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: A Comparison of Neuromuscular Transmission in the Muscles During General Anesthesia

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04845386
Enrollment
128
Registered
2021-04-15
Start date
2021-03-25
Completion date
2021-06-30
Last updated
2022-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Blockade

Keywords

TOF Cuff, TOF Scan, Neuromuscular transmission, corrugator supercilii, Mivacurium, adductor pollicis

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.

Interventions

DEVICETOF Cuff on arm

The TOF Cuff will be installed on one arm in opposite of TOF Scan. After intubation dose of mivacurium continuous monitoring of neuromuscular block started until complete recovery of neuromuscular block.

DEVICETOF Cuff on lower leg

The TOF Cuff will be installed on one lower leg. After intubation dose of mivacurium continuous monitoring of neuromuscular block started until complete recovery of neuromuscular block.

DEVICETOF Scan on toe

The TOF Scan will be installed on hallux . After intubation dose of mivacurium continuous monitoring of neuromuscular block started until complete recovery of neuromuscular block.

DEVICETOF Scan on adductor pollicis

The TOF Scan will be installed on Thumb. After intubation dose of mivacurium continuous monitoring of neuromuscular block started until complete recovery of neuromuscular block.

DEVICETOF Scan on corrugator supercilii

The TOF Scan will be installed on corrugator supercilii. After intubation dose of mivacurium continuous monitoring of neuromuscular block started until complete recovery of neuromuscular block.

Sponsors

Regional Specialized Hospital in Olsztyn
CollaboratorUNKNOWN
University of Warmia and Mazury in Olsztyn
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Onset time1 to 10 minutesTime in seconds from start of injection of mivacurium until emergence of TOF ratio of 0%. TOF = Train of Four
Total recovery time of neuromuscular block30 to 500 minutesThe total recovery time, i.e. total duration of the neuromuscular block is defined as the time in minutes from start of injection of mivacurium until a normalized TOF ratio of 90%

Secondary

MeasureTime frameDescription
Time to repeated dose5 to 200 minutesTime in minuted from TOF ratio 0% to repeated dose

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026