CINTROI: Intubation Conditions With Atracurium After Three Minutes

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT04808440
Collaborator
(none)
100
1
5.5
18.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate intubation conditions with the use of atracurium after a fixed three-minute delay

Detailed Description

The recommended dose of a non-depolarizing curare to facilitate tracheal intubation is twice the active dose 95 (the dose that reduces muscle force by 95%). At this dosage, curarization of the laryngeal adductors allowing relaxation and abduction (opening) of the vocal cords is considered certain. With atracurium, the dose for intubation is 0.5 mg.kg-1 and the time to full effect is approximately 3 minutes. With the use of newer hypnotics, there are no data evaluating the conditions for intubation after a fixed time of 3 minutes as with current anesthetic practices.

Study Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Intubation Conditions With the Use of Atracurium After a Fixed Three-minute Delay
Actual Study Start Date :
Mar 23, 2021
Actual Primary Completion Date :
Sep 7, 2021
Actual Study Completion Date :
Sep 7, 2021

Outcome Measures

Primary Outcome Measures

  1. Intubation condition [3 minutes after atracurium injection]

    The intubating conditions were evaluated on the basis of the consensus conference on Good Clinical Research Practice in Pharmacodynamic Studies of Neuromuscular Blocking Agents. The score used include the following variables: (1) ease of laryngoscopy, (2) vocal cord position, and (3) reaction to the insertion of the endotracheal tube and the cuff inflation (eg, diaphragmatic movement due to patient cough). Each of these variables was rated as (1) excellent, (2) good, or (3) poor. Intubating conditions were scored as excellent if all variables were excellent; the score was good if at least 1 variable was good and the rest were excellent; the conditions were considered poor if any of the variables was rated poor. Evaluation of intubation conditions with the use of atracurium after a fixed three-minute delay

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adult female

  • Patient to undergo general anesthesia with intubation for scheduled gynecological surgery

  • Patient informed about the study and not opposed to it

Exclusion Criteria:
  • Patients with severe and morbid obesity (BMI>35kg/m2)

  • Pregnancy

  • Patients with difficult intubation

  • Allergy to atracurium and to any other drug used.

  • Patient under tutorship / curatorship

  • Not affiliated with social insurance

  • Patient with AME

Contacts and Locations

Locations

Site City State Country Postal Code
1 Service Anesthésie Réanimation Chirurgicale Hôpital Cochin Paris France 75014

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT04808440
Other Study ID Numbers:
  • APHP201463
First Posted:
Mar 22, 2021
Last Update Posted:
Nov 23, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Assistance Publique - Hôpitaux de Paris

Study Results

No Results Posted as of Nov 23, 2021