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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-25

Study Completion Date

2021-06-30

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.

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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.

Conditions

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Neuromuscular Blockade

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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TOF Cuff on arm and TOF Scan on corrugator supercilii

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.

TOF Cuff on arm

Intervention Type DEVICE

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.

TOF Scan on corrugator supercilii

Intervention Type DEVICE

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.

TOF Cuff on lower leg and TOF Scan on adductor pollicis

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.

TOF Cuff on lower leg

Intervention Type DEVICE

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.

TOF Scan on adductor pollicis

Intervention Type DEVICE

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.

TOF Scan on adductor pollicis and TOF Scan on toe

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.

TOF Scan on toe

Intervention Type DEVICE

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.

TOF Scan on adductor pollicis

Intervention Type DEVICE

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.

TOF Scan on adductor pollicis and TOF Cuff on arm

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.

TOF Cuff on arm

Intervention Type DEVICE

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.

TOF Scan on adductor pollicis

Intervention Type DEVICE

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.

TOF Scan on adductor pollicis and TOF Scan on corrugator supercilii

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.

TOF Scan on adductor pollicis

Intervention Type DEVICE

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.

TOF Scan on corrugator supercilii

Intervention Type DEVICE

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.

Interventions

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TOF 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.

Intervention Type DEVICE

TOF 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.

Intervention Type DEVICE

TOF 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.

Intervention Type DEVICE

TOF 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.

Intervention Type DEVICE

TOF 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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes