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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeong Jin Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01690364
First received: September 10, 2012
Last updated: December 24, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Motor Evoked Potential Monitoring
General Anesthesia
Neurosurgery
Brain Tumor
Spine Tumor
Cerebral Aneurysm
Other: MEP monitoring with continuous infusion of vecuronium during general anesthesia
Other: MEP monitoring with continuous infusion of cisatracurium during general anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: Comparison of the Effects of Vecuronium and Cisatracurium on Electrophysiologic Monitoring During Neurosurgery

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • MEP amplitude [ Time Frame: 15 min after anesthetic induction ] [ Designated as safety issue: No ]
    intraoperative motor evoked potential monitoring amplitude

  • MEP amplitude [ Time Frame: 30 min after anesthetic induction ] [ Designated as safety issue: No ]
    intraoperative motor evoked potential monitoring amplitude

  • MEP amplitude [ Time Frame: 45 min after anesthetic induction ] [ Designated as safety issue: No ]
    intraoperative motor evoked potential monitoring amplitude

  • MEP amplitude [ Time Frame: 60 min after anesthetic induction ] [ Designated as safety issue: No ]
    intraoperative motor evoked potential monitoring amplitude

  • MEP amplitude [ Time Frame: 75 min after anesthetic induction ] [ Designated as safety issue: No ]
    intraoperative motor evoked potential monitoring amplitude

  • MEP amplitude [ Time Frame: 90 min after anesthetic induction ] [ Designated as safety issue: No ]
    intraoperative motor evoked potential monitoring amplitude

  • MEP amplitude [ Time Frame: 105 min after anesthetic induction ] [ Designated as safety issue: No ]
    intraoperative motor evoked potential monitoring amplitude

  • MEP amplitude [ Time Frame: 120 min after anesthetic induction ] [ Designated as safety issue: No ]
    intraoperative motor evoked potential monitoring amplitude

  • MEP amplitude [ Time Frame: 135 min after anesthetic induction ] [ Designated as safety issue: No ]
    intraoperative motor evoked potential monitoring amplitude

  • MEP amplitude [ Time Frame: 150 min after anesthetic induction ] [ Designated as safety issue: No ]
    intraoperative motor evoked potential monitoring amplitude

  • MEP amplitude [ Time Frame: 165 min after anesthetic induction ] [ Designated as safety issue: No ]
    intraoperative motor evoked potential monitoring amplitude

  • MEP amplitude [ Time Frame: 180 min after anesthetic induction ] [ Designated as safety issue: No ]
    intraoperative motor evoked potential monitoring amplitude

  • MEP amplitude [ Time Frame: 195 min after anesthetic induction ] [ Designated as safety issue: No ]
    intraoperative motor evoked potential monitoring amplitude

  • MEP amplitude [ Time Frame: 210 min after anesthetic induction ] [ Designated as safety issue: No ]
    intraoperative motor evoked potential monitoring amplitude

  • MEP amplitude [ Time Frame: 225 min after anesthetic induction ] [ Designated as safety issue: No ]
    intraoperative motor evoked potential monitoring amplitude

  • MEP amplitude [ Time Frame: 240 min after anesthetic induction ] [ Designated as safety issue: No ]
    intraoperative motor evoked potential monitoring amplitude

  • MEP amplitude [ Time Frame: 255 min after anesthetic induction ] [ Designated as safety issue: No ]
    intraoperative motor evoked potential monitoring amplitude

  • MEP amplitude [ Time Frame: 270 min after anesthetic induction ] [ Designated as safety issue: No ]
    intraoperative motor evoked potential monitoring amplitude

  • MEP amplitude [ Time Frame: 285 min after anesthetic induction ] [ Designated as safety issue: No ]
    intraoperative motor evoked potential monitoring amplitude

  • MEP amplitude [ Time Frame: 300 min after anesthetic induction ] [ Designated as safety issue: No ]
    intraoperative motor evoked potential monitoring amplitude


Secondary Outcome Measures:
  • Coefficient of variation (CV) of MEP amplitude [ Time Frame: at the end of the surgery (5H after the start of surgery) ] [ Designated as safety issue: No ]
    Coefficient of variation (CV) of intraoperative motor evoked potential monitoring amplitude

  • Average of MEP amplitudes [ Time Frame: at the end of the surgery (5H after the start of surgery) ] [ Designated as safety issue: No ]
    Average of all measured MEP amplitudes in a subject

  • The frequency of adjusting the infusion dose of muscle relaxant [ Time Frame: at the end of the surgery (5H after the start of surgery) ] [ Designated as safety issue: No ]
    The frequency of adjusting the infusion dose of muscle relaxant

  • Average of Latency of MEP amplitude [ Time Frame: at the end of the surgery (5H after the start of surgery) ] [ Designated as safety issue: No ]
    Average of Latency of MEP amplitude


Enrollment: 74
Study Start Date: July 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: 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
Other Name: 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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690364

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

Responsible Party: Jeong Jin Lee, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01690364     History of Changes
Other Study ID Numbers: 2012-05-090-001
Study First Received: September 10, 2012
Last Updated: December 24, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Motor evoked potential monitoring
General Anesthesia
Neurosurgery
Cisatracurium
Vecuronium

Additional relevant MeSH terms:
Aneurysm
Brain Neoplasms
Intracranial Aneurysm
Brain Diseases
Vascular Diseases
Cardiovascular Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Anesthetics
Vecuronium Bromide
Atracurium
Cisatracurium
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on July 26, 2014