At a glance
ClinicalIndex Comparison Record- ✓Age 18-80 years old
- ✓Female and male patients
- ✓At least 1 risk factor for aspiration of gastric contents
- ✓Preoperative fasting period less than 6 hours
- ✕Predicted impossible tracheal intubation based on airway assessment criteria
- ✕Preoperative arterial hypotension (MAP < 65 mmHg or under catecholamine)
- ✕Preoperative respiratory distress syndrome (SpO2 < 90% in room air)
- ✕Allergy to ketamine, propofol, NMB, soy, or peanuts
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Best Hypnotic Drug Choice for Rapid Sequence Induction in the Operating Room: a 3-arm Randomized Trial
In Brief
A Phase 3 clinical trial evaluating direct IV injection and combination of Ketamine and Propofol for Rapid Sequence Induction. Currently recruiting, targeting 1,218 participants across 20 sites.
Detailed 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.
Study Details
Timeline
Interventions
direct IV injection at dosage of 2 mg/kg (adjusted body weight if BMI \> 30) after completing pre-oxygenation
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.