NCT01690364

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

December 25, 2013

Status Verified

December 1, 2013

Enrollment Period

8 months

First QC Date

September 10, 2012

Last Update Submit

December 24, 2013

Conditions

Motor Evoked Potential MonitoringGeneral AnesthesiaNeurosurgeryBrain TumorSpine TumorCerebral Aneurysm

Keywords

Motor evoked potential monitoringGeneral AnesthesiaNeurosurgeryCisatracuriumVecuronium

Outcome Measures

Primary Outcomes (20)

  • 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 Outcomes (4)

  • Coefficient of variation (CV) of MEP amplitude

    at the end of the surgery (5H after the start of surgery)

  • Average of MEP amplitudes

    at the end of the surgery (5H after the start of surgery)

  • 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

    at the end of the surgery (5H after the start of surgery)

Study Arms (2)

Cisatracurium Group

EXPERIMENTAL

MEP monitoring with continuous infusion of cisatracurium during general anesthesia

Other: MEP monitoring with continuous infusion of cisatracurium during general anesthesia

Vecuronium Group

ACTIVE COMPARATOR

MEP monitoring with continuous infusion of vecuronium during general anesthesia

Other: MEP monitoring with continuous infusion of vecuronium during general anesthesia

Interventions

MEP monitoring with continuous infusion of vecuronium during general anesthesiaOTHER

MEP monitoring with continuous infusion of vecuronium during general anesthesia

Vecuronium Group
MEP monitoring with continuous infusion of cisatracurium during general anesthesiaOTHER

MEP monitoring with continuous infusion of cisatracurium during general anesthesia

Cisatracurium Group

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients undergoing neurosurgery with intraoperative motor evoked potential monitoring

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Brain NeoplasmsIntracranial Aneurysm

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesIntracranial Arterial DiseasesCerebrovascular DisordersAneurysmVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 10, 2012

First Posted

September 21, 2012

Study Start

July 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

December 25, 2013

Record last verified: 2013-12

Locations

KR(1)