Choosing the best drug for quick anesthesia induction in surgery
Best Hypnotic Drug Choice for Rapid Sequence Induction in the Operating Room: a 3-arm Randomized Trial
This study tests whether propofol, ketamine, or a mix of both can help people get safely and quickly ready for surgery while keeping their blood pressure stable.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1218 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 20 sites (Angers and 19 other locations) |
| Trial ID | NCT06733129 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of propofol, ketamine, and their combination for rapid sequence induction (RSI) in patients requiring orotracheal intubation. It aims to determine which hypnotic agent provides optimal intubation conditions while maintaining hemodynamic stability. The study is randomized and controlled, focusing on achieving successful intubation on the first attempt without significant hypotension. Participants will be monitored closely during the procedure to assess outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with risk factors for aspiration who require orotracheal intubation during general anesthesia.
Not a fit: Patients with predicted impossible tracheal intubation or significant airway modifications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the safety and effectiveness of anesthesia induction in patients at risk for aspiration.
How similar studies have performed: Previous studies have explored similar approaches, but this specific comparison of propofol and ketamine in RSI is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age between 18 - 80 years' old * female\* and male * ≥ 1 risk factor of aspiration of gastric contents defined as * preoperative fasting period of less than 6 hours, * occlusive syndrome, functional ileus, vomiting episode within the last 12 hours, * orthopaedic trauma within the last 12 hours, * medical history of symptomatic gastroesophageal reflux or hiatus, hernia or gastroparesis or dysautonomia or gastroesophageal surgery with sphincter dysfunction) * patient requiring orotracheal intubation during general anaesthesia in the operating room. * patient or his/her next of kin written informed consent or emergency procedure * failure to discontinue GLP1 analogue as recommended (exenatide, liraglutide, albiglutide, taspoglutide, lixisenatide) Exclusion Criteria: * predicted impossible tracheal intubation (≥ 1 of the following criteria: patient with known intubation complications, Mallampati score IV, Thyromental Distance ≤ 4.0 cm, Mouth Opening \< 3 cm, Sternomental Distance \< 12.5 cm, significant modification of the airway due to congenital, cancer, trauma or burning lesions (non-exhaustive list)) \[30\] * preoperative arterial hypotension (MAP \< 65 mmHg or under catecholamine) * preoperative respiratory distress syndrome (SpO2 \< 90% in room air) * contraindications to the use of ketamine and/or propofol and/or NMB: * allergy to the active substance or to one of the excipients or to soy or peanuts, * porphyria * intracranial hypertension * uncontrolled arterial hypertension (systolic arterial pressure \> 180 mmHg) * personal or family history of known malignant hyperthermia, congenital muscular dystrophy, myasthenia, a known congenital deficit in plasma pseudocholinesterase * pregnancy or breast-feeding woman * patients under court protection or guardianship * absence of insurance covering health costs
Where this trial is running
Angers and 19 other locations
- Chr Angers — Angers, France (Recruiting)
- CHRU de Brest Hôpital Cavale Blanche — Brest, France (Recruiting)
- Ch Louis Pasteur — Chartres, France (Not_yet_recruiting)
- CHU Dijon — Dijon, France (Recruiting)
- CHU Grenoble Alpes — Grenoble, France (Not_yet_recruiting)
- CHD Vendée — La Roche-sur-Yon, France (Recruiting)
- APHP Bicêtre — Le Kremlin-Bicêtre, France (Not_yet_recruiting)
- CH Le Mans — Le Mans, France (Recruiting)
- CHU Lille Hopital Salengro — Lille, France (Recruiting)
- CHU Lille Hôpital Claude Huriez — Lille, France (Recruiting)
- CHU Lyon Hôpital Sud — Lyon, France (Not_yet_recruiting)
- HCL Lyon Croix-Rousse — Lyon, France (Not_yet_recruiting)
- Chu Nantes (Laennec) — Nantes, France (Recruiting)
- Chu Nantes — Nantes, France (Recruiting)
- APHP St-Antoine — Paris, France (Not_yet_recruiting)
- APHP Tenon — Paris, France (Not_yet_recruiting)
- CHU Poitiers — Poitiers, France (Recruiting)
- Hopital Foch — Suresnes, France (Recruiting)
- CHU Toulouse Hôpital Purpan — Toulouse, France (Not_yet_recruiting)
- CHU Toulouse Hôpital Rangueil — Toulouse, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Nicolas GRILLOT, MD
- Email: nicolas.grillot@chu-nantes.fr
- Phone: 02 53 48 22 24
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.