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

Completed

• Conditions: Neuromuscular Blockade
• Interventions: Device: TOF Cuff on lower leg; Device: TOF Scan on toe; Device: TOF Cuff on arm; Device: TOF Scan on adductor pollicis; Device: TOF Scan on corrugator supercilii

• Registration Number: NCT04845386
• Lead Sponsor: University of Warmia and Mazury in Olsztyn

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.

Study Timeline

• Study Start: 2021-03-25
• Study First Submitted: 2021-04-09
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-15
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-25
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TOF Cuff on lower leg and TOF Scan on adductor pollicis	TOF Cuff on lower leg	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 and TOF Scan on toe	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 Cuff on lower leg and TOF Scan on adductor pollicis	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 Scan on adductor pollicis and TOF Scan on toe	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 Scan on adductor pollicis and TOF Cuff on arm	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 arm and TOF Scan on corrugator supercilii	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 and TOF Scan on corrugator supercilii	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 and TOF Cuff on arm	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 Scan on adductor pollicis and TOF Scan on corrugator supercilii	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 Scan on adductor pollicis and TOF Scan on corrugator supercilii	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.

Primary Outcome Measures

Name	Time	Method
Onset time	1 to 10 minutes	Time in seconds from start of injection of mivacurium until emergence of TOF ratio of 0%. TOF = Train of Four
Total recovery time of neuromuscular block	30 to 500 minutes	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%

Secondary Outcome Measures

Name	Time	Method
Time to repeated dose	5 to 200 minutes	Time in minuted from TOF ratio 0% to repeated dose

Trial Locations

Locations (1)

Anesthesiology and Intensive Care Clinical Ward, Regional Specialized Hospital; 🇵🇱 Olsztyn, Warmia-Mazury, Poland