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

Study acronym: HYPNOTIKS
StatusRecruiting
PhasePhase 3
Started2025-04-14
View on ClinicalTrials.gov ↗

Amendment history

2025-11-24
Study Status, Contacts/Locations v4
Study sitesdetails revised at 7 of 20 sites
2025-07-01
Study Status, Outcome Measures, Eligibility, Contacts/Locations v3
Study sites18→20
Eligibility criteria+118 characters
[...] 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 [...]
Secondary endpoints13 to 15 entries
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 Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol
2025-04-22
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-03-10→2027-04-14
Completion date2027-04-10→2027-04-30
Start dateestimated 2025-03-10→confirmed 2025-04-14
Study sitesdetails revised at 18 of 18 sites
2024-12-17
Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measures, Contacts/Locations v1
Secondary endpoints14 to 13 entries
quality of the intubation rates of failurevasopressor of tracheal intubationuse values of arterialblood pressure
Study sitescontacts updated at 1 of 18 sites
2024-12-09
Original filing
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.
Trial Details
NCT Number NCT06733129
Lead Sponsor Nantes University Hospital
Conditions Rapid Sequence Induction
Enrollment 1,218 participants
Start Date 2025-04-14
Primary Completion 2027-04-14 (estimated)
Study Completion 2027-04-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-02