Obesity Female Patients Require General Anaesthesia With Intubation and Atracurium Curarization Clinical Trial
— CINTROIOfficial title:
Evaluation of Intubation Conditions With the Use of Atracurium After a Fixed Three-minute Delay
| NCT number | NCT04808440 |
| Other study ID # | APHP201463 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 23, 2021 |
| Est. completion date | September 7, 2021 |
| Verified date | November 2021 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this study is to evaluate intubation conditions with the use of atracurium after a fixed three-minute delay
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | September 7, 2021 |
| Est. primary completion date | September 7, 2021 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Service Anesthésie Réanimation Chirurgicale Hôpital Cochin | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |