Clinical Trials Directory

Trials / Completed

CompletedNCT03981042

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)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
108 (actual)
Sponsor
Poitiers University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

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..

Conditions

Interventions

TypeNameDescription
DEVICEMonitoringAfter 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

Timeline

Start date
2019-06-14
Primary completion
2019-08-02
Completion
2019-08-02
First posted
2019-06-10
Last updated
2019-10-21

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03981042. Inclusion in this directory is not an endorsement.