Strategy for Maintaining Partial Neuromuscular Blocking Adequate for Motor Evoked Potential During Neurosurgery

Not Applicable

Completed

• Conditions: Brain Surgery With Motor Evoked Potential Monitoring; Spine Surgery With Motor Evoked Potential Monitoring
• Interventions: Other: TOF count guided adjustment; Other: T1/ T0 guided adjustment; Other: T2/ T0 guided adjustment

• Registration Number: NCT01388868
• Lead Sponsor: Samsung Medical Center

Brief Summary

The maintenance of partial neuromuscular blocking during general anesthesia for neurosurgery is essential for intraoperative motor-evoked potential monitoring. However, the precise strategy of administering neuromuscular blocking agent for obtaining that goal has not been established. Therefore, the investigators tried to find the optimal initial dose of vecuronium infusion and determine the adequate goal of neuromuscular blocking as guided by neuromuscular transmission module (M-NMT Module, Datex-Ohmeda Inc, Helsinki, Finland).

Detailed Description

The maintenance of partial neuromuscular blocking during general anesthesia for neurosurgery is essential for intraoperative motor-evoked potential monitoring. However, the precise strategy of administering neuromuscular blocking agent for obtaining that goal has not been established. Therefore, the investigators tried to find the optimal initial dose of vecuronium infusion and determine the adequate goal of neuromuscular blocking as guided by neuromuscular transmission module (M-NMT Module, Datex-Ohmeda Inc, Helsinki, Finland). Previously, one to two counts of response to TOF stimulation has been considered to be primary goal of partial neuromuscular blocking needed for intraoperative motor evoked potential monitoring. However, the visualization of twitch height of response to TOF stimulation has been possible with the help of NMT module. For adequate motor evoked potential monitoring, twitch height of T1 or T2 is also as important as simple count of TOF stimulation. The investigators tried to establish a vecuronium infusion strategy as guided by not only count of TOF stimulation but also twitch height of T1 or T2.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-07-05
• Study First Posted: 2011-07-07
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-11
• Last Update Posted: 2012-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Adult Patients undergoing neurosurgery with intraoperative motor evoked potential monitoring

Exclusion Criteria

• Patients who can not undergo motor evoked potential monitoring due to central or peripheral neuromuscular disease (e.g. Cerebral palsy, Myasthenia gravis, Acute spinal injury, neurologic shock)
• Patients with hepatic or renal disease with altered metabolism of vecuronium
• Patients with medication which influence the metabolism of vecuronium (e.g. calcium channel blocker, aminoglycoside antibiotics, Lithium, MgSO4)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TOF count guided group	TOF count guided adjustment	adjustment of neuromuscular blocking agent infusion dose every 15 minute as guided by No. of response to TOF stimulation
T1/T0 guided group	T1/ T0 guided adjustment	adjustment of neuromuscular blocking agent infusion dose every 15 minute as guided by T1 twitch height as compared with control (T0)
T2/ T0 guided group	T2/ T0 guided adjustment	adjustment of neuromuscular blocking agent infusion dose every 15 minute as guided by T2 twitch height as compared with baseline (T0)

Primary Outcome Measures

Name	Time	Method
Amplitude of MEP monitoring	every 30 min during MEP monitoring	the value of MEP amplitude every 30 min during MEP monitoring

Secondary Outcome Measures

Name	Time	Method
latency of MEP monitoring	every 30 min during MEP monitoring	latency of MEP monitoring every 30 min during MEP monitoring
Incidence of patient's spontaneous movement	from start to end of the MEP monitoring, an expected average of 4 hours	Incidence of patient's spontaneous movement during MEP monitoring
Overall assessment of MEP monitoring quality	from start to end of the MEP monitoring, an expected average of 4 hours	overall assessment of MEP monitoing quality provided by the electrophysiologist Grade I : no problem all through the monitoring Grade II : difficulty of monitoring for less than 5 min Grade III : difficulty of monitoring for 5 min to 30 min Grade IV : Difficulty of monitoring for more than 30 min
Incidence of patient's spontaneous respiration	from start to end of the MEP monitoring, an expected average of 4 hours	Incidence of patient's spontaneous respiration as determined by end-tidal CO2 curve monitoring

Trial Locations

Locations (1)

Jeong Jin Lee; 🇰🇷 Seoul, Korea, Republic of