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)

NCT03981042 | Completed

• 1 other identifier: 2019-A00667-50
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Conditions

Laryngoscopy; Anesthesic Aduction; Neuromuscular Blockade; Monitoring

Keywords

laryngoscopy; anesthesic aduction; neuromuscular blockade monitoring

Outcome Measures

Primary Outcomes (1)

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

  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)

Study Arms (2)

Control group

NO INTERVENTION

waiting for a 3-minute delay after injection of the atracurium before laryngoscopy

Monitoring group

EXPERIMENTAL

waiting for the TOF ratio at 0 at the corrugator supercilli before laryngoscopy

Device: Monitoring

Interventions

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

Monitoring group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU

Poitiers, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: June 10, 2019
• Study Start: June 14, 2019
• Primary Completion: August 2, 2019
• Study Completion: August 2, 2019
• Last Updated: October 21, 2019

Record last verified: 2019-10

Locations

FR (1)