Completed

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

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What is being tested

MEP monitoring with continuous infusion of cisatracurium during general anesthesia

+ MEP monitoring with continuous infusion of vecuronium during general anesthesia

Other
Who is being recruted

Aneurysm+11

+ Brain Diseases

+ Cardiovascular Diseases

From 20 to 75 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Interventional
Study Start: July 2012
See protocol details

Summary

Principal SponsorSamsung Medical Center
Last updated: December 25, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01690364
Principal SponsorSamsung Medical Center
Last updated: December 25, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

74 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AneurysmBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersNeoplasmsNeoplasms by SiteNervous System DiseasesNervous System NeoplasmsVascular DiseasesCentral Nervous System NeoplasmsIntracranial Arterial DiseasesBrain NeoplasmsIntracranial Aneurysm

Criteria

1 inclusion criteria required to participate
Adult patients undergoing neurosurgery with intraoperative motor evoked potential monitoring
3 exclusion criteria prevent from participating
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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
MEP monitoring with continuous infusion of cisatracurium during general anesthesia

Group II

Active Comparator
MEP monitoring with continuous infusion of vecuronium during general anesthesia

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Samsung Medical Center

Seoul, South KoreaOpen Samsung Medical Center in Google Maps
CompletedOne Study Center