Dexmedetomidine-esketamine Combined Nasal Administration and Emergence Delirium

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Aug 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a combined nasal treatment using two medications, dexmedetomidine and esketamine, to see if it can help reduce a condition called emergence delirium in older patients after surgery. Emergence delirium is when patients become confused or agitated when waking up from anesthesia, and it can lead to more serious problems. The researchers believe that using this combination of medications before and during surgery might help older patients recover better and feel less anxious.

To participate in this study, you need to be at least 65 years old and scheduled for a surgery that lasts less than two hours, with a hospital stay of at least one day afterward. However, there are some health conditions that could prevent you from joining, such as certain nasal issues, severe heart or kidney problems, or a history of specific neurological conditions. If you qualify, you can expect to receive this nasal treatment before surgery and be monitored closely to see how it affects your recovery. The trial is currently not recruiting participants, but it aims to improve care for older patients undergoing surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged ≥ 65 years;
• • 2. Scheduled for inpatient elective or semi-elective surgery under general anesthesia, with an expected surgical duration of ≤2 hours;
• • 3. Planned to stay in hospital for at least 1 day after surgery.
• Exclusion Criteria:
• • 1. Not suitable for intranasal drug administration due to nasal disease (e.g., rhinitis, nasal polyps, or nasal congestion due to any cause);
• • 2. Preoperative schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or delirium;
• • 3. Inability to communicate due to coma, severe dementia, or language barrier before surgery;
• • 4. Brain trauma or neurosurgery;
• • 5. Use of sedatives or hypnotics at bedtime during the last month;
• • 6. History of hyperthyroidism or pheochromocytoma;
• • 7. Preoperative left ventricular ejection fraction \<30%, or sick sinus node syndrome, severe sinus bradycardia (heart rate \<50 beats per minute), or atrioventricular block of degree II or higher without pacemaker, or systolic blood pressure \<90 mmHg before enrollment;
• • 8. Severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (receiving dialysis before surgery), or American Society of Anesthesiologists classification ≥ IV;
• • 9. Planned admission to the intensive care unit after surgery;
• • 10. Allergic to dexmedetomidine and/or esketamine, or any other conditions that are considered unsuitable for study participation.