Effect of Reversal of Neuromuscular Blockade on the Amplitude of Motor Evoked Potentials: A Randomized Controlled Crossover Study Comparing Sugammadex and Placebo
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes Motor Evoked Potentials (MEPs) Amplitude at 3 Minutes
研究概览
简要总结
Intraoperative monitoring of the motor evoked potentials has been shown to be both a sensitive and specific indicator for detecting intraoperative neurological injuries during spine surgery.(Fehlings, Brodke et al. 2010) It is utilized whenever there is risk for injury of nerve roots or the spinal cord during the procedure.
Anesthetic agents, especially the inhaled volatile anesthetics and muscle relaxants, are con-founders for motor evoked potential monitoring as they have deleterious effects on the amplitude of motor evoked potentials.(Sekimoto, Nishikawa et al. 2006) Hence, total intravenous anesthesia with no intraoperative muscle relaxants, are the standard anesthetic technique for these surgeries.
Muscle relaxants are usually required during the induction of anesthesia and endotracheal intubation of larynx. Current practice is to wait for the resolution of residual neuromuscular blockade before the motor evoked potential recordings (MEP) are initiated and this makes it difficult to assess if there was any neurological injury associated with positioning of the patient. A previous case series has shown that reversal of muscle relaxant can improve the amplitude of MEPs.(Batistaki, Papadopoulos et al. 2012) The aim of this study is to perform a randomized controlled trial to study the changes in motor evoked potential amplitudes comparing sugammadex and placebo.
详细描述
Motor evoked potential monitoring is a well-established and safe intervention to assist in prevention of intraoperative injury during spine surgery.(Schwartz, Sestokas et al. 2011) Patients with cervical myelopathy often present with neurological deficits and recording of the motor evoked potentials are often challenging in these patients. In addition, anesthetic agents especially muscle relaxants can abolish the motor response making it difficult to know when the baseline MEP can be recorded.
The usual anesthetic practice for patients undergoing posterior cervical spine surgery is to administer muscle relaxation to aid intubation at the start of the case . The neuromuscular blockade is then allowed to wear off and the neurophysiologist will attempt to record their baseline motor evoked potentials during or just prior to surgical exposure.
The issues with this current technique are;
- Patients cannot be monitored for neurological changes during their transfer into the prone position
- There is likely residual neuromuscular blockade decreasing the amplitude of motor evoked potentials.
Investigators plan to perform a randomized controlled cross-over trial comparing the change in MEP amplitudes with administration of sugammadex or placebo. This will be performed on at risk patients (e.g. cervical myelopathy) undergoing posterior cervical spine surgery where MEPs can be more difficult to attain but of higher utility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a randomized blinded study where the administering anesthetist, surgeon and neurophysiologists will be blinded to the intervention.
Further, a blinded research assistant will perform assessment, data collection, and analysis of neurophysiology data attained.
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
- 否
入选标准
- •All adult patients aged 18-80 years with American Society of Anesthesiologist (ASA) classification I-III undergoing cervical spine surgery in the prone position with intraoperative motor evoked potential monitoring.
- •Operation time greater than 3 hours
排除标准
- •Allergy to propofol or documented egg allergy
- •Known allergy to sugammadex
- •Severe renal dysfunction (EGFR<30)
- •British Research Medical Council (BRMC) motor grading <3 in any peripheral muscle group preoperatively. This is inability to move the muscle group against gravity.
- •Surgical requirement of strict muscle relaxation for surgical exposure
- •Lack of informed consent
- •Pregnancy
- •Loss of MEP signals during washout period (or intraoperative spinal cord injury resulting in irreversible loss of MEP)
研究组 & 干预措施
Initial Arm
The study participants will receive either Sugammadex (2 mg/kg in 10 ml 0.9% normal saline) or placebo (10 ml of 0.9% normal saline).
干预措施: Sugammadex Injection [Bridion] (Drug)
Initial Arm
The study participants will receive either Sugammadex (2 mg/kg in 10 ml 0.9% normal saline) or placebo (10 ml of 0.9% normal saline).
干预措施: Placebo (Drug)
Crossover Arm
The study participants will receive the study medication that was not given in the initial arm (either Sugammadex (2 mg/kg in 10 ml 0.9% normal saline) or placebo (10 ml of 0.9% normal saline) .
干预措施: Sugammadex Injection [Bridion] (Drug)
Crossover Arm
The study participants will receive the study medication that was not given in the initial arm (either Sugammadex (2 mg/kg in 10 ml 0.9% normal saline) or placebo (10 ml of 0.9% normal saline) .
干预措施: Placebo (Drug)
结局指标
主要结局
Changes Motor Evoked Potentials (MEPs) Amplitude at 3 Minutes
时间窗: Baseline and 3 minutes after the study intervention
Changes in the amplitude of the Motor Evoked Potentials from the baseline in the first dorsal interosseous muscle at 3 minutes in sugammadex group compared to placebo group
次要结局
- MEPs Amplitude Changes in Both Sugammadex and Placebo Groups(Baseline to 6 minutes)
- Patient Movement(From 0 to 15 minutes)
- MEPs Amplitude Changes From Baseline at 9 Minutes(Baseline to 9 minutes)
- Surgical Grading of Relaxation of the Surgical Field(approximatelt 1 hour - 30 min during surgical exposure and 30 minutes during closure)
研究者
Lashmi Venkatraghavan
Associate Professor, Department of Anesthesia, Toronto Western Hospital, Toronto, Canada
University Health Network, Toronto