Neuromuscular Blockade Monitoring Using Kine-myography vs Electromyography.

NCT05992090 | Completed

• 1 other identifier: EMG vs KMG
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare two monitoring methods of neuromuscular blockade - Kine-myography and Electromyography. The main questions to answer are:

• are electromyography and kine-myography interchangeable
• is electromyography linked to fewer fault results
• is electromyography using lower energy to stimulate nerves The type of study is a multicentric observational clinical trial. Subjects are patients undergoing general anaesthesia with the use of rocuronium or cis-atracurium. In each patient, the neuromuscular blockade will be monitored using kine-myograph and electromyography simultaneously.

Conditions

Neuromuscular Blockade; Residual Neuromuscular Blockade

Keywords

neuromuscular blockade; electromyography; kine-myography; general anaesthesia; rocuronium; cis-atracurium; residual neuromuscular blockade; sugammadex

Outcome Measures

Primary Outcomes (1)

• Measurement variability

  A primary aim is to demonstrate that measurement of the depth of neuromuscular blockade using kinemyography is associated with a higher measurement variability than measurement of the depth of neuromuscular blockade using electromyography.

  From sensor calibration til extubation at TOF higher than 90%.Maximum length of measurement is 6 hours.

Secondary Outcomes (2)

• supramaximal electric stimulus

  From sensor calibration til extubation at TOF higher than 90%.Maximum length of measurement is 6 hours.

• TOF overestimation

  From sensor calibration til extubation at TOF higher than 90%.Maximum length of measurement is 6 hours.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be selected from residents of the Northern Bohemia region. All included patients will be indicated for surgery in general anesthesia with the need for neuromuscular blockade. All selected patients will be hospitalized at Masaryk Hospital in Ústí nad Labem.

You may qualify if:

• patients undergoing surgery under general anaesthesia with the use of cis-atracurium or rocuronium

You may not qualify if:

• patients suffering from neuromuscular diseases
• patients with known allergy to rocuronium or cis-atracurium
• patients in whom it is impossible to measure the depth of the neuromuscular block on the upper extremities (injuries of the upper extremities, contractures etc.)
• patients undergoing surgery positioned on their side
• patients with an upper arm injury
• patients with acromegaly
• patients with Alzheimer's disease
• patients with the risk of difficult airways
• patients induced into general anaesthesia via the Rapid Sequence Induction method
• patients with a weight under 5 kilograms

Sponsors & Collaborators

• Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.: lead

Study Sites (1)

Masarykova Nemocnice v Ústí nad Labem, Krajská Zdravotní a.s.

Ústí nad Labem, Ústí Nad Labem Region, 40001, Czechia

Location

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michal Kalina, MUDr.

  Krajská Zdravotní a.s., Masarykova Nemocnice v Ústí nad Labem, Klinika anesteziologie, perioperační a intenzivní medicíny FZS UJEP a MNUL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 15, 2023
• Study Start: October 10, 2023
• Primary Completion: May 29, 2024
• Study Completion: May 29, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

CZ (1)