NCT06733129

Best Hypnotic Drug Choice for Rapid Sequence Induction in the Operating Room

Best Hypnotic Drug Choice for Rapid Sequence Induction in the Operating Room: a 3-arm Randomized Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,218 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rapid Sequence Induction

Interventions

Type	Name	Description
DRUG	direct IV injection	direct IV injection at dosage of 2 mg/kg (adjusted body weight if BMI \> 30) after completing pre-oxygenation
DRUG	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.

Timeline

• Start date: 2025-04-14
• Primary completion: 2027-04-14
• Completion: 2027-04-30
• First posted: 2024-12-13
• Last updated: 2025-12-02

Locations

20 sites across 1 country: France