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Neurophysiological Monitoring and Videolaryngoscopy

Neurophysiological Monitoring During Videolaryngoscopy and Tracheal Intubation in Patient With Unstable Cervical Spine: A Prospective, Interventional, Cohort Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04576637
Enrollment
20
Registered
2020-10-06
Start date
2020-10-21
Completion date
2023-02-21
Last updated
2022-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postsynaptic Potential Summation

Brief summary

Myopathic patients undergoing cervical spine surgery are at risk for postoperative neurological deficits and sequelae. Awake fiberoptic intubation is considered the technique of choice for tracheal intubation in patient with cervical spine instability. However, awake fiberoptic intubation frequently causes significant patient discomfort, requires patient cooperation, anesthesiologist expertise and the availability of costly equipment . Videolaryngoscopy guided intubation is considered to be an effective alternative to awake fiberoptic intubation for cervical spine surgeries. Intraoperative neurophysiological monitoring (IONM) is a method that provides real time evaluation of the functional integrity of neural structures. The goal of IONM is to make surgery safer by detecting incipient neurological insults at a time when it can be avoided or minimized and by aiding in the identification of neural structure Rayia, et al. have described a case of monitoring intubation and neck extension for the indication of thyroidectomy in a Down syndrome boy with atlantoaxial instability under anesthesia with propofol and remifentanil without neuromuscular blockade. The authors conclude that this approach can be used to protect against spinal cord compression. While research has thoroughly evaluated the effect of laryngoscopy and intubation on cervical spine movement, to date, little is known about the impact of intubation process on neurophysiological responses, and on the feasibility of utilizing IONM for establishing a safe airway intubation. This prospective, interventional, cohort study is the first, to our knowledge, to examine the feasibility and added benefits of IONM throughout anesthetic intubation in patients undergoing cervical spine surgeries with the use of videolarynscope guided intubation.

Interventions

PROCEDURENeurophysiological monitoring during intubation

In the operating room patients will be connected to the anesthesia monitor and an IV line as standard clinical practice. Participants will receive oxygen and an IV infusion of 1-3 ng/ml remifentanil via TCI infusion pump to achieve mild sedation. Patients will then be connected to the neurophysiological electrodes to monitor for EEG, EMG, SSEP and MEP signals. After preparing the videolaryngoscope, anesthesia induction will be achieved with the use of IV ketamine 2mg/kg. Then the anesthesiologist will perform a clinical and ECG reading assessment to ensure that the patient is anesthetized and will be able to titrate more ketamine as needed to achieve hypnosis. A biteblock will be located to prevent teeth damage. A neurophysiological baseline recordings will then be performed by a neurophysiologist. The videolaryngoscope will then be inserted, during which a second neurophysiological testing will be performed to ensure the patients safety. Then mechanical ventilation will be initiated.

Sponsors

Rabin Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All patients above 18y old, presenting for cervical spine surgeries , suffering from cervical spine instability, whom are able to comply with the study requirements and gave a written informed consent will be eligible for study enrollment.

Exclusion criteria

* Patients presenting with heart disease will not be eligible to participate. * Patients with anticipated difficult airway. * Patients with a language barrier. * Patients with known allergy to any of the drugs used. * Pregnant women * Patients with a history of seizures or CVA.

Design outcomes

Primary

MeasureTime frame
Differences is somatosensory evoked potentials and motor evoked potentials signals during intubationDuring surgery

Countries

Israel

Contacts

Primary ContactLeonid Eidelman
leidelman@clalit.org.il97239376850
Backup ContactAtara Davis
ataratdavis@gmail.com972533321329

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026