Esketamine Induction Intubation in ICU Patients.

NCT05464979 | Completed Early Phase 1 Results

• 1 other identifier: ZJC202203
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Intubation in the intensive care unit (ICU) is usually an emergency. Pathophysiological changes such as shock, respiratory failure, and metabolic acidosis in critically ill patients can significantly increase the incidence of adverse events during intubation. Studies have shown that esketamine has no significant effect on body metabolism, endocrine system, liver, kidney, intestinal function and coagulation function. In terms of drug metabolism, esketamine has high bioavailability, short half-life, faster and more comfortable recovery of patients, and not only has the advantage of providing stable hemodynamics during endotracheal intubation, but also counteracts the respiratory depression caused by opioids. In addition, esketamine has antidepressant and anti-inflammatory properties. The investigators also found that combined prophylactic and therapeutic use of esketamine could attenuate systemic inflammation and inflammatory multi-organ injury in mice after CLP-induced lethal sepsis. This project aims to study the clinical effect of esketamine induction intubation and conventional induction intubation in ICU patients.

Conditions

Critically Ill Patients

Keywords

Esketamine; Tracheal intubation; Hemodynamics

Outcome Measures

Primary Outcomes (3)

• Mean Arterial Pressure Before, During, and After Tracheal Intubation

  Mean arterial pressure was recorded before induction, during induction, during intubation, and at 1, 5, 10, 30, and 60 minutes after tracheal intubation.

  From 5 minutes before induction through 60 minutes after tracheal intubation.

• Heart Rate Before, During, and After Tracheal Intubation

  Heart rate was recorded before induction, during induction, during intubation, and at 1, 5, 10, 30, and 60 minutes after tracheal intubation.

  From 5 minutes before induction through 60 minutes after tracheal intubation.

• Peripheral Oxygen Saturation Before, During, and After Tracheal Intubation

  Peripheral oxygen saturation was recorded before induction, during induction, during intubation, and at 1, 5, 10, 30, and 60 minutes after tracheal intubation.

  From 5 minutes before induction through 60 minutes after tracheal intubation.

Secondary Outcomes (4)

• Norepinephrine Infusion Dose During Induction and Within 1 Hour After Intubation

  From induction through 1 hour after tracheal intubation.

• Duration of Invasive Ventilator Support

  From inclusion until discontinuation of invasive ventilator support.

• Length of Intensive Care Unit Stay

  From inclusion until discharge from the intensive care unit, assessed up to 28 days after inclusion.

• Number of Participants Who Died Within 28 Days After Inclusion

  Up to 28 days after inclusion.

Study Arms (2)

Esketamine intubation group

EXPERIMENTAL

Esketamine at 0.5-1.0 mg/kg BW and rocuronium bromide at 0.6 mg/kg BW was given intravenously for induction intubation. After the intubation was completed, sufentanil citrate (0.08-0.15 μg/kg/h) combined with remimazolam besylate (0.15-0.25 mg/kg/h) was administered intravenously to sustain a Critical-Care Pain Observation Tool (CPOT) score 0 and a Richmond Agitation and Sedation Scale (RASS) score between -3 and 0 following intubation.

Drug: Esketamine Hydrochloride 28 Mg in 0.2 mL NASAL SOLUTION [Spravato]

Conventional intubation group

PLACEBO COMPARATOR

Midazolam at 0.1mg/kg BW, fentanyl at 1ug/kg BW, rocuronium bromide at 0.6mg/kg BW was given intravenously for induction intubation; After the intubation was completed, sufentanil citrate (0.08-0.15 μg/kg/h) combined with remimazolam besylate (0.15-0.25 mg/kg/h) was administered intravenously to sustain a Critical-Care Pain Observation Tool (CPOT) score 0 and a Richmond Agitation and Sedation Scale (RASS) score between -3 and 0 following intubation.

Drug: midazolam, fentanyl

Interventions

midazolam, fentanyl DRUG

Midazolam at 0.1mg/kg BW, fentanyl at 1ug/kg BW, rocuronium bromide at 0.6mg/kg BW was given intravenously for induction intubation; After the intubation was completed, sufentanil at 0.1 μg/kg/h was administered for analgesia, and remazolam tosylate at an initial dose of 0.075 mg/kg/h was administered for sedation, and the dose of remazolam tosylate was adjusted according to the RASS score.

Conventional intubation group

Esketamine Hydrochloride 28 Mg in 0.2 mL NASAL SOLUTION [Spravato] DRUG

Esketamine at 0.5-1.0 mg/kg BW and rocuronium bromide at 0.6 mg/kg BW was given intravenously for induction intubation. After the intubation was completed, esketamine was continuously pumped at 0.3-1.5 mg/kg/h to maintain sedation.

Also known as: (S)-ketamine

Esketamine intubation group

Eligibility Criteria

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

You may qualify if:

• Patients aged ≥ 18 years old without restriction of gender, race, religion, creed or nationality;
• Patients and/or their family members know and agree to participate in the trial.

You may not qualify if:

• Age \<18 years,Allergy to esketamine or midazolam;
• Endotracheal tract required intubation without notsedative drugs, such as cardiac arrest、neurologic dysfunction or the need for awake intubation
• Patients with suspected elevated intracranial pressure;
• Bradycardia (heartrate (HR) less than 50 beats / min) or atrioventricular block；
• Untreated or undertreated hyperthyroid patients;
• Chronic kidney disease;
• Severe chronic liver disease (child-Pugh: Grade C);
• Alcohol or opioid dependence, mental illness, or severe cognitive impairment;
• Pregnancy or lactation;
• Lack of informed consent.

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, Hubei, 430022, China

Location

Related Publications (1)

• Zhang X, Zhao X, Xu J, Liu H, Yuan S, Zhang J. Efficacy and safety of esketamine for emergency endotracheal intubation in ICU patients: a double-blind, randomized controlled clinical trial. Sci Rep. 2025 Feb 19;15(1):6089. doi: 10.1038/s41598-025-91016-w.

  PMID: 39972022 DERIVED

MeSH Terms

Interventions

Esketamine; Ketamine; Midazolam; Fentanyl

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

First, the allocation was made visible to medical personnel. Second, we did not conduct a comprehensive evaluation of the possible influences of other facets of the medical intervention (e.g., anti-infective therapy, fluid management, nutritional support therapy, renal-replacement therapy) on the clinical outcomes after intubation during ICU and hospital stay. Third, there is significant variation in what is considered adequate ketamine dose for anaesthetic induction in critically ill patients.

Results Point of Contact

• Title: Jiancheng Zhang, Dr.
• Organization: Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

zhjcheng1@126.com

+8613554105815

Study Officials

• Jiancheng Zhang, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 19, 2022
• Study Start: August 27, 2022
• Primary Completion: May 31, 2023
• Study Completion: June 28, 2023
• Last Updated: July 21, 2026
• Results First Posted: July 21, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Six months after publication.
• Access Criteria: Upon reasonable request.

Locations

CN (1)