None listed
Conditions
Brief summary
Current recommendations by the Australian and New Zealand College of Anaesthetists professional standards are that quantitative neuromuscular transmission (NMT) monitoring be used in every case of neuromuscular blockade to ensure that the reversal of muscle relaxants is adequate. However, international surveys have demonstrated that as few as 18% of anaesthetists use quantitative neuromuscular transmission (NMT) monitoring routinely. Common (38-64%) and potentially serious complication of general anaesthesia, including respiratory failure, airway collapse, aspiration of gastric contents. Electromyography (EMG) has emerged as the clinical gold standard for NMT monitoring. In particular, Tetragraph is a novel EMG-based monitor that has advantages over older monitors including availability as a stand-alone unit without the need for expensive and specially designed monitors. However, the differences in its electrode design and in-built method for waveform analysis can affect its relative performance to older monitors. Given its recent development, data regarding its relative precision and bias in different muscles of the hand are also lacking. Therefore the hypotheses is that the first dorsal interosseous (FDI) will be more precise and accurate in comparison to the other muscles of the hand and foot and that the Tetragraph, using the train of four ratio (TOF) stimulation of the ulnar nerve under general anaesthesia, will be more precise and accurate compared to the NMT Electrosensor, during spontaneous recovery from non-depolarizing neuromuscular blockade.
Interventions
Arm 1: Tetragraph Comparison in Different Muscles to Determine the Most Precise and Accurate muscle.
Objective: 1. To compare the precision and accuracy of the Tetragraph at the abductor digiti minimi (ADM), the adductor policis (AP), and the first dorsal interosseous (FDI) and the flexor hallucis brevis (FHB) muscles under general anaesthesia, during spontaneous recovery from non-depolarising neuromuscular blockade.
Materials and Procedures: Tetragraph (Acacia Designs BV, Amsterdam, Holland) i
Arm 1: Tetragraph Comparison in Different Muscles to Determine the Most Precise and Accurate muscle. Objective: 1. To compare the precision and accuracy of the Tetragraph at the abductor digiti minimi (ADM), the adductor policis (AP), and the first dorsal interosseous (FDI) and the flexor hallucis brevis (FHB) muscles under general anaesthesia, during spontaneous recovery from non-depolarising neuromuscular blockade. Materials and Procedures: Tetragraph (Acacia Designs BV, Amsterdam, Holland) is a novel EMG-based monitor that has advantages over older monitors. Availability as a stand-alone unit, with improved electrode design and surface contact. TetraSens electrodes will be utilised. There is 1 TetraSens electrode per Tetragraph. It analyses amplitude of acquired compound muscle action potentials. Written consent will be obtained from participants. Quantitative neuromuscular function monitoring is the highest standard of care and is recommended as routine by the College of Anaesthetists. There are no known risks of this monitoring. Randomisation – 1. The side each respective muscle (ADM vs FDI) will be allocated. Participants will be connected to two Tetragraphs, one one on either arm, with TetraSens electrodes. Each Tetragraph will be connected to a different muscle -ADM, FDI, AP, FHB depending on randomisation. Who Delivers Intervention: A Junior Doctor. Mode of Delivery: Face to Face Number of Times: Once - duration is length of surgery. Arm 1 will be undertaken for a minimum of a month before Arm 2 will be commenced. Location: Private Hospital Definition of the most precise and accurate muscle: Bland–Altman analysis for repeated Train Of Four measurements at hand and foot muscles will be used to determine the repeatability coefficient (precision), bias (accuracy), and limits of agreement (accuracy) at each level of recovery, divided into TOF bands. The repeatability coefficient evaluates the precision of a measurement method. A small repeatability coefficient represents high precision. Bias and limits of agreement assess agreement (accuracy) between two measurement methods. A small bias with narrow limits of agreement represents a high degree of agreement and interchangeability. Participants will undertake Arm 1 independently of Arm 2, depending on the time of enrolment. Arm 2: Comparison of two EMG monitors utilising the most precise and accurate muscle found in Arm 1. Objective: 2. To investigate the precision and accuracy between the Tetragraph and the NMT Electrosensor, using the train of four (TOF) stimulation of the ulnar nerve under general anaesthesia, during spontaneous recovery from non-depolarising neuromuscular blockade. Materials and Procedures: Tetragraph (Acacia Designs BV, Amsterdam, Holland) is a novel EMG-based monitor that has advantages over older monitors. Availability as a stand-alone unit, with improved electrode design and surface contact. TetraSens electrodes will be utilised. It analyses amplitude of acquired compound muscle action potentials. NMT Electrosensor (GE Healthcare, Helsinki, Finland is currently the most widely available EMG monitor. Use is limited by the requirement to connect to an expensive monitor designed specifically for its use alone, and analyses the area under the curve (AUC). Written consent will be obtained from participants. Quantitative neuromuscular function monitoring is the highest standard of care and is recommended as routine by the College of Anaesthetists. There are no known risks of this monitoring. Randomisation – 1. The side each respective muscle (ADM vs FDI) will be allocated. The Tetragraph will be connected with TetraSens to one muscle (the most precise and accurate found in Arm 1), and the GE NMT electrosensor will be connected on the other hand with ECG electrodes in the same muscle. Who Delivers Intervention: A Junior Doctor. Mode of Delivery: Face to Face Number of Times: Once - duration is length of surgery. Arm 1 will be undertaken for a minimum of a month before Arm 2 will be commenced. Location: Private Hospital Participants will undertake Arm 2 independently of Arm 1, depending on the time of enrolment.
Sponsors
The Sydney Adventist Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria - 18 years of age, receive neuromuscular blocking agent.
Exclusion criteria
Exclusion criteria – previous procedures or pre-existing condition where TOF ratio may not be measure accurately, allergy to adhesive gel electrodes, difficult access to the hand, neuromuscular disease.
Outcome results
None listed