Comparison of the Effects of Vecuronium and Cisatracurium on Electrophysiologic Monitoring During Neurosurgery

Recently intraoperative motor evoked potential monitoring (MEP) is widely used to reduce neural damage during neurosurgery.

As neuromuscular blockade(NMB) during MEP monitoring decreases the amplitude of MEP, partial NMB is usually maintained during general anesthesia. Continuous infusion of NMB agent is preferred than bolus infusion during MEP monitoring. There are a lot of NMB agents in clinical use. But there have been no reports about the effect of changing NMB agent on efficacy of MEP monitoring.

Therefore, the investigators performed a randomized controlled trial to evaluate the effect of changing NMB agent on the variability of MEP amplitude during neurosurgery.

Study Overview

• Status: Completed
• Conditions: Brain Tumor; General Anesthesia; Cerebral Aneurysm; Neurosurgery; Spine Tumor; Motor Evoked Potential Monitoring
• Intervention / Treatment: Other: MEP monitoring with continuous infusion of cisatracurium during general anesthesia; Other: MEP monitoring with continuous infusion of vecuronium during general anesthesia

Detailed Description

Recently intraoperative motor evoked potential monitoring (MEP) is widely used to reduce neural damage during neurosurgery.

As neuromuscular blockade(NMB) during MEP monitoring decreases the amplitude of MEP, partial NMB is usually maintained during general anesthesia. Continuous infusion of NMB agent is preferred than bolus infusion during MEP monitoring. There are a lot of NMB agents in clinical use. But there have been no reports about the effect of changing NMB agent on efficacy of MEP monitoring.

Therefore, the investigators performed a randomized controlled trial to evaluate the effect of changing NMB agent on the variability of MEP amplitude during neurosurgery.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cisatracurium Group; MEP monitoring with continuous infusion of cisatracurium during general anesthesia	Other: MEP monitoring with continuous infusion of cisatracurium during general anesthesia; MEP monitoring with continuous infusion of cisatracurium during general anesthesia
Active Comparator: Vecuronium Group; MEP monitoring with continuous infusion of vecuronium during general anesthesia	Other: MEP monitoring with continuous infusion of vecuronium during general anesthesia; MEP monitoring with continuous infusion of vecuronium during general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MEP amplitude	intraoperative motor evoked potential monitoring amplitude	15 min after anesthetic induction
MEP amplitude	intraoperative motor evoked potential monitoring amplitude	30 min after anesthetic induction
MEP amplitude	intraoperative motor evoked potential monitoring amplitude	45 min after anesthetic induction
MEP amplitude	intraoperative motor evoked potential monitoring amplitude	60 min after anesthetic induction
MEP amplitude	intraoperative motor evoked potential monitoring amplitude	75 min after anesthetic induction
MEP amplitude	intraoperative motor evoked potential monitoring amplitude	90 min after anesthetic induction
MEP amplitude	intraoperative motor evoked potential monitoring amplitude	105 min after anesthetic induction
MEP amplitude	intraoperative motor evoked potential monitoring amplitude	120 min after anesthetic induction
MEP amplitude	intraoperative motor evoked potential monitoring amplitude	135 min after anesthetic induction
MEP amplitude	intraoperative motor evoked potential monitoring amplitude	150 min after anesthetic induction
MEP amplitude	intraoperative motor evoked potential monitoring amplitude	165 min after anesthetic induction
MEP amplitude	intraoperative motor evoked potential monitoring amplitude	180 min after anesthetic induction
MEP amplitude	intraoperative motor evoked potential monitoring amplitude	195 min after anesthetic induction
MEP amplitude	intraoperative motor evoked potential monitoring amplitude	210 min after anesthetic induction
MEP amplitude	intraoperative motor evoked potential monitoring amplitude	225 min after anesthetic induction
MEP amplitude	intraoperative motor evoked potential monitoring amplitude	240 min after anesthetic induction
MEP amplitude	intraoperative motor evoked potential monitoring amplitude	255 min after anesthetic induction
MEP amplitude	intraoperative motor evoked potential monitoring amplitude	270 min after anesthetic induction
MEP amplitude	intraoperative motor evoked potential monitoring amplitude	285 min after anesthetic induction
MEP amplitude	intraoperative motor evoked potential monitoring amplitude	300 min after anesthetic induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coefficient of variation (CV) of MEP amplitude	Coefficient of variation (CV) of intraoperative motor evoked potential monitoring amplitude	at the end of the surgery (5H after the start of surgery)
Average of MEP amplitudes	Average of all measured MEP amplitudes in a subject	at the end of the surgery (5H after the start of surgery)
The frequency of adjusting the infusion dose of muscle relaxant	The frequency of adjusting the infusion dose of muscle relaxant	at the end of the surgery (5H after the start of surgery)
Average of Latency of MEP amplitude	Average of Latency of MEP amplitude	at the end of the surgery (5H after the start of surgery)

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: September 10, 2012
• First Submitted That Met QC Criteria: September 18, 2012
• First Posted (Estimate): September 21, 2012

Study Record Updates

• Last Update Posted (Estimate): December 25, 2013
• Last Update Submitted That Met QC Criteria: December 24, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Neurosurgery; Cisatracurium; General Anesthesia; Motor evoked potential monitoring; Vecuronium
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Neuromuscular Agents; Nicotinic Antagonists; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Anesthetics; Cisatracurium; Vecuronium Bromide
• Other Study ID Numbers: 2012-05-090-001