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

NCT06750939 | Recruiting

• 1 other identifier: ksh.Oemgin.001
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Collapse; Intubation Complication; Anaesthetic Complication Cardiac

Keywords

cardiac arrest; intubation; shock index

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (2)

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." 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.

Other: propofol; Other: ketamine

No Cardiovascular collapse

Other: propofol; Other: ketamine

Interventions

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,

Cardiovascular collapse; No Cardiovascular collapse

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,

Cardiovascular collapse; No Cardiovascular collapse

Eligibility Criteria

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

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kocaeli City Hospital: lead

Study Sites (1)

Kocaeli City Hospital

Köseköy, Kocaeli, 41060, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Shock; Heart Arrest

Interventions

Propofol; Ketamine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic

Central Study Contacts

Ömer Emgin, MD

CONTACT

+90 262 225 27 00; omermgin@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 27, 2024
• Study Start: July 15, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)