- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03981042
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)
Study Overview
Status
Intervention / Treatment
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..
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Poitiers, France
- CHU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Few minutes after intubation (about 5 minutes)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2019-A00667-50
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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