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NOT YET RECRUITING
NCT07847255
PHASE4

Propofol or Esketamine: Tracheal Intubation Comparison

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

View on ClinicalTrials.gov

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.

Official title: Esketamine Versus Propofol for Rapid Sequence Intubation in Critically Ill Patients: A Prospective, Randomized, Open-Label, Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2026-10-08

Completion Date

2028-09-30

Last Updated

2026-09-29

Healthy Volunteers

No

Interventions

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.

DRUG

Propofol

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.

Locations (1)

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

Wuhan, China