Phase
Condition
N/ATreatment
direct IV injection
combination of Ketamine and Propofol
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion 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 12hours,
orthopaedic trauma within the last 12 hours,
medical history of symptomatic gastroesophageal reflux or hiatus, hernia orgastroparesis or dysautonomia or gastroesophageal surgery with sphincterdysfunction)
patient requiring orotracheal intubation during general anaesthesia in the operatingroom.
patient or his/her next of kin written informed consent or emergency procedure
Exclusion
Exclusion Criteria:
predicted impossible tracheal intubation (≥ 1 of the following criteria: patientwith known intubation complications, Mallampati score IV, Thyromental Distance ≤ 4.0cm, Mouth Opening < 3 cm, Sternomental Distance < 12.5 cm, significant modificationof the airway due to congenital, cancer, trauma or burning lesions (non-exhaustivelist)) [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:
allergy to the active substance or to one of the excipients or to soy orpeanuts,
porphyria
intracranial hypertension
uncontrolled arterial hypertension (systolic arterial pressure > 180 mmHg)
personal or family history of known malignant hyperthermia, congenital musculardystrophy, myasthenia, a known congenital deficit in plasmapseudocholinesterase
pregnancy or breast-feeding woman
patients under court protection or guardianship
absence of insurance covering health costs
Study Design
Connect with a study center
Chr Angers
Angers,
FranceSite Not Available
CHRU de Brest Hôpital Cavale Blanche
Brest,
FranceSite Not Available
CHU Dijon
Dijon,
FranceSite Not Available
CHU Grenoble Alpes
Grenoble,
FranceSite Not Available
CHD Vendée
La Roche-sur-Yon,
FranceSite Not Available
APHP Bicêtre
Le Kremlin-Bicêtre,
FranceSite Not Available
CH Le Mans
Le Mans,
FranceSite Not Available
CHU Lille Hopital Salengro
Lille,
FranceSite Not Available
CHU Lille Hôpital Claude Huriez
Lille,
FranceSite Not Available
CHU Lyon Hôpital Sud
Lyon,
FranceSite Not Available
HCL Lyon Croix-Rousse
Lyon,
FranceSite Not Available
Chu Nantes
Nantes, 44093
FranceActive - Recruiting
Chu Nantes (Laennec)
Nantes, 44093
FranceSite Not Available
APHP St-Antoine
Paris,
FranceSite Not Available
APHP Tenon
Paris,
FranceSite Not Available
CHU Poitiers
Poitiers,
FranceSite Not Available
CHU Toulouse Hôpital Purpan
Toulouse,
FranceSite Not Available
CHU Toulouse Hôpital Rangueil
Toulouse,
FranceSite Not Available
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