Propofol or Esketamine: Tracheal Intubation Comparison
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
Critically ill patient receiving care in the participating intensive care unit (ICU) and requiring emergency tracheal intubation using a rapid sequence intubation technique, as determined by the treating clinician.
Written informed consent provided by the participant or a legally authorized representative. Deferred consent is permitted under the protocol when the participant cannot provide consent because of critical illness, a legally authorized representative cannot be reached in time, and delaying intubation could cause irreversible harm. In these circumstances, written informed consent must be obtained as soon as possible and no later than 72 hours after intubation.
Disqualifiers
Emergency tracheal intubation during cardiac arrest.
Known or suspected elevated intracranial pressure.
Severe bradycardia, defined as a heart rate below 50 beats per minute.
Known allergy to esketamine or propofol.
Trial design
Design model
Parallel
Treatments tested in this trial
Esketamine
DrugEsketamine - 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
DrugPropofol - 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.
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: Propofol GroupActive comparator 1 intervention
Group B: Esketamine GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov
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