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Muscle Relaxation and Endotracheal Intubation: Textbook or Evidence Based? (Relaxed Study)

Observational study to investigate the degree of muscle relaxation at the time of endotracheal intubation after a routine anaesthetic induction in adult patients scheduled for elective surgery: textbook or evidence based? (Relaxed Study)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620001045909
Enrollment
78
Registered
2020-10-15
Start date
2019-02-04
Completion date
Unknown
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

When patients undergo surgery with general anaesthesia, the anaesthetist places a plastic tube into the windpipe after the patient is put into sleep. At this time, deep muscle relaxation is required to prevent some bad reflex responses to this procedure, such as coughing and bulking on the tube. However, in daily practice it is not practical to monitor every patient so closely who receives the muscle relaxant drugs, especially during the anaesthetic induction period when the tube is placed into the windpipe after patient is anaesthetized, as this is the most intense and stressful period for the anaesthetist. As such, a majority of anaesthetists routinely use the standard dose of the relaxant drugs and place the tube into the windpipe at the set time point according to the drugs’ respective “product information”. Such practice works for most patients, but some patients may have different sensitivity to the muscle relaxant drugs, and thus it may take longer time than normal to have deep muscle relaxation. This time lag may result in the tube being placed into the windpipe too early and thus cause some unwanted body reactions. These reactions may be very bad for certain patients, for example, if the patient has existing high blood pressure. In order to prevent such premature placement of the windpipe tube, we need to first find out how bad the problem is, i.e., how prevalent the premature placement of the windpipe tube is during standard anaesthetics induction, this is measured by a digital peripheral nerve stimulator, quantifying the degree of muscle relaxation. The good time to place the tube into the windpipe is when none of the four twitches appear on Train-Of-Four (TOF) stimulation of a nerve stimulator, applied to the patient's wrist before anaesthesia. The prevalence of premature placement of the windpipe tube is determined by the percentage of patients whose tube is placed before the disappearance of TOF on the nerve stimulator. This is what our study aims to do and only after we have determined the problem's prevalence, we will then be able to make recommendations accordingly so that we can modify and improve our patient care.

Interventions

When neuromuscular monitoring is used, ‘optimal’ intubating conditions for laryngoscopy and endotracheal intubation (ETI) are indicated by the disappearance of the Train-of-Four Count (TOFC=0) measured by a digital peripheral nerve stimulator (PNS); if intubated prior to this point, i.e., TOFC=0, such intubation condition is defined as "suboptimal". Prior to anaesthetic induction, a quantitative PNS (TOFscan, IDMED, France) will be applied to the patient’s ulnar nerve at the wrist for the purpos

When neuromuscular monitoring is used, ‘optimal’ intubating conditions for laryngoscopy and endotracheal intubation (ETI) are indicated by the disappearance of the Train-of-Four Count (TOFC=0) measured by a digital peripheral nerve stimulator (PNS); if intubated prior to this point, i.e., TOFC=0, such intubation condition is defined as "suboptimal". Prior to anaesthetic induction, a quantitative PNS (TOFscan, IDMED, France) will be applied to the patient’s ulnar nerve at the wrist for the purpose of adductor pollicis muscle stimulation. The non-depolarising neuromuscular blocking agent (NDNMBA), dosage and the time to attempt ETI after drug administration will remain at the Anesthetist’s discretion. At the time of ETI, TOF stimulation is activated and auto TOF will repeat every 30 seconds. If the Anesthetist would elect to use neuromuscular monitoring as part of their usual practice, the TOF results will not be blinded. All time-points with TOF-ratio (TOFR) and TOFC will be recorded on site into a standardised data collection sheet until the TOFC reaches '0' or 30 minutes after NDNMBA administration, whichever comes first, at which point data collection will be ceased.

Sponsors

Dr Aihua Wu
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

adult patients scheduled for elective surgery at our hospital with an Anaesthetic management plan of endotracheal intubation facilitated by use of a NDNMBA

Exclusion criteria

patient refusal younger than 18 years old language barrier dementia or intellectual disability

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026