A Phase 4 interventional study of Esketamine and Propofol in Critically Ill Adults Requiring Emergency Tracheal Intubation in the Intensive Care Unit, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Phase 4, Interventional, and Treatment
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.
Exclusion Criteria:
Drug: Propofol
Drug: Esketamine
Esketamine - Intervention Description Esketamine will be administered as an intravenous bolus at a dose of 0.5-1.0 mg/kg for induction during rapid sequence intubation. The dose will be individualized according to age and hemodynamic status: 0.5 mg/kg for participants aged 65 years or older or with shock, and 1.0 mg/kg for other participants. Participants will also receive rocuronium 0.6 mg/kg intravenously for neuromuscular blockade. Intubation, monitoring, and blood pressure support will follow a standardized ICU protocol.
Propofol - Intervention Description Propofol will be administered as an intravenous bolus at a dose of 1.5 mg/kg for induction during rapid sequence intubation. Participants will also receive rocuronium 0.6 mg/kg intravenously for neuromuscular blockade. Intubation, monitoring, and blood pressure support will follow the same standardized ICU protocol used in the esketamine group.
Lowest Mean Arterial Pressure Within 10 Minutes After Induction
The lowest mean arterial pressure (MAP), measured in mmHg, recorded during the first 10 minutes after administration of the study induction drug. Blood pressure will be monitored using an arterial catheter, and MAP values will be recorded every 1-2 minutes.
Time frame: From administration of the study induction drug through 10 minutes after administration.
Average Mean Arterial Pressure During the First Hour After Induction
The arithmetic mean of all recorded mean arterial pressure (MAP) values during the first hour after administration of the study induction drug. MAP will be measured using an arterial catheter and expressed in mmHg.
Time frame: From administration of the study induction drug through 60 minutes after administration.
Percentage of Participants With Cardiovascular Collapse
Percentage of participants requiring initiation of a vasopressor at a norepinephrine-equivalent dose greater than 0.1 micrograms/kg/min or an increase in an existing vasopressor dose of more than 0.1 micrograms/kg/min in norepinephrine equivalents during the assessment period.
Time frame: From administration of the study induction drug through 2 minutes after tracheal intubation.
Percentage of Participants With Severe Hypotension
Percentage of participants with mean arterial pressure below 65 mmHg lasting at least 5 consecutive minutes during the first hour after administration of the study induction drug. Measurements obtained during cardiac arrest will be excluded from this assessment.
Time frame: From administration of the study induction drug through 60 minutes after administration.
Percentage of Participants With Severe Hypoxemia
Percentage of participants with peripheral oxygen saturation (SpO2) below 80% lasting at least 30 consecutive seconds, measured by pulse oximetry.
Time frame: From administration of the study induction drug through 60 minutes after administration.
Percentage of Participants With Cardiac Arrest
Percentage of participants experiencing cardiac arrest requiring chest compressions or defibrillation during the first hour after administration of the study induction drug.
Time frame: From administration of the study induction drug through 60 minutes after administration.
Time to Successful Tracheal Intubation
Time in seconds from the start of study induction drug administration to confirmation of correct tracheal tube placement by auscultation and detection of exhaled carbon dioxide. The interval will be measured using a stopwatch.
Time frame: From the start of study induction drug administration until confirmation of successful tracheal intubation during the intubation procedure.
All-Cause Mortality Within 7 Days
Percentage of participants who die from any cause within 7 days after randomization. Vital status will be determined through medical record review or telephone follow-up.
Time frame: From randomization through Day 7.
All-Cause Mortality Within 28 Days
Percentage of participants who die from any cause within 28 days after randomization. Vital status will be determined through medical record review or telephone follow-up.
Time frame: From randomization through Day 28.
All-Cause Mortality During Hospitalization
Percentage of participants who die from any cause during the index hospitalization after randomization, within the maximum follow-up period of 60 days.
Time frame: From randomization until hospital discharge or death, whichever occurs first, up to 60 days.
Cumulative Vasopressor Dose During the First 24 Hours
Total amount of all vasopressors administered during the first 24 hours after randomization, converted to norepinephrine-equivalent doses and summed for each participant. Cumulative doses will be calculated from medication administration and infusion records.
Time frame: From randomization through 24 hours after randomization.
Duration of Invasive Mechanical Ventilation
Time in hours from tracheal intubation to the first successful liberation from invasive mechanical ventilation, determined from medical records.
Time frame: From tracheal intubation until first successful liberation from invasive mechanical ventilation, with observation ending at hospital discharge or death and a maximum follow-up of 60 days.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology