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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
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Tracking Information
First Submitted Date  ICMJE April 24, 2019
First Posted Date  ICMJE June 10, 2019
Last Update Posted Date June 24, 2019
Actual Study Start Date  ICMJE June 14, 2019
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03981042 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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)
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
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Laryngoscopy
  • Anesthesic Aduction
  • Neuromuscular Blockade
  • Monitoring
Intervention  ICMJE 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

Study Arms  ICMJE
  • 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
    Intervention: Device: Monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 7, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2, 2019
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mathieu BOISSON, Dr 05.49.44.46.35 matthieu.boisson@chu-poitiers.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03981042
Other Study ID Numbers  ICMJE 2019-A00667-50
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Poitiers University Hospital
Study Sponsor  ICMJE Poitiers University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Poitiers University Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP