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

Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690364
• Other study ID #: 2012-05-090-001
• Status: Completed
• Phase: N/A
• First received: September 10, 2012
• Last updated: December 24, 2013
• Start date: July 2012
• Est. completion date: March 2013

Study information

• Verified date: December 2013
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Brain Tumor
• Cerebral Aneurysm
• General Anesthesia
• Intracranial Aneurysm
• Motor Evoked Potential Monitoring
• Neurosurgery
• Spine Tumor

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MEP amplitude	intraoperative motor evoked potential monitoring amplitude	15 min after anesthetic induction	No
Primary	MEP amplitude	intraoperative motor evoked potential monitoring amplitude	30 min after anesthetic induction	No
Primary	MEP amplitude	intraoperative motor evoked potential monitoring amplitude	45 min after anesthetic induction	No
Primary	MEP amplitude	intraoperative motor evoked potential monitoring amplitude	60 min after anesthetic induction	No
Primary	MEP amplitude	intraoperative motor evoked potential monitoring amplitude	75 min after anesthetic induction	No
Primary	MEP amplitude	intraoperative motor evoked potential monitoring amplitude	90 min after anesthetic induction	No
Primary	MEP amplitude	intraoperative motor evoked potential monitoring amplitude	105 min after anesthetic induction	No
Primary	MEP amplitude	intraoperative motor evoked potential monitoring amplitude	120 min after anesthetic induction	No
Primary	MEP amplitude	intraoperative motor evoked potential monitoring amplitude	135 min after anesthetic induction	No
Primary	MEP amplitude	intraoperative motor evoked potential monitoring amplitude	150 min after anesthetic induction	No
Primary	MEP amplitude	intraoperative motor evoked potential monitoring amplitude	165 min after anesthetic induction	No
Primary	MEP amplitude	intraoperative motor evoked potential monitoring amplitude	180 min after anesthetic induction	No
Primary	MEP amplitude	intraoperative motor evoked potential monitoring amplitude	195 min after anesthetic induction	No
Primary	MEP amplitude	intraoperative motor evoked potential monitoring amplitude	210 min after anesthetic induction	No
Primary	MEP amplitude	intraoperative motor evoked potential monitoring amplitude	225 min after anesthetic induction	No
Primary	MEP amplitude	intraoperative motor evoked potential monitoring amplitude	240 min after anesthetic induction	No
Primary	MEP amplitude	intraoperative motor evoked potential monitoring amplitude	255 min after anesthetic induction	No
Primary	MEP amplitude	intraoperative motor evoked potential monitoring amplitude	270 min after anesthetic induction	No
Primary	MEP amplitude	intraoperative motor evoked potential monitoring amplitude	285 min after anesthetic induction	No
Primary	MEP amplitude	intraoperative motor evoked potential monitoring amplitude	300 min after anesthetic induction	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Average of Latency of MEP amplitude	Average of Latency of MEP amplitude	at the end of the surgery (5H after the start of surgery)	No