Intubation Conditions With Atracurium After Three Minutes (CINTROI)

Evaluation of Intubation Conditions With the Use of Atracurium After a Fixed Three-minute Delay

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

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Service Anesthésie Réanimation Chirurgicale Hôpital Cochin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults, no morbid obesity female patients, without risk factors for difficult tracheal intubation (ref IOT difficile) scheduled for gynaecologic surgery were prospectively included in this observational and monocentric study.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation condition	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	3 minutes after atracurium injection

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC Necker Cochin, France

Publications and helpful links

General Publications

• Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x.
• Debaene B, Beaussier M, Meistelman C, Donati F, Lienhart A. Monitoring the onset of neuromuscular block at the orbicularis oculi can predict good intubating conditions during atracurium-induced neuromuscular block. Anesth Analg. 1995 Feb;80(2):360-3. doi: 10.1097/00000539-199502000-00026.
• Plaud B, Baillard C, Bourgain JL, Bouroche G, Desplanque L, Devys JM, Fletcher D, Fuchs-Buder T, Lebuffe G, Meistelman C, Motamed C, Raft J, Servin F, Sirieix D, Slim K, Velly L, Verdonk F, Debaene B. Guidelines on muscle relaxants and reversal in anaesthesia. Anaesth Crit Care Pain Med. 2020 Feb;39(1):125-142. doi: 10.1016/j.accpm.2020.01.005. Epub 2020 Jan 8.
• Baillard C, Tamrabet C, Ben Abdallah S, Toussaint S, Cheurfa C. Sample size considerations for studies comparing intubating conditions using quantitative monitoring versus a fixed interval during onset of neuromuscular blockade. Anaesth Crit Care Pain Med. 2022 Dec;41(6):101154. doi: 10.1016/j.accpm.2022.101154. Epub 2022 Sep 7.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2021
• Primary Completion (Actual): September 7, 2021
• Study Completion (Actual): September 7, 2021

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Tracheal intubation; Atracurium
• Other Study ID Numbers: APHP201463

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No