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Completed

NCT Number: NCT04845386

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

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Anesthesiology and Intensive Care Clinical Ward, Regional Specialized Hospital

Olsztyn, Warmian-Masurian Voivodeship, 10-561, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TOF Cuff on arm

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 Cuff on lower leg

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 toe

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

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

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.

Primary outcomes

  1. Onset time

    Time frame: 1 to 10 minutes

    Time in seconds from start of injection of mivacurium until emergence of TOF ratio of 0%. TOF = Train of Four

  2. Total recovery time of neuromuscular block

    Time frame: 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 outcomes

  1. Time to repeated dose

    Time frame: 5 to 200 minutes

    Time in minuted from TOF ratio 0% to repeated dose

Sponsors and collaborators

Lead sponsor

University of Warmia and Mazury in Olsztyn

Other

Collaborators

  • Regional Specialized Hospital in Olsztyn

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 15, 2021
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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