Intubation Conditions With Atracurium After Three Minutes

Completed

• Conditions: Obesity Female Patients Require General Anaesthesia With Intubation and Atracurium Curarization

• Registration Number: NCT04808440
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-22
• Study Start: 2021-03-23
• Primary Completion: 2021-09-07
• Study Completion: 2021-09-07
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-22
• Last Update Posted: 2021-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Service Anesthésie Réanimation Chirurgicale Hôpital Cochin; 🇫🇷 Paris, France