Comparison of the Effects of Vecuronium and Cisatracurium on Electrophysiologic Monitoring During Neurosurgery
This study is currently recruiting participants.
Verified September 2012 by Samsung Medical Center
Sponsor:
Samsung Medical Center
Information provided by (Responsible Party):
Jeong Jin Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01690364
First received: September 10, 2012
Last updated: September 21, 2012
Last verified: September 2012
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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
| Estimated Enrollment: | 80 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01690364
Contacts
| Contact: Jeong Jin Lee, MD, PhD | +82-2-3410-2467 | jjeong.lee@samsung.com |
| Contact: Won Ho Kim, MD | +82-2-3410-2470 | bullet57@naver.com |
Locations
| Korea, Republic of | |
| Samsung Medical Center | Recruiting |
| Seoul, Korea, Republic of, 135-710 | |
| Contact: Yang Hoon Chung, MD +82-2-3410-2470 yh79.chung@samsung.com | |
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: | September 21, 2012 |
| 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:
|
Brain Neoplasms Spinal Cord Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Spinal Cord Diseases Aneurysm Intracranial Aneurysm Vascular Diseases Cardiovascular Diseases 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 |
ClinicalTrials.gov processed this record on May 16, 2013