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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. So, we designed the HyPnotiKs randomized controlled study to investigate the efficacy of these hypnotic drugs in patients undergoing RSI in the operating theatre. The primary endpoint will be the successful tracheal intubation at the first attempt without major arterial hypotension event.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KETOFOL | Experimental | Ketofol: combination of Ketamine and Propofol : consecutive direct IV injection of Ketamine 1 mg/kg and Propofol 1 mg/kg after completing pre-oxygenation |
|
| KETAMINE | Experimental | direct IV injection at dosage of 2 mg/kg after completing pre-oxygenation |
|
| PROPOFOL | Active Comparator | direct IV injection at dosage of 2 mg/kg after completing pre-oxygenation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| direct IV injection | Drug | direct IV injection at dosage of 2 mg/kg (adjusted body weight if BMI > 30) after completing pre-oxygenation |
|
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients with successful intubation at first attempt and without post-induction hypotension | The main objective of the study is to 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 hemodynamic hypotension in patients at risk of aspiration of gastric contents in the operating room. The composite primary outcome is the proportion of patients with successful intubation at first attempt and without post-induction hypotension defined by a mean arterial pressure ≤ 60 mmHg within 10 minutes after the start of the hypnotic injection. | within 10 minutes after the start of the hypnotic injection |
| Measure | Description | Time Frame |
|---|---|---|
| rates of arterial hypotension episodes | rates of arterial hypotension episodes as defined in primary endpoint within 10 minutes after induction of anaesthesia compared between the three study groups | within 10 minutes after the start of the hypnotic injection |
| rates of tracheal intubation at the first attempt |
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Inclusion Criteria:
age between 18 - 80 years' old
female* and male
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:
pregnancy or breast-feeding woman
patients under court protection or guardianship
absence of insurance covering health costs
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas GRILLOT, MD | Contact | 02 53 48 22 24 | +33 | nicolas.grillot@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chr Angers | Recruiting | Angers | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41546091 | Derived | Grillot N, Volteau C, Quillet P, Ambrosi X, Caillard A, David JS, Blet A, Bouzat P, Blanchet L, Bruneau N, Chebbi N, Saint-Genis Q, Figueiredo S, Guinot PG, Joosten A, Le Guen M, Labaste F, Lasocki S, Oudot M, Pommier M, Rousseleau D, Verdonk F, Tching-Sin M, Faurel-Paul E, Counille F, Cosse C, Flattres Duchaussoy D, Cinotti R, Roquilly A. Best hypnotic drug choice for rapid sequence induction in the operating room: study protocol for a 3-arm superiority open-labeled randomized controlled trial with blinded evaluation of the primary outcome (the HyPnotiKs study). Trials. 2026 Jan 16;27(1):127. doi: 10.1186/s13063-026-09452-6. |
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| combination of Ketamine and Propofol | Drug | combination of Ketamine and Propofol described above: consecutive direct IV injection of Ketamine 1 mg/kg and Propofol 1 mg/kg (adjusted body weight if BMI > 30). Dilution are not necessary. |
|
rates of tracheal intubation at the first attempt compared between the three study groups |
| within 10 minutes after the start of the hypnotic injection |
| quality of the intubation | In the operating theatre (within 10 minutes after the start of the hypnotic injection): intubation difficulty scale (IDS-3) values | within 10 minutes after the start of the hypnotic injection |
| quality of the intubation | In the operating theatre (within 10 minutes after the start of the hypnotic injection): Cormack-Lehane score values (from 1 to 4)
| within 10 minutes after the start of the hypnotic injection |
| rates of vasopressor use and volume of intravenous fluids for vascular filling (from entry into the operating theatre to induction and from induction to recovery room) | In the operating theatre (within 10 minutes after the start of the hypnotic injection): rates of vasopressor use and volume of intravenous fluids for vascular filling (from entry into the operating theatre to induction and from induction to recovery room) | within 10 minutes after the start of the hypnotic injection |
| volume of intravenous fluids for vascular filling | volume of intravenous fluids for vascular filling (from entry into the operating theatre to induction and from induction to recovery room) | up to relapse of the recovery room (up to 7 days after surgery) |
| time between administration of hypnotic and tracheal intubation | Efficacy of ketamine and / or ketamine-propofol combination compared to standard doses of propofol on the prevention of postoperative complications in the operating theatre (within 10 minutes after the start of the hypnotic injection) : - time between administration of hypnotic (start of anesthetic induction) and tracheal intubation (defined as the 6th capnography curve) | within 10 minutes after the start of the hypnotic injection |
