Clinical trial NCT05992090: Neuromuscular Blockade Monitoring Using Kine-myography vs Electromyography.
Official title: Neuromuscular Blockade Monitoring Using Kine-myography vs Electromyography in Patients Undergoing General Anaesthesia With the Use of Rocuronium and Cis-atracurium.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Blockade
Residual Neuromuscular Blockade
Keywords: neuromuscular blockade
electromyography
kine-myography
general anaesthesia
rocuronium
cis-atracurium
residual neuromuscular blockade
sugammadex
Lead sponsor: Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 129
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurement variability
timeFrame: From sensor calibration til extubation at TOF higher than 90%.Maximum length of measurement is 6 hours.
Secondary outcomes:
measure: supramaximal electric stimulus
timeFrame: From sensor calibration til extubation at TOF higher than 90%.Maximum length of measurement is 6 hours.
measure: TOF overestimation
timeFrame: From sensor calibration til extubation at TOF higher than 90%.Maximum length of measurement is 6 hours.
Other outcomes:
Locations:
city: Ústí Nad Labem
country: Czechia
facility: Masarykova Nemocnice v Ústí nad Labem, Krajská Zdravotní a.s.
state: Ústí Nad Labem Region
Study officials:
affiliation: Krajská Zdravotní a.s., Masarykova Nemocnice v Ústí nad Labem, Klinika anesteziologie, perioperační a intenzivní medicíny FZS UJEP a MNUL
name: Michal Kalina, MUDr.
role: PRINCIPAL_INVESTIGATOR
References: