- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06750939
The Impact of Propofol and Ketamine on Cardiovascular Collapse During Induction for Intubation
The Impact of Propofol and Ketamine on Cardiovascular Collapse During Induction for Endotracheal Intubation in Critically Ill Patients: A Prospective Observational Study
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ömer Emgin, MD
- Phone Number: +90 262 225 27 00
- Email: omermgin@yahoo.com
Study Locations
-
-
Kocaeli
-
Köseköy, Kocaeli, Turkey (Türkiye), 41060
- Recruiting
- Kocaeli City Hospital
-
Contact:
- +90 262 225 27 00 3853 Kocaeli City Hospital
- Phone Number: +90-262-225-27-00
- Email: omeremgin@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cardiovascular collapse
"- At least one documented episode of SpO₂ < 80%, ensuring accuracy of measurement.
|
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, 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, |
|
No Cardiovascular collapse
|
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, 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, |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
|
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.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ksh.Oemgin.001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intubation Complication
-
Emory UniversityTerminatedAirway Morbidity | Intubation Complication | Anesthesia Intubation Complication | Tracheal Intubation Morbidity | Failed or Difficult Intubation, SequelaUnited States
-
University Hospital HeidelbergRecruitingIntubation | Intubation ComplicationGermany
-
National Cheng-Kung University HospitalNot yet recruitingIntubation; Complication | Intubation Intraesophageal | Intubation Depth | Intubation, Nasogastric | Intubation Times
-
Spanish Network for Research in Infectious DiseasesCompletedIntubation | Intubation Complication | Intubation; Difficult or FailedSpain
-
University at BuffaloTerminatedIntubation Complication | Intubation;DifficultUnited States
-
Heinrich-Heine University, DuesseldorfCompleted
-
Kaohsiung Medical University Chung-Ho Memorial...CompletedIntubation Complication | Intubation, DifficultTaiwan
-
Huazhong University of Science and TechnologyCompletedIntubation Complication | Intubation; DifficultChina
-
Hospital General Universitario de ValenciaFIPSERecruitingDifficult Intubation | Anesthesia Intubation ComplicationSpain
-
University Hospital, Clermont-FerrandSociété Française d'Anesthésie-Réanimation (SFAR)CompletedEndotracheal Intubation | Intubation Complication | Intubation; Difficult or FailedFrance
Clinical Trials on propofol
-
Nurdan SağbaşActive, not recruitingMajor Depression | Bipolar Affective Disorder | Bipolar Depression Depressed PhaseTurkey (Türkiye)
-
Groupe Hospitalier Diaconesses Croix Saint-SimonCompletedOocyte Retrieval | Medically Assisted Procreation (MAP)France
-
Hacettepe UniversityRecruitingSedation | Target Controlled Infusion of Propofol | Intensive Care Unit SedationTurkey (Türkiye)
-
Marmara University Pendik Training and Research...Not yet recruitingEndoscopic Submucosal Dissection | Respiratory Complications | Target Controlled Infusion of Propofol | Endoscopy Unit
-
Hopital FochCompleted
-
Stanford UniversityTiny Blue Dot FoundationEnrolling by invitationHealthy VolunteersUnited States
-
Istanbul University - CerrahpasaRecruitingAtrial Fibrillation | Deep Sedation | Electric CountershockTurkey (Türkiye)
-
University Medical Center GroningenCompletedAnesthesia | Hemodynamic Instability | Interaction | Disorder of Oxygen TransportNetherlands
-
Istanbul UniversityRecruitingTotal Intravenous Anesthesia | Spinal (Fusion) Surgery | Target Controlled Infusion of Propofol | BIS-EEG | Anesthesia Depth MonitoringTurkey (Türkiye)
-
Konkuk University Medical CenterCompletedCoronary Artery Disease | Valvular Heart DiseaseKorea, Republic of