Neuromuscular Blockade Monitoring Using Kine-myography vs Electromyography.

Neuromuscular Blockade Monitoring Using Kine-myography vs Electromyography in Patients Undergoing General Anaesthesia With the Use of Rocuronium and Cis-atracurium.

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.

Study Overview

• Status: Recruiting
• Conditions: Neuromuscular Blockade; Residual Neuromuscular Blockade

Detailed Description

Informed consent will first be obtained from the patient for inclusion in the study. Consent will be obtained during an examination by the anaesthesiologist providing anaesthetic care during surgery in the anteroom of the operating theatre.

Once informed consent has been obtained, a routine orientation examination will be performed by the anaesthetist and routine pre-operative preparation (provision of peripheral venous access, risk assessment for airway obstruction, etc.) will be performed. The patient will then be transported to the operating theatre.

In the operating room, patient monitoring will be initiated, including the deployment of sensors to monitor the depth of neuromuscular blockade. The KMG sensor will be placed on the right arm and the EMG sensor on the left arm. After deployment of the sensors, upper limb fixation will be performed by the anaesthetic nurse. The fixation will be performed with splints compatible with the operating table. Fixation of the limbs and sensor with adhesive tape will not be used.

The anaesthesia will then be induced. Propofol and sufentanil will be administered at the discretion of the anaesthetist providing anaesthetic care. Once sufficient depth of sedation has been induced, calibration of the sensors monitoring the depth of neuromuscular blockade will be performed. After calibration of the sensors, the supramaximal current to the CRF will be recorded. The measurement interval will be set to 20 s. After securing the airway, the interval will be extended to 5 - 15 min according to the nature of the surgery and the discretion of the anaesthesiologist providing anaesthetic care. The number of twitches (PCT) and the Train Of Four (TOF) value will be recorded throughout the procedure.

On emergence from anaesthesia, the measurement interval will be set to 1 minute. Once sufficient depth of neuromuscular blockade has been reached to allow extubation, monitoring of the depth of neuromuscular blockade will be discontinued.

If during the measurement of the depth of neuromuscular blockade a value is measured that is highly suspected to be in error, this suspicion will be recorded in the CRF with a justification.

• Study Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: Michal Kalina, MUDr.; Phone Number: +420 +420477112202; Email: michal.kalina@kzcr.eu

Study Locations

• Czechia
  • Ústí Nad Labem Region
    • Ústí Nad Labem, Ústí Nad Labem Region, Czechia, 40001
      • Recruiting
      • Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
      • Contact: Michal Kalina; Phone Number: +420 773628756; Email: michal.kalina@kzcr.eu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
supramaximal electric stimulus	A secondary aim is to demonstrate that measuring the depth of neuromuscular blockade using kinemyography is associated with a higher supramaximal electric stimulus than measuring the depth of neuromuscular blockade using electromyography.	From sensor calibration til extubation at TOF higher than 90%.Maximum length of measurement is 6 hours.
TOF overestimation	The primary objective of the study is to demonstrate that there is measured higher TOF when using KMG to monitor the depth of neuromuscular blockade compared to using EMG sensor to monitor the depth of neuromuscular blockade.	From sensor calibration til extubation at TOF higher than 90%.Maximum length of measurement is 6 hours.

Collaborators and Investigators

• Sponsor: Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
• Investigators: Principal Investigator: Michal Kalina, MUDr., Krajská Zdravotní a.s., Masarykova Nemocnice v Ústí nad Labem, Klinika anesteziologie, perioperační a intenzivní medicíny FZS UJEP a MNUL

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): December 10, 2024

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: general anaesthesia; electromyography; rocuronium; neuromuscular blockade; sugammadex; residual neuromuscular blockade; kine-myography; cis-atracurium
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Delayed Emergence from Anesthesia
• Other Study ID Numbers: EMG vs KMG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No