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Completed

NCT Number: NCT03981042

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)

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU

Poitiers, France

About this study

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..

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

monitoring

Device

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

Primary outcomes

  1. The primary endpoint is the assessment of the Copenhagen score modified collected during the anesthetic induction after the intubation.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Acronym: MONITURARE

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 10, 2019
Registry last updated
Oct 21, 2019

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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