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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)

P

Poitiers University Hospital

Status

Completed

Conditions

Anesthesic Aduction
Laryngoscopy
Monitoring
Neuromuscular Blockade

Treatments

Device: Monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT03981042
2019-A00667-50

Details and patient eligibility

About

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

Full 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..

Enrollment

108 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

108 participants in 2 patient groups

Control group
No Intervention group
Description:
waiting for a 3-minute delay after injection of the atracurium before laryngoscopy
Monitoring group
Experimental group
Description:
waiting for the TOF ratio at 0 at the corrugator supercilli before laryngoscopy
Treatment:
Device: Monitoring

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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