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

NCT04997707 | Completed Phase 4 DMC

• 1 other identifier: 322018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

motor-evoked potentials, sevoflurane, balanced anesthesia,

Outcome Measures

Primary Outcomes (3)

• TcMEP Monitoring (R1)

  The first TcMEP (R1) was taken before positioning and surgical incision, at least 20-25 min

  " up to 45 minutes"

• TcMEP Monitoring(R2)

  R2), after positioning of the patient

  "up to 60 minutes"

• TcMEP Monitoring(R3)

  (R3) was taken after the surgical incision

  " up to 75 minutes"

Secondary Outcomes (13)

• Mean arterial blood pressure (MAP)

  " up to 5 hours"

• pulse rate

  " up to 5 hours"

• Spo2

  " up to 5 hours"

• temperature

  " up to 5 hours"

• propofol infusion rate

  " up to 5 hours"

Study Arms (2)

P group

ACTIVE COMPARATOR

75-100 µg/kg/min propofol

Drug: Propofol Abbott; Diagnostic Test: transcranial motor evoked potential(Tcm

BA group

ACTIVE COMPARATOR

25ug/kg/min propofol and 0.2% below corrected-to-age- half MAC of sevoflurane

Drug: Propofol Abbott; Drug: Sevoflurane Inhalation Solution; Diagnostic Test: transcranial motor evoked potential(Tcm

Interventions

Propofol Abbott DRUG

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

Also known as: propofol

BA group; P group

Sevoflurane Inhalation Solution DRUG

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.

Also known as: sevoflurane

BA group

transcranial motor evoked potential(Tcm DIAGNOSTIC_TEST

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.

Also known as: intraoperative neurophysiological monitoring (IONM)

BA group; P group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: More than 18 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (ASA) grades I-II who were scheduled for spinal surgeries (intraspinal tumors resection, spondylolisthesis correction, traumatic spinal fractures fixation….etc)

You may not qualify if:

• Patients aged less than 18 years, or with history of drug abuse, any pulmonary disease, preoperative motor deficit, history of epilepsy, pacemakers and cochlear implants, previous intracranial surgeries or needed to deepen anesthetic plane during surgery

Sponsors & Collaborators

• El-Sahel Teaching Hospital: lead

Study Sites (2)

National cancer Institute

Cairo, 000000, Egypt

Location

El sahel Teaching Hospital

Cairo, 767565, Egypt

Location

MeSH Terms

Interventions

Propofol; Sevoflurane; Intraoperative Neurophysiological Monitoring

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Monitoring, Intraoperative; Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Neurophysiological Monitoring; Surgical Procedures, Operative

Study Officials

• Samir A El kafrawy, MD

  El-Sahel Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: consultant of anesthesia, head of neuroanesthesia unit

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 10, 2021
• Study Start: April 6, 2017
• Primary Completion: March 5, 2020
• Study Completion: April 5, 2021
• Last Updated: August 10, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)