NCT04845386

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2021

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

May 31, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

April 9, 2021

Last Update Submit

May 25, 2022

Conditions

Neuromuscular Blockade

Keywords

TOF CuffTOF ScanNeuromuscular transmissioncorrugator superciliiMivacuriumadductor pollicis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Time to repeated dose

    5 to 200 minutes

Study Arms (5)

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.

Device: TOF Cuff on armDevice: TOF Scan on corrugator supercilii

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.

Device: TOF Cuff on lower legDevice: TOF Scan on adductor pollicis

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.

Device: TOF Scan on toeDevice: TOF Scan on adductor pollicis

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.

Device: TOF Cuff on armDevice: TOF Scan on adductor pollicis

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.

Device: TOF Scan on adductor pollicisDevice: TOF Scan on corrugator supercilii

Interventions

TOF Cuff on armDEVICE

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 arm and TOF Scan on corrugator superciliiTOF Scan on adductor pollicis and TOF Cuff on arm
TOF Cuff on lower legDEVICE

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 Cuff on lower leg and TOF Scan on adductor pollicis
TOF Scan on toeDEVICE

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 and TOF Scan on toe
TOF Scan on adductor pollicisDEVICE

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 Cuff on lower leg and TOF Scan on adductor pollicisTOF Scan on adductor pollicis and TOF Cuff on armTOF Scan on adductor pollicis and TOF Scan on corrugator superciliiTOF Scan on adductor pollicis and TOF Scan on toe
TOF Scan on corrugator superciliiDEVICE

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 arm and TOF Scan on corrugator superciliiTOF Scan on adductor pollicis and TOF Scan on corrugator supercilii

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In the study will take patients qualified to the elective surgery

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology and Intensive Care Clinical Ward, Regional Specialized Hospital

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

Location

Related Publications (1)

  • Radkowski P, Rusc J, Keska M, Onichimowski D. Comparison of TOF scan neuromuscular monitoring on adductor pollicis vs. corrugator supercilii and flexor hallucis brevis. Sci Rep. 2025 Jul 14;15(1):25426. doi: 10.1038/s41598-025-11259-5.

    PMID: 40659829DERIVED

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 9, 2021

First Posted

April 15, 2021

Study Start

March 25, 2021

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

May 31, 2022

Record last verified: 2022-05

Locations

PL(1)