| values of heart rate | Efficacy of ketamine and / or ketamine-propofol combination compared to standard doses of propofol on the prevention of postoperative complications in the operating theatre (within 10 minutes after the start of the hypnotic injection) : values of heart rate measured every 1 minute from pre-oxygenation to 10 minutes after the start of the hypnotic injection | within 10 minutes after the start of the hypnotic injection |
| values of SpO2 | Efficacy of ketamine and / or ketamine-propofol combination compared to standard doses of propofol on the prevention of postoperative complications in the operating theatre (within 10 minutes after the start of the hypnotic injection): SpO2 measured every 1 minute from pre-oxygenation to 10 minutes after the start of the hypnotic injection | within 10 minutes after the start of the hypnotic injection |
| values of blood pressure | Efficacy of ketamine and / or ketamine-propofol combination compared to standard doses of propofol on the prevention of postoperative complications in the operating theatre (within 10 minutes after the start of the hypnotic injection): systolic/diastolic/mean blood pressure measured every 1 minute from pre-oxygenation to 10 minutes after the start of the hypnotic injection | within 10 minutes after the start of the hypnotic injection |
| rates of pulmonary aspiration of gastric contents | Efficacy of ketamine and / or ketamine-propofol combination compared to standard doses of propofol on the prevention of postoperative complications in the operating theatre (within 10 minutes after the start of the hypnotic injection): rates of pulmonary aspiration of gastric contents during the intubation procedure | within 10 minutes after the start of the hypnotic injection |
| Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol | Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol in the recovery room by postoperative Nu-DESC (Nursing Delirium Screening Scale) score value compared with preoperative score From 0 to 10 | during stay in the recovery room |
| Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol | Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol in the recovery room: need of sedative therapy in the recovery room to treat a delirium episode. | during stay in the recovery room |
| Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol | Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol in the recovery room: Use of ketamine and total dose during intervention and total dose of ketamine in recovery room. | during stay in the recovery room (up to 7 days after induction) |
| Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol | Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol in the recovery room: Up to day 7:
| within 7 days after the start of the hypnotic injection |
| CHRU de Brest Hôpital Cavale Blanche | Recruiting | Brest | France |
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| Ch Louis Pasteur | Not yet recruiting | Chartres | France |
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| CHU Dijon | Recruiting | Dijon | France |
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| CHU Grenoble Alpes | Not yet recruiting | Grenoble | France |
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| CHD Vendée | Recruiting | La Roche-sur-Yon | France |
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| APHP Bicêtre | Not yet recruiting | Le Kremlin-Bicêtre | France |
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| CH Le Mans | Recruiting | Le Mans | France |
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| CHU Lille Hopital Salengro | Recruiting | Lille | France |
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| CHU Lille Hôpital Claude Huriez | Recruiting | Lille | France |
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| CHU Lyon Hôpital Sud | Not yet recruiting | Lyon | France |
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| HCL Lyon Croix-Rousse | Not yet recruiting | Lyon | France |
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| Chu Nantes (Laennec) | Recruiting | Nantes | 44093 | France |
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| Chu Nantes | Recruiting | Nantes | 44093 | France |
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| APHP St-Antoine | Not yet recruiting | Paris | France |
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| APHP Tenon | Not yet recruiting | Paris | France |
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| CHU Poitiers | Recruiting | Poitiers | France |
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| Hopital Foch | Recruiting | Suresnes | France |
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| CHU Toulouse Hôpital Purpan | Not yet recruiting | Toulouse | France |
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| CHU Toulouse Hôpital Rangueil | Not yet recruiting | Toulouse | France |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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