Best Hypnotic Drug Choice for Rapid Sequence Induction in the Operating Room
NCT ID: NCT06733129
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1218 participants
INTERVENTIONAL
2025-04-14
2027-04-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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KETOFOL
Ketofol: combination of Ketamine and Propofol : consecutive direct IV injection of Ketamine 1 mg/kg and Propofol 1 mg/kg after completing pre-oxygenation
combination of Ketamine and Propofol
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.
KETAMINE
direct IV injection at dosage of 2 mg/kg after completing pre-oxygenation
direct IV injection
direct IV injection at dosage of 2 mg/kg (adjusted body weight if BMI \> 30) after completing pre-oxygenation
PROPOFOL
direct IV injection at dosage of 2 mg/kg after completing pre-oxygenation.
direct IV injection
direct IV injection at dosage of 2 mg/kg (adjusted body weight if BMI \> 30) after completing pre-oxygenation
Interventions
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combination of Ketamine and Propofol
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.
direct IV injection
direct IV injection at dosage of 2 mg/kg (adjusted body weight if BMI \> 30) after completing pre-oxygenation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Locations
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Chr Angers
Angers, , France
CHRU de Brest Hôpital Cavale Blanche
Brest, , France
Ch Louis Pasteur
Chartres, , France
CHU Dijon
Dijon, , France
CHU Grenoble Alpes
Grenoble, , France
CHD Vendée
La Roche-sur-Yon, , France
APHP Bicêtre
Le Kremlin-Bicêtre, , France
CH Le Mans
Le Mans, , France
CHU Lille Hopital Salengro
Lille, , France
CHU Lille Hôpital Claude Huriez
Lille, , France
CHU Lyon Hôpital Sud
Lyon, , France
HCL Lyon Croix-Rousse
Lyon, , France
Chu Nantes (Laennec)
Nantes, , France
Chu Nantes
Nantes, , France
APHP St-Antoine
Paris, , France
APHP Tenon
Paris, , France
CHU Poitiers
Poitiers, , France
Hopital Foch
Suresnes, , France
CHU Toulouse Hôpital Purpan
Toulouse, , France
CHU Toulouse Hôpital Rangueil
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Nidhal CHEBBI
Role: primary
Morgan LE GUEN
Role: primary
Other Identifiers
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RC24_0389
Identifier Type: -
Identifier Source: org_study_id
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