Rapid Sequence Induction
Conditions
Keywords
Rapid sequence induction, Full stomach patient, hypotension, propofol, ketamine, ketofol, general anesthesia
Brief summary
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.
Interventions
DRUGdirect IV injection
direct IV injection at dosage of 2 mg/kg (adjusted body weight if BMI \> 30) after completing pre-oxygenation
DRUGcombination 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.
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 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
* 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: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| proportion of patients with successful intubation at first attempt and without post-induction hypotension | within 10 minutes after the start of the hypnotic injection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rates of tracheal intubation at the first attempt | within 10 minutes after the start of the hypnotic injection | rates of tracheal intubation at the first attempt compared between the three study groups |
| quality of the intubation | within 10 minutes after the start of the hypnotic injection | In the operating theatre (within 10 minutes after the start of the hypnotic injection): intubation difficulty scale (IDS-3) values |
| 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 | 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) |
| volume of intravenous fluids for vascular filling | up to relapse of the recovery room (up to 7 days after surgery) | volume of intravenous fluids for vascular filling (from entry into the operating theatre to induction and from induction to recovery room) |
| time between administration of hypnotic and tracheal intubation | within 10 minutes after the start of the hypnotic injection | 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) |
| rates of arterial hypotension episodes | within 10 minutes after the start of the hypnotic injection | rates of arterial hypotension episodes as defined in primary endpoint within 10 minutes after induction of anaesthesia compared between the three study groups |
| values of SpO2 | within 10 minutes after the start of the hypnotic injection | 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 |
| values of blood pressure | within 10 minutes after the start of the hypnotic injection | 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 |
| rates of pulmonary aspiration of gastric contents | within 10 minutes after the start of the hypnotic injection | 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 |
| Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol | during stay in the recovery room | 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 |
| values of heart rate | within 10 minutes after the start of the hypnotic injection | 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 |
Countries
France
Contacts
Primary ContactNicolas GRILLOT, MD
Outcome results
None listed