REMIfentanil (2 vs. 4 mcg/kg) Facilitated Intubation Without Neuromuscular Blockade Versus Succinylcholine and Rocuronium With Sugammadex for Endotracheal Intubation in Spine Surgery Requiring Motor Evoked Potential Monitoring
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Clinically Acceptable Intubating Conditions
研究概览
简要总结
The purpose of this research is to compare four commonly used anesthesia medication strategies for placing a breathing tube in patients undergoing spine surgery that requires motor evoked potential (MEP) monitoring.
详细描述
Specifically, the study will compare two different doses of remifentanil, succinylcholine, and rocuronium followed by sugammadex to determine which approach provides the best conditions for endotracheal intubation while minimizing interference with nerve monitoring. Researchers will also evaluate how these approaches affect blood pressure and heart rate during anesthesia induction, the quality of motor evoked potential monitoring, the need for additional airway interventions or rescue medications, and the occurrence of side effects such as muscle soreness after surgery.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Scheduled for elective spine surgery (cervical, thoracic, or lumbar) requiring intraoperative MEP monitoring
- •Able to provide written informed consent
排除标准
- •Known or suspected difficult airway (Mallampati class IV, history of difficult intubation, limited mouth opening < 3 cm, limited neck extension)
- •Body mass index (BMI) > 40 kg/m2
- •Known allergy or hypersensitivity to remifentanil, succinylcholine, rocuronium, sugammadex, or propofol
- •Personal or family history of malignant hyperthermia
- •Known or suspected pseudocholinesterase deficiency
- •Conditions predisposing to succinylcholine-induced hyperkalemia (e.g., major burns within the last year, denervation injuries or upper motor neuron lesions within 6 months, severe crush injuries, prolonged immobilization > 72 hours, known hyperkalemia > 5.5 mEq/L)
- •Severe preoperative motor deficit (manual muscle testing ≤ 2/5 in monitored extremities)
- •Neuromuscular disorders (e.g., myasthenia gravis, muscular dystrophy, Guillain-Barre syndrome, prior stroke with residual motor deficits)
- •Severe cardiovascular disease (e.g., ejection fraction < 30%, unstable angina, myocardial infarction within 3 months)
- •Severe bradycardia (heart rate < 50 bpm) or high-grade atrioventricular block without a pacemaker
- •Current use of medications affecting neuromuscular function (aminoglycosides, magnesium infusion, certain antiepileptic meds, etc.)
- •Emergency surgery
- •High aspiration risk (e.g., uncontrolled gastroesophageal reflux disease)
- •Pregnancy or breastfeeding
研究组 & 干预措施
Low-Dose Remifentanil
Participants receive remifentanil 2 mcg/kg intravenous bolus after standardized propofol induction.
干预措施: Low-Dose Remifentanil (Drug)
High-Dose Remifentanil
Participants receive remifentanil 4 mcg/kg intravenous bolus after standardized propofol induction.
干预措施: High-Dose Remifentanil (Drug)
Succinylcholine Control
Participants receive succinylcholine 1 mg/kg intravenous bolus after standardized propofol induction.
干预措施: Succinylcholine (Drug)
Rocuronium With Sugammadex
Participants receive rocuronium 0.6 mg/kg intravenous bolus after standardized propofol induction, followed by sugammadex reversal after intubation according to protocol.
干预措施: Sugammadex (Drug)
Rocuronium With Sugammadex
Participants receive rocuronium 0.6 mg/kg intravenous bolus after standardized propofol induction, followed by sugammadex reversal after intubation according to protocol.
干预措施: Rocuronium (Drug)
结局指标
主要结局
Percentage of Participants With Clinically Acceptable Intubating Conditions
时间窗: During the first endotracheal intubation attempt after study drug administration, assessed within approximately 10 minutes after induction of anesthesia
Clinically acceptable intubating conditions are defined as intubating conditions rated as excellent or good using a standardized intubating conditions assessment. The assessment includes ease of laryngoscopy, vocal cord position and movement, and participant reaction to intubation. Overall intubating conditions are categorized as excellent, good, or poor. Excellent and good conditions will be counted as clinically acceptable, and poor conditions will be counted as not clinically acceptable. The outcome will be reported as the percentage of participants in each arm with clinically acceptable intubating conditions.
次要结局
- Number of Laryngoscopy Attempts(During endotracheal intubation after study drug administration, assessed within approximately 10 minutes after induction of anesthesia)
- Percentage of Participants With Excellent Intubating Conditions(During the first endotracheal intubation attempt after study drug administration, assessed within approximately 10 minutes after induction of anesthesia)
- Percentage of Participants With Successful First-Attempt Endotracheal Intubation(Within 5 minutes after the study drug administration.)
- Cormack-Lehane Grade of Glottic Visualization grade(During the first laryngoscopy attempt after study drug administration.)
- Intubation Difficulty Scale Score(During endotracheal intubation after study drug administration, assessed within approximately 10 minutes after induction of anesthesia)
- Time From Study Drug Administration to Successful Endotracheal Intubation(From study drug administration until successful endotracheal intubation, assessed within approximately 10 minutes after induction of anesthesia)
- Percentage of Participants Requiring Rescue Neuromuscular Blockade(During attempted endotracheal intubation after study drug administration, assessed within approximately 10 minutes after induction of anesthesia)
- Percentage of Participants Requiring an Alternative Intubation Technique(During attempted endotracheal intubation after study drug administration, assessed within approximately 10 minutes after induction of anesthesia)
- Percentage of Participants With Movement During Intubation(Within 5 minutes after the study drug administration)
- Percentage of Participants Requiring Adjunct Medication to Facilitate Induction or Intubation(From induction of anesthesia through successful endotracheal intubation, assessed within approximately 10 minutes after induction of anesthesia)
- Change in Mean Arterial Pressure(From baseline before induction of anesthesia through successful endotracheal intubation, assessed within approximately 10 minutes after induction of anesthesia)
- Change in Heart Rate(From baseline before induction of anesthesia through successful endotracheal intubation, assessed within approximately 10 minutes after induction of anesthesia)
- Percentage of Participants With Hypotension, Bradycardia, or Oxygen Desaturation During Induction and Intubation(From induction of anesthesia through successful endotracheal intubation, assessed within approximately 10 minutes after induction of anesthesia)
- Percentage of Participants With Intubation-Related Complications(During endotracheal intubation after study drug administration, assessed within approximately 10 minutes after induction of anesthesia)
- Time From Successful Endotracheal Intubation to Acquisition of Baseline Motor Evoked Potentials(From successful endotracheal intubation until acquisition of baseline motor evoked potentials before patient positioning)
- Motor Evoked Potential Signal Quality(At baseline neuromonitoring assessment after successful endotracheal intubation and before patient positioning)
- Percentage of Participants With Postoperative Myalgia at 24 Hours(24 hours after surgery)
- Percentage of Participants With Postoperative Myalgia at 48 Hours(48 hours after surgery)
- Postoperative Opioid Consumption(From completion of surgery through 48 hours after surgery)
研究者
Shaun Gruenbaum
Principal Investigator
Mayo Clinic