Propofol or Esketamine: Tracheal Intubation Comparison

NCT07847255 | Not Yet Recruiting Phase 4

• 1 other identifier: zjc202611
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critically Ill Adults Requiring Emergency Tracheal Intubation in the Intensive Care Unit

Outcome Measures

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.

  From administration of the study induction drug through 10 minutes after administration.

Secondary Outcomes (11)

• Average Mean Arterial Pressure During the First Hour After Induction

  From administration of the study induction drug through 60 minutes after administration.

• Percentage of Participants With Cardiovascular Collapse

  From administration of the study induction drug through 2 minutes after tracheal intubation.

• Percentage of Participants With Severe Hypotension

  From administration of the study induction drug through 60 minutes after administration.

• Percentage of Participants With Severe Hypoxemia

  From administration of the study induction drug through 60 minutes after administration.

• Percentage of Participants With Cardiac Arrest

  From administration of the study induction drug through 60 minutes after administration.

Study Arms (2)

Propofol Group

ACTIVE COMPARATOR

Drug: Propofol

Esketamine Group

EXPERIMENTAL

Drug: Esketamine

Interventions

Propofol DRUG

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.

Propofol Group

Esketamine DRUG

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.

Esketamine Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Pregnancy or breastfeeding.
• Untreated or inadequately treated hyperthyroidism.
• Severe chronic liver disease, classified as Child-Pugh class C.
• Alcohol or opioid dependence.
• Psychiatric illness or severe cognitive impairment.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Location

MeSH Terms

Interventions

Esketamine; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jiancheng Zhang

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start (Estimated): October 8, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: September 29, 2026

Record last verified: 2026-09

Locations

CN (1)