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Propofol or Esketamine: Tracheal Intubation Comparison

Study acronym: POETIC
StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to compare how esketamine and propofol affect blood pressure in critically ill adults who need a breathing tube in an intensive care unit (ICU). Placing a breathing tube into the windpipe is called tracheal intubation. Medicines are given to make patients unconscious and relax their muscles so the tube can be placed quickly. This procedure is called rapid sequence intubation. Blood pressure can fall during this process. The main question is whether esketamine leads to a higher minimum blood pressure than propofol during the first 10 minutes after the study medicine is given. Researchers will measure mean arterial pressure, which is the average pressure in the arteries during one heartbeat. The study will also compare the need for medicines to support blood pressure, complications around tube placement, survival, time on a breathing machine, and length of ICU stay. The study will enroll 130 adults aged 18 years or older at one hospital in China. Participants will be assigned by chance, like flipping a coin, to receive either esketamine or propofol through a vein before tube placement. Each participant will have an equal chance of receiving either medicine. The treating team will know which medicine is given. Both groups will receive a muscle relaxant and follow the same standard procedures for tube placement and blood pressure support. The care team will closely monitor blood pressure, heart rate, and blood oxygen levels before and after tube placement. Researchers will record side effects, including high blood pressure, a fast heart rate, and confusion after the procedure. Participants will continue to receive usual ICU care and will be followed until hospital discharge or death, for up to 60 days.
Trial Details
NCT Number NCT07847255
Lead Sponsor Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions Critically Ill Adults Requiring Emergency Tracheal Intubation in the Intensive Care Unit
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov