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NCT Number: NCT06750939

The Impact of Propofol and Ketamine on Cardiovascular Collapse During Induction for Intubation

This prospective observational study evaluates the impact of propofol and ketamine on the risk of cardiovascular collapse during induction for endotracheal intubation in critically ill patients. Induction agents play a crucial role in managing hemodynamic stability, particularly in this vulnerable population. Propofol, known for its vasodilatory and myocardial depressant effects, has been associated with significant hypotension during induction. Conversely, ketamine, with its sympathomimetic properties, is often considered a safer alternative for hemodynamic stability.

In addition to comparing the incidence of cardiovascular collapse-defined as severe hypotension or cardiac arrest-this study examines the relationship between these induction agents and shock indices, including systolic shock index, diastolic shock index, age-adjusted shock index, and modified shock index. These parameters will provide a more detailed understanding of the hemodynamic effects of each agent and their clinical implications. The findings aim to guide induction agent selection to optimize outcomes in critically ill patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kocaeli City Hospital

Köseköy, Kocaeli, 41060, Turkey (Türkiye)

Location status: Recruiting

Location contact

+90 262 225 27 00 3853 Kocaeli City Hospital

CONTACT

[email protected]

+90-262-225-27-00

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged over 18 years
  • Patients admitted to the intensive care unit (ICU) who undergo endotracheal intubation during their ICU stay will be included.

Exclusion criteria

  • Patients who did not provide consent to participate in the study
  • Patients intubated due to cardiac arrest
  • Patients intubated outside the intensive care unit

Treatment and study plan

Propofol

Other

The hemodynamic effects of propofol and ketamine are well-documented in the general patient population, yet the incidence and characteristics of cardiovascular collapse induced by these agents in critically ill patients remain underexplored. Cardiovascular collapse, a severe and potentially life-threatening event, may arise due to the unique physiological stressors present in the critical care setting, including pre-existing hemodynamic instability, comorbidities, and the administration of high-risk pharmacological agents. Despite the theoretical understanding of these drugs' pharmacodynamics, there is limited evidence assessing their differential impact on cardiovascular function in this vulnerable population.

This study aims to contribute novel insights to the literature by exploring the association between these widely used sedative-hypnotic agents and the development of cardiovascular collapse. While propofol is known for its potent vasodilatory and myocardial depressive effects,

Ketamine

Other

The hemodynamic effects of propofol and ketamine are well-documented in the general patient population, yet the incidence and characteristics of cardiovascular collapse induced by these agents in critically ill patients remain underexplored. Cardiovascular collapse, a severe and potentially life-threatening event, may arise due to the unique physiological stressors present in the critical care setting, including pre-existing hemodynamic instability, comorbidities, and the administration of high-risk pharmacological agents. Despite the theoretical understanding of these drugs' pharmacodynamics, there is limited evidence assessing their differential impact on cardiovascular function in this vulnerable population.

This study aims to contribute novel insights to the literature by exploring the association between these widely used sedative-hypnotic agents and the development of cardiovascular collapse. While propofol is known for its potent vasodilatory and myocardial depressive effects,

Primary outcomes

  1. cardiovascular collapse

    Time frame: The occurrence of any of the above-mentioned events within the first 30 minutes following the initiation of the intervention will be considered as cardiovascular collapse.

    • At least one documented episode of SpO₂ < 80%, ensuring accuracy of measurement.
    • At least one episode of systolic arterial blood pressure (SAB) < 65 mmHg.
    • SAB < 90 mmHg sustained for a duration of 30 minutes.
    • Initiation of norepinephrine therapy.
    • Escalation of pre-existing norepinephrine infusion dose.
    • Administration of >15 mL/kg crystalloid fluids to achieve SAB > 90 mmHg.
    • Occurrence of cardiac arrest.

Study contacts

Contact information is provided by the study sponsor or research team.

Ömer Emgin, MD

CONTACT

[email protected]

+90 262 225 27 00

Sponsors and collaborators

Lead sponsor

Kocaeli City Hospital

Other Gov

Registry information

Official study title

The Impact of Propofol and Ketamine on Cardiovascular Collapse During Induction for Endotracheal Intubation in Critically Ill Patients: A Prospective Observational Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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