuscular blockade in patients undergoing vocal cord resections requiring jet ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective vocal cord resection with an expected length of the procedure longer than 20 minutes and requiring jet ventilation
排除标准
- •Patients younger than 18 years old
- •Patients unable to give written informed consent
- •Patients with known or suspected neuromuscular disease
- •Patients with allergies to medications to be used during anesthesia
- •Patients with a (family) history of malignant hyperthermia
- •Patients with renal insufficiency (serum creatinine >2 times normal or a glomerular filtration rate <60 ml/h)
研究组 & 干预措施
Moderate neuromuscular blockade (MNB)
The goal is to realize a moderate NMB (TOF 1-2 twitches). NMB will be induced with a bolus dose of rocuronium (Non-depolarizing Skeletal Neuromuscular Blocking Agent). If the target TOF values was not reached bolus doses of rocuronium (5 mg) will be given to achieve the target.
This represents the standard care in our institution for this type of surgery. At the end of surgery, neuromuscular blockade in all patients will be reversed by sugammadex: patients in the moderate neuromuscular blockade group will receive sugammadex (Selective Relaxant Binding Agent).
干预措施: Rocuronium bromide 0.5 mg/kg (Drug)
Moderate neuromuscular blockade (MNB)
The goal is to realize a moderate NMB (TOF 1-2 twitches). NMB will be induced with a bolus dose of rocuronium (Non-depolarizing Skeletal Neuromuscular Blocking Agent). If the target TOF values was not reached bolus doses of rocuronium (5 mg) will be given to achieve the target.
This represents the standard care in our institution for this type of surgery. At the end of surgery, neuromuscular blockade in all patients will be reversed by sugammadex: patients in the moderate neuromuscular blockade group will receive sugammadex (Selective Relaxant Binding Agent).
干预措施: Sugammadex sodium 2 mg/kg (Drug)
Deep neuromuscular blockade (MNB)
The goal is to realize a deep MNB (TOF zero twitches). NMB will be induced with a bolus dose of rocuronium (Non-depolarizing Skeletal Neuromuscular Blocking Agent). If the target TOF values was not reached bolus doses of rocuronium (5 mg) will be given to achieve the target.
At the end of surgery, neuromuscular blockade in all patients will be reversed by sugammadex: patients in the deep neuromuscular blockade group will receive sugammadex (Selective Relaxant Binding Agent).
干预措施: Rocuronium bromide 1.0 mg/kg (Drug)
Deep neuromuscular blockade (MNB)
The goal is to realize a deep MNB (TOF zero twitches). NMB will be induced with a bolus dose of rocuronium (Non-depolarizing Skeletal Neuromuscular Blocking Agent). If the target TOF values was not reached bolus doses of rocuronium (5 mg) will be given to achieve the target.
At the end of surgery, neuromuscular blockade in all patients will be reversed by sugammadex: patients in the deep neuromuscular blockade group will receive sugammadex (Selective Relaxant Binding Agent).
干预措施: Sugammadex sodium 4 mg/kg (Drug)
结局指标
主要结局
Five-point surgical rating scale (SRS)
时间窗: during surgery, an average period of 50 minutes
Surgical conditions during surgery will be assessed by the surgeon using a five-point surgical rating scale at 10 minutes intervals
次要结局
- Drug dosages(Through study completion, an average of 4 hours)
- Time to extubation(During the stay in the operation room, an average of 60 minutes)
- Heart rate(During the stay in the operation and recovery room, an average of 4 hours)
- Arterial blood pressure(During the stay in the operation and recovery room, an average of 4 hours)
- Oxygen saturation(During the stay in the operation and recovery room, an average of 4 hours)
- Respiratory rate(During the stay in the operation and recovery room, an average of 4 hours)
- Body temperature(During the stay in the operation and recovery room, an average of 4 hours)
- Duration of surgery(During the stay in the operation room, an average of 50 minutes)
- Duration of post-anesthesia care unit (PACU) stay(During the stay in the recovery room, an average of 3 hours)
- Pain score(During the stay in the operation and recovery room, an average of 4 hours)
- Occurence of nausea/vomiting(During the stay in the operation and recovery room, an average of 4 hours)
- Sedation(During the stay in the operation and recovery room, an average of 4 hours)
研究者
Thomas Schricker
Professor and Chairman,Department of Anesthesia
McGill University Health Centre/Research Institute of the McGill University Health Centre