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

University of Warmia and Mazury in Olsztyn

Status: Completed

Conditions: Neuromuscular Blockade

Treatments: Device: TOF Scan on corrugator supercilii; Device: TOF Scan on toe; Device: TOF Cuff on lower leg; Device: TOF Cuff on arm; Device: TOF Scan on adductor pollicis

Study type: Observational

Funder types: Other

Identifiers

NCT04845386

Mivacron 2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

128 participants in 5 patient groups

TOF Cuff on arm and TOF Scan on corrugator supercilii

Description:

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.

Treatment:

Device: TOF Scan on corrugator supercilii

Device: TOF Cuff on arm

TOF Cuff on lower leg and TOF Scan on adductor pollicis

Description:

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.

Treatment:

Device: TOF Scan on adductor pollicis

Device: TOF Cuff on lower leg

TOF Scan on adductor pollicis and TOF Scan on toe

Description:

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.

Treatment:

Device: TOF Scan on adductor pollicis

Device: TOF Scan on toe

TOF Scan on adductor pollicis and TOF Cuff on arm

Description:

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.

Treatment:

Device: TOF Cuff on arm

Device: TOF Scan on adductor pollicis

TOF Scan on adductor pollicis and TOF Scan on corrugator supercilii

Description:

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.

Treatment:

Device: TOF Scan on corrugator supercilii

Device: TOF Scan on adductor pollicis