Choosing the best drug for quick anesthesia induction in surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Chr Angers
  Angers, France Recruiting
• CHRU de Brest Hôpital Cavale Blanche
  Brest, France Recruiting
• CHU Dijon
  Dijon, France Recruiting
• CHD Vendée
  La Roche-sur-Yon, France Recruiting
• CH Le Mans
  Le Mans, France Recruiting
• CHU Lille Hopital Salengro
  Lille, France Recruiting

Study contacts

• Study coordinator: Nicolas GRILLOT, MD
• Email: nicolas.grillot@chu-nantes.fr
• Phone: 02 53 48 22 24

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.