Dexmedetomