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

Neuromuscular Blockade Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04845386
• Other study ID #: Mivacron 2021
• Status: Completed
• Start date: March 25, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: May 2022
• Source: University of Warmia and Mazury in Olsztyn
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Device:
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Poland	Anesthesiology and Intensive Care Clinical Ward, Regional Specialized Hospital	Olsztyn	Warmia-Mazury

Sponsors (2)

Lead Sponsor	Collaborator
University of Warmia and Mazury in Olsztyn	Regional Specialized Hospital in Olsztyn

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Time to repeated dose	Time in minuted from TOF ratio 0% to repeated dose	5 to 200 minutes