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)

Neuromuscular Blockade Clinical Trial

— MONITURARE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03981042
• Other study ID #: 2019-A00667-50
• Status: Completed
• Phase: N/A
• Start date: June 14, 2019
• Est. completion date: August 2, 2019

Study information

• Verified date: October 2019
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: August 2, 2019
• Est. primary completion date: August 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesic Aduction
• Laryngoscopy
• Monitoring
• Neuromuscular Blockade

Intervention

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

Locations

Country	Name	City	State
France	CHU	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)