Neurophysiological Monitoring and Videolaryngoscopy

Not Applicable

• Conditions: Postsynaptic Potential Summation
• Interventions: Procedure: Neurophysiological monitoring during intubation

• Registration Number: NCT04576637
• Lead Sponsor: Rabin Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-09-29
• Study First Posted: 2020-10-06
• Study Start: 2020-10-21
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-01
• Last Update Posted: 2022-05-03
• Primary Completion: 2022-12-21
• Study Completion: 2023-02-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neurophysiological monitoring during induction	Neurophysiological monitoring during intubation	-

Primary Outcome Measures

Name	Time	Method
Differences is somatosensory evoked potentials and motor evoked potentials signals during intubation	During surgery

Trial Locations

Locations (1)

Rabin Medical Center/Beilinson Campus; 🇮🇱 Petach Tikva, Israel