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Efficacy and safety of Remimazolam compared to Ketamine and Propofol in Rapid Sequence Induction. A monocentric pilot randomised-controlled study
EU CTIS ID: 2025-521602-18-00
What this study is testing
to compare the ability of remimazolam to standard doses of propofol and ketamine to achieve successful tracheal intubation on the first attempt in patients at risk of aspiration of gastric contents in the operating room
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- female and male between 18 – 80 years’ old
- ≥ 1 risk factor of aspiration of gastric contents defined as o preoperative fasting period of less than 6 hours, o occlusive syndrome, functional ileus, vomiting episode within the last 12 hours, o orthopaedic trauma within the last 12 hours, o 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
You likely can't join if
- Refusal to participate
- Patient unable to understand spoken or written French
- Predicted impossible tracheal intubation
- Preoperative hemodynamic shock (MAP < 65 mmHg or under catecholamine)
- Preoperative consciousness disorder (GCS < 12/15)
- Preoperative respiratory distress syndrome (SpO2 < 90% in room air)
See the full eligibility criteria
- female and male between 18 – 80 years’ old
- ≥ 1 risk factor of aspiration of gastric contents defined as o preoperative fasting period of less than 6 hours, o occlusive syndrome, functional ileus, vomiting episode within the last 12 hours, o orthopaedic trauma within the last 12 hours, o 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
- Refusal to participate
- Patient unable to understand spoken or written French
- Predicted impossible tracheal intubation
- Preoperative hemodynamic shock (MAP < 65 mmHg or under catecholamine)
- Preoperative consciousness disorder (GCS < 12/15)
- Preoperative respiratory distress syndrome (SpO2 < 90% in room air)
- Contraindications to the use of remimazolam and/or 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, recent stroke, unstable coronary artery disease, severe heart failure, personal or family history of known malignant hyperthermia, congenital muscular dystrophy, myasthenia, a known congenital deficit in plasma pseudocholinesterase, liver failure defined as Child-Pugh classification C, uncontrolled arterial hypertension (systolic arterial pressure > 180 mmHg)
- Pregnancy or breast-feeding woman
- Patients under court protection or guardianship
- Absence of insurance covering health costs
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.