Status:
ACTIVE_NOT_RECRUITING
The Effect of the Sedo-Analgesia Protocol Applied to Intensive Care Unit Patients on Patient Outcomes
Lead Sponsor:
Cukurova University
Collaborating Sponsors:
Scientific Research Projects Coordination Unit
Conditions:
Neurosurgical Surgery
Sedo-analgesia
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Neurosurgical interventions are a leading cause of death and disability in adults, and managing intracranial hypertension in the acute phase is a critical treatment process to prevent secondary brain ...
Detailed Description
The study is planned as a randomized controlled intervention study to evaluate the effect of the sedo-analgesia protocol applied to intensive care patients on patient outcomes.
Eligibility Criteria
Inclusion
- Over 18 years of age,
- Undergoing elective or emergency neurosurgical surgery and admitted to intensive care after surgery,
- Postoperative Glasgow Coma Score 9\>GCS \<13,
- Requiring mechanical ventilation for at least 24 hours,
- Having a RASS score ≥ -4,
- Are hemodynamically stable,
- Receiving intermittent sedation,
- Patients whose relatives consent to the study will be included in the sample criteria.
Exclusion
- Those with alcohol or substance abuse,
- Those with known hearing loss,
- Those diagnosed with brain death,
- Those requiring deep sedation, such as those requiring the administration of muscle relaxants, a body mass index (BMI) \> 30, or those with conditions that affect consciousness such as hypercapnia, hyperglycemia, or hypoglycemic coma, or those requiring deep sedation such as pulmonary hypertension,
- Those with cognitive impairment such as epilepsy surgery, Huntington's disease, or frontal lobe or cerebral cortex damage,
- Those with any disease that impairs thermoregulation, such as damage to the hypothalamus, which controls the sleep-wake cycle, or damage to the thalamus, which causes disorders such as impaired brain motor functions,
- Those with quadriplegia,
- Those with a serious pulmonary condition (Chronic Obstructive Pulmonary Disease (COPD), asthma, pneumonia, pulmonary embolism, etc.),
- Those with an allergy to opioids (e.g., fentanyl, remifentanil, sufentanil, morphine),
- Those with severe liver disease and renal dysfunction.
- Psychiatric history (schizophrenia, mania, delirium, cognitive impairment, mental retardation).
- Patients who develop brain damage or complications during the study (such as a GCS \< 9 drop, rebleeding, status epilepticus, convulsions, mental status disturbance/delirium, vomiting, tremor, myoclonus) will be excluded from the study.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT07148544
Start Date
July 1 2025
End Date
August 1 2026
Last Update
August 29 2025
Active Locations (1)
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1
TC Adana City Training and Research Hospital
Adana, Turkey (Türkiye)