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New treatment option for Rapid Sequence Induction
Official title Best Hypnotic Drug Choice for Rapid Sequence Induction in the Operating Room
ClinicalTrials.gov ID: NCT06733129
What this study is testing
What is direct IV injection?
direct IV injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for rapid sequence induction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The best hypnotic choice to optimize the balance between good intubation condition quality and hemodynamic stability during RSI performed in the operating theatre remained to be investigated. Therefore, a randomized study evaluating the efficacy of propofol, ketamine, and a combination of both is appropriate.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
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,
You likely can't join if
- predicted impossible tracheal intubation (≥ 1 of the following criteria: patient with known intubation complications, Mallampati score IV...
- 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
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)
- 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)
- 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 \<...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Brest, France
- Chartres, France
- Dijon, France
- Grenoble, France
- La Roche-sur-Yon, France
- Le Kremlin-Bicêtre, France
- Le Mans, France
- Lille, France
- Lyon, France
- Nantes, France
- Paris, France
- Poitiers, France
- Suresnes, France
- Toulouse, France
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 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Brest, France; Chartres, France; Dijon, France; Grenoble, France; La Roche-sur-Yon, France and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.