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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Neuromuscular Blockade

Intervention / Treatment
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* Device: TOF Cuff on arm
* Device: TOF Cuff on lower leg
* Device: TOF Scan on toe
* Device: TOF Scan on adductor pollicis
* Device: TOF Scan on corrugator supercilii


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TOF Cuff on arm and TOF Scan on corrugator supercilii<br>Patients undergoing surgery with intubation and receiving a intubation dose of mivacurium (0.2 mg/kg) and repeated dose of mivacurium (2mg) depending of needing under, routine gas anesthesia will have monitoring of neuromuscular block with two monitors simultaneously. | Device: TOF Cuff on arm<br>* 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.<br>Device: TOF Scan on corrugator supercilii<br>* 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.<br>|
| TOF Cuff on lower leg and TOF Scan on adductor pollicis<br>Patients undergoing surgery with intubation and receiving a intubation dose of mivacurium (0.2 mg/kg) and repeated dose of mivacurium (2mg) depending of needing under, routine gas anesthesia will have monitoring of neuromuscular block with two monitors simultaneously. | Device: TOF Cuff on lower leg<br>* 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.<br>Device: TOF Scan on adductor pollicis<br>* 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.<br>|
| TOF Scan on adductor pollicis and TOF Scan on toe<br>Patients undergoing surgery with intubation and receiving a intubation dose of mivacurium (0.2 mg/kg) and repeated dose of mivacurium (2mg) depending of needing under, routine gas anesthesia will have monitoring of neuromuscular block with two monitors simultaneously. | Device: TOF Scan on toe<br>* 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.<br>Device: TOF Scan on adductor pollicis<br>* 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.<br>|
| TOF Scan on adductor pollicis and TOF Cuff on arm<br>Patients undergoing surgery with intubation and receiving a intubation dose of mivacurium (0.2 mg/kg) and repeated dose of mivacurium (2mg) depending of needing under, routine gas anesthesia will have monitoring of neuromuscular block with two monitors simultaneously. | Device: TOF Cuff on arm<br>* 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.<br>Device: TOF Scan on adductor pollicis<br>* 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.<br>|
| TOF Scan on adductor pollicis and TOF Scan on corrugator supercilii<br>Patients undergoing surgery with intubation and receiving a intubation dose of mivacurium (0.2 mg/kg) and repeated dose of mivacurium (2mg) depending of needing under, routine gas anesthesia will have monitoring of neuromuscular block with two monitors simultaneously. | Device: TOF Scan on adductor pollicis<br>* 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.<br>Device: TOF Scan on corrugator supercilii<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset time | Time in seconds from start of injection of mivacurium until emergence of TOF ratio of 0%. TOF = Train of Four | 1 to 10 minutes | 
| Total recovery time of neuromuscular block | The 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% | 30 to 500 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to repeated dose | Time in minuted from TOF ratio 0% to repeated dose | 5 to 200 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TOF Cuff, TOF Scan, Neuromuscular transmission, corrugator supercilii, Mivacurium, adductor pollicis