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The Effect of Balanced Anesthesia Regimen on Intraoperative Trans-cranial Motor Evoked Potential During Spine Surgeries:

NCT04997707 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-08-10

No results posted yet for this study

Summary

transcranial motor evoked potentials (TcMEP) were proved to be useful during complicated spinal surgeries to prevent iatrogenic complications. The effect of anesthetic agents was comprehensively discussed in literature. The Investigators studied a new balanced anesthetic protocol using propofol and sevoflurane in addition to continuous fentanyl infusion in which they compared values and ratios of amplitudes and latencies of TcMEP waves at different time point.

Conditions

  • Motor Evoked Potential

Interventions

DRUG

Propofol Abbott

in a rate of 75-100 μg/kg/min in P group, and 25μg/kg/min in BA group

DRUG

Sevoflurane Inhalation Solution

in BA group will be calculated by age-adjusted end - tidal MAC as follows: for age of 18-25 years, 26-40 years and ≥40 years MAC will be 2.6%, 2.2% and 1.8% respectively then final concentration to be delivered will be 0.2% lower than calculated half MAC.

DIAGNOSTIC_TEST

transcranial motor evoked potential(Tcm

using NIM-SPINE™ SYSTEM (2005 Medtronic Sofamor Danek USA, Inc.). The stimulation used is a train-of-five square wave stimulation, 2ms inter-stimulus interval, 500 μs width and 40-220 mA intensity which can be increased with 10 mA steps till muscle answer potential is recorded.

Sponsors & Collaborators

  • El-Sahel Teaching Hospital

    lead OTHER_GOV

Principal Investigators

  • Samir A El kafrawy, MD · El-Sahel Teaching Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-06
Primary Completion
2020-03-05
Completion
2021-04-05

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04997707 on ClinicalTrials.gov