Clinical trial NCT04808440: Intubation Conditions With Atracurium After Three Minutes
Official title: Evaluation of Intubation Conditions With the Use of Atracurium After a Fixed Three-minute Delay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity Female Patients Require General Anaesthesia With Intubation and Atracurium Curarization
Keywords: Tracheal intubation
Atracurium
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intubation condition
timeFrame: 3 minutes after atracurium injection
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Service Anesthésie Réanimation Chirurgicale Hôpital Cochin
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.