Evaluation of REMIFENTANIL as an alternative to curare for rapid sequence anesthetic induction in patients at risk of gastric fluid inhalatio

Phase 1

• Conditions: anesthetic induction; MedDRA version: 20.0Level: LLTClassification code 10002326Term: Anesthetic inductionSystem Organ Class: 100000004865; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2019-000753-31-FR
• Lead Sponsor: CHU Nantes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-14
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1150

Inclusion Criteria

- Female or male.
- Aged 18 to 80 years old
- Intervention requiring general anesthesia with orotracheal intubation
- Anesthetic management with indication of induction in rapid sequence
- Risk of gastric fluid inhalation defined by at least one of the following criteria: fasting period < 6:00 am, digestive obstruction, functional ileus, vomiting < 12:00 pm orthopedic trauma < 12:00 pm, history of severe GERD and/or hiatal hernia and/or gastroparesis and/or dysautonomy and/or gastroesophageal surgery
- Existence of informed and signed consent from the patient, or in the absence of an emergency procedure

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 850
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

- impossible Intubation planned
- Known or suspected history of allergy to curares and/or remifentanil
- History of neuromuscular disease contraindicating the use of curares
- History of residual curarization
- History of malignant hyperthermia
- Preoperative respiratory distress (SpO2 < 95% in ambient air)
- Preoperative shock (under vasopressor amines)
- Patient in cardiorespiratory arrest
- A woman of childbearing potential and of childbearing potential who has an ongoing pregnancy and/or clinical signs suggestive of an ongoing pregnancy and/or who does not have a contraceptive or contragestive method and has had unprotected sexual relations within 15 days after the last menstrual period.
- Patients under guardianship or curatorship
- Intended use of ETOMIDATE for rapid sequence induction

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified