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Best hypnotic drug choice for rapid sequence induction in the operating room: a 3-arm randomized trial open-labelled with blinded evaluation of the primary outcome
EU CTIS ID: 2024-517582-16-00
What this study is testing
compare the efficacies of ketamine alone and ketamine-propofol combination compared to standard doses of propofol to achieve successful tracheal intubation on the first attempt without severe hemodynamic hypotension in patients at risk of aspiration of gastric contents in the operating room
- Therapeutic confirmatory (Phase III)
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
- 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, failure to discontinue GLP1 analogue as recommended (exenatide, liraglutide, albiglutide, taspoglutide, lixisenatide)
- patient requiring orotracheal intubation during general anaesthesia in the operating room
- patient or his/her next of skin written informed consent or emergency procedure
You likely can't join if
- 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))
- 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
- pregnancy or breast-feeding woman
- patients under court protection or guardianship
See the full eligibility 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, failure to discontinue GLP1 analogue as recommended (exenatide, liraglutide, albiglutide, taspoglutide, lixisenatide)
- patient requiring orotracheal intubation during general anaesthesia in the operating room
- patient or his/her next of skin written informed consent or emergency procedure
- 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))
- 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
- 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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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.