NCT05464979

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

May 10, 2023

Status Verified

July 1, 2022

Enrollment Period

1.9 years

First QC Date

July 14, 2022

Last Update Submit

May 8, 2023

Conditions

Critically Ill Patients

Keywords

EsketamineTracheal intubationHemodynamics

Outcome Measures

Primary Outcomes (24)

  • Level of systolic blood pressure, diastolic blood pressure and mean arterial pressure

    Systolic blood pressure, diastolic blood pressure and mean arterial pressure

    5 minutes before induction

  • Level of systolic blood pressure, diastolic blood pressure and mean arterial pressure

    Systolic blood pressure, diastolic blood pressure and mean arterial pressure

    0 hour after induction

  • Level of systolic blood pressure, diastolic blood pressure and mean arterial pressure

    Systolic blood pressure, diastolic blood pressure and mean arterial pressure

    0 hour after intubation

  • Level of systolic blood pressure, diastolic blood pressure and mean arterial pressure

    Systolic blood pressure, diastolic blood pressure and mean arterial pressure

    1 minute after intubation

  • Level of systolic blood pressure, diastolic blood pressure and mean arterial pressure

    Systolic blood pressure, diastolic blood pressure and mean arterial pressure

    5 minutes after intubation

  • Level of systolic blood pressure, diastolic blood pressure and mean arterial pressure

    Systolic blood pressure, diastolic blood pressure and mean arterial pressure

    10 minutes after intubation

  • Level of systolic blood pressure, diastolic blood pressure and mean arterial pressure

    Systolic blood pressure, diastolic blood pressure and mean arterial pressure

    30 minutes after intubation

  • Level of systolic blood pressure, diastolic blood pressure and mean arterial pressure

    Systolic blood pressure, diastolic blood pressure and mean arterial pressure

    60 minutes after intubation

  • Level of heart rate and respiratory rate

    Heart rate and respiratory rate

    5 minutes before induction

  • Level of heart rate and respiratory rate

    Heart rate and respiratory rate

    0 hour after induction

  • Level of heart rate and respiratory rate

    Heart rate and respiratory rate

    0 hour after intubation

  • Level of heart rate and respiratory rate

    Heart rate and respiratory rate

    1 minute after intubation

  • Level of heart rate and respiratory rate

    Heart rate and respiratory rate

    5 minutes after intubation

  • Level of heart rate and respiratory rate

    Heart rate and respiratory rate

    10 minutes after intubation

  • Level of heart rate and respiratory rate

    Heart rate and respiratory rate

    30 minutes after intubation

  • Level of heart rate and respiratory rate

    Heart rate and respiratory rate

    60 minutes after intubation

  • Level of pulse oximetry

    Pulse oximetry

    5 minutes before induction

  • Level of pulse oximetry

    Pulse oximetry

    0 hour after induction

  • Level of pulse oximetry

    Pulse oximetry

    0 hour after intubation

  • Level of pulse oximetry

    Pulse oximetry

    1 minute after intubation

  • Level of pulse oximetry

    Pulse oximetry

    5 minutes after intubation

  • Level of pulse oximetry

    Pulse oximetry

    10 minutes after intubation

  • Level of pulse oximetry

    Pulse oximetry

    30 minutes after intubation

  • Level of pulse oximetry

    Pulse oximetry

    60 minutes after intubation

Secondary Outcomes (19)

  • Doses of epinephrine and norepinephrine

    At 1 hour after intubation

  • Doses of epinephrine and norepinephrine

    At 24 hours after intubation

  • Plasma cytokine levels

    On day 3 after intubation

  • Acute physiology and chronic health evaluation (APACHE) Ⅱ score

    0 hour after study inclusion

  • Acute physiology and chronic health evaluation (APACHE) Ⅱ score

    1 day after intubation

  • +14 more secondary outcomes

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, esketamine was continuously pumped at 0.3-1.5 mg/kg/h to maintain sedation. The Richmond Agitation Sedation Scale (RASS) was used to assess the sedation of patients every 1 hour and maintains a RASS score of -2 to 0.

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 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. The RASS score was assessed every 1 h and maintained at -2 to 0.

Drug: midazolam, fentanyl

Interventions

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
midazolam, fentanylDRUG

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-80 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:

  • Allergic to esketamine or midazolam;
  • Patients with cardiac arrest during intubation;
  • Patients with suspected increased intracranial pressure;
  • bradycardia (heart rate below 50 beats/min) or atrioventricular block;
  • Untreated or undertreated patients with hyperthyroidism;
  • Diseases that may affect immune-related indicators, including autoimmune diseases (rheumatoid arthritis and systemic lupus erythematosus, etc.), and malignant hematological tumours (leukaemia and lymphoma, etc.);
  • Received radiotherapy or chemotherapy or received immunosuppressive drug treatment within the past 30 days, or received more than 10 mg of prednisolone per day (or other hormones at the same dose) continuous treatment;
  • History of solid organ or bone marrow transplantation;
  • Chronic nephrosis;
  • Severe chronic liver disease (child-Pugh: Grade C);
  • alcohol or opioid dependence, mental illness, or severe cognitive impairment;
  • Pregnant or breastfeeding;
  • Patients and/or their family members refuse to participate in the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Wuhan, Hubei, 430022, China

RECRUITING

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: 39972022DERIVED

MeSH Terms

Interventions

EsketamineKetamineMidazolamFentanyl

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Jiancheng Zhang, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiancheng Zhang, MD, PhD

CONTACT

+8613554105815zhjcheng1@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
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 1, 2022

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

May 10, 2023

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

After publication, the data supporting the findings of this study can be provided by the corresponding author upon reasonable request. Participant data without names and identifiers can be provided by the corresponding author and the Wuhan Union Hospital after approval. The research team will provide an email address for communication purposes once approval is obtained regarding sharing the data with others. The proposal with detailed description of the study objectives and statistical analysis plan will be needed for evaluation of the purpose for the data request. Additional materials may also be required during the process of evaluation.

Shared Documents
STUDY PROTOCOL
Time Frame
Six months after publication.
Access Criteria
Upon reasonable request.

Locations

CN(1)