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Comparison Between the Neuromuscular Blockade Onset Monitoring and the Expectation of a Fixed Delay After Curarization on the Quality of Laryngoscopy During Intubation in Elective Surgery (MONITURARE)

Comparison Between the Neuromuscular Blockade Onset Monitoring and the Expectation of a Fixed Delay After Curarization on the Quality of Laryngoscopy During Intubation in Elective Surgery (MONITURARE)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03981042
Acronym
MONITURARE
Enrollment
108
Registered
2019-06-10
Start date
2019-06-14
Completion date
2019-08-02
Last updated
2019-10-21

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

Conditions

Anesthesic Aduction, Laryngoscopy, Monitoring, Neuromuscular Blockade

Keywords

laryngoscopy, anesthesic aduction, neuromuscular blockade monitoring

Brief summary

During anesthetic induction, the relevance of neuromuscular blockade (NMB) onset monitoring cannot be asserted and its superiority over waiting for a fixed delay (corresponding to pharmacokinetic knowledge of the neuromuscular blocking agent used) has not been proven. However, many studies have shown a large inter-individual variability on the delay of the NMB onset. The main objective of othe investigator's study is to compare the quality of laryngoscopy during intubation between the NMB onset monitoring and the expectation of a fixed delay after curarization

Detailed description

French guidelines on curarization, updated in 2018, do not recommend the NMB onset monitoring due to a lack of data in the literature. Thus, the interest of monitoring cannot be asserted and its superiority over waiting for a fixed delay has not been proven. Due to a large inter-individual variability on the delay of the NMB onset after administration of atracurium, the relevance of monitoring NMB during an anesthetic induction should be assessed to improve the quality of laryngoscopy. In case of monitoring, the experts recommend monitoring the NMB onset at the corrugator supercilli because it reflects neuromuscular blockade at the laryngeal adductor muscles. During the pre-anaesthetic visit, patients will be enrolled after inform consent. Patients will be randomized in two groups, control group (waiting for a 3-minute delay after injection of atracurium) or monitoring group (waiting for the TOF ratio at 0 at the corrugator supercilli). Anesthetic induction will be performed with sufentanil, propofol and atracurium. After laryngoscopy, the primary outcome will be evaluated using Copenhagen score. Patients will be followed up until they leave the recovery room..

Interventions

DEVICEMonitoring

After the anesthetic induction with sufentanil, propofol and atracurium, patients will be ventilated with mask until: \- Monitoring group: TOF ratio at the corrugator supercilli will be measured every 15 s after injection of atracurium. When TOF ratio reach 0, laryngoscopy with intubation will be performed

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

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

Inclusion criteria

* Adult patients (≥ 18 years), both sexes * Any elective surgery requiring injection of atracurium * Free patient, without guardianship or subordination * Patients with a social security coverage * Informed and signed consent after clear and fair information

Exclusion criteria

* Rapid sequence induction * Predictable difficult intubation * Use of a neuromuscular blockade agent other than atracurium * Known contraindication to a neuromuscular blockade agent

Design outcomes

Primary

MeasureTime frameDescription
The primary endpoint is the assessment of the Copenhagen score modified collected during the anesthetic induction after the intubation.Few minutes after intubation (about 5 minutes)The primary endpoint is the assessment of the Copenhagen score modified collected during the anesthetic induction after the intubation.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026