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
|Condition or disease||Intervention/treatment||Phase|
|Laryngoscopy Anesthesic Aduction Neuromuscular Blockade Monitoring||Device: Monitoring||Not Applicable|
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..
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
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
- 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.
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
|Contact: Mathieu BOISSON, Drfirstname.lastname@example.org|
|Contact: Mathieu BOISSON, Dr 05.49.44.46.35 email@example.com|