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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) (MONITURARE)

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ClinicalTrials.gov Identifier: NCT03981042
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

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

Condition or disease Intervention/treatment Phase
Laryngoscopy Anesthesic Aduction Neuromuscular Blockade Monitoring Device: Monitoring Not Applicable

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..


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: 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)
Actual Study Start Date : June 14, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 2, 2019

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

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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03981042


Contacts
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Contact: Mathieu BOISSON, Dr 05.49.44.46.35 matthieu.boisson@chu-poitiers.fr

Locations
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France
CHU Recruiting
Poitiers, France
Contact: Mathieu BOISSON, Dr    05.49.44.46.35    mathieu.boisson@chu-poitiers.fr   
Sponsors and Collaborators
Poitiers University Hospital

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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03981042     History of Changes
Other Study ID Numbers: 2019-A00667-50
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Poitiers University Hospital:
laryngoscopy
anesthesic aduction
neuromuscular blockade monitoring

Additional relevant MeSH terms:
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Atracurium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action