Clinical trial NCT04845386: : A Comparison of Neuromuscular Transmission in the Muscles During General Anesthesia
Official title: A Comparison of Neuromuscular Transmission in the Arm and Hand Muscles With Alternative Muscles Such as the Lower Leg Muscles and the Corrugator Supercilii During General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Blockade
Keywords: TOF Cuff
TOF Scan
Neuromuscular transmission
corrugator supercilii
Mivacurium
adductor pollicis
Lead sponsor: University of Warmia and Mazury in Olsztyn
Sponsor class: OTHER
Collaborators: name: Regional Specialized Hospital in Olsztyn
First posted: 2021-04-15
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In the study will take patients qualified to the elective surgery

Brief summary: The investigators want to compare new muscle relaxation monitoring, TOF-Cuff and TOF-Scan, during general anesthesia. Standard monitoring is using thumb, however it can't be use on every patient. Alternative can be eyebrow muscle or foot muscle.

There is only few old study that compares this muscle and used mivacurium. The study aims to compare TOF-Cuff and TOF-Scan with different sensor and use mivacurium.

Detailed description: In our research in addition to the standard intraoperative monitoring, which includes the assessment of ECG and saturation, the investigators would like to estimate muscle relaxation by using two different methods: a TOF-Cuff which additionally allows to measure inoperative blood pressure and TOF-Scan with different sensor. Our aim is to compare two different methods of muscle relaxation monitoring in patients who will administer muscle relaxant - mivacurium. After receiving painkillers and hypnotics, when the patient is falling asleep, the standard dose of mivacurium 0.2 mg / kg body weight will be administered. Then, painless simultaneous stimulation with TOF-Cuff and TOF-Scan devices will begin. Until intubation, measurements will be made in every 30 seconds and then every 5 minutes until extubation. Extubation will take place according to the guidelines when the TOF-Cuff measurement on the arm is greater than 0.9 - this is the value at which the patient is considered ready to start breathing on his own. The following will be documented: the initiation of drug administration, intubation, possible repeated doses of mivacurium 2 mg, antagonization, extubation, possible side effects (e.g., transient cardiac disturbances, reddening of the skin, lowering blood pressure, bronchospasm, erythema, urticaria) and technical problems.

Eligibility criteria: Inclusion Criteria:

* Age 18-75
* ASA classification I,II,III
* Elective surgery
* BMI(body mass index) 17-35
* Surgery in the supine position
* Informed consent of the patient

Exclusion Criteria:

* Pregnancy and breastfeeding
* Urgent indications for surgery
* ASA classification \>III
* Neuromuscular diseases
* Polyneuropathy
* Diabetes
* Drug addiction
* Family history of malignant hyperthermia
* Allergic to propofol, fentanyl or mivacurium

Primary outcomes:
measure: Onset time
timeFrame: 1 to 10 minutes
measure: Total recovery time of neuromuscular block
timeFrame: 30 to 500 minutes
Secondary outcomes:
measure: Time to repeated dose
timeFrame: 5 to 200 minutes
Other outcomes:
Locations:
city: Olsztyn
country: Poland
facility: Anesthesiology and Intensive Care Clinical Ward, Regional Specialized Hospital
state: Warmia-Mazury
Study officials:
References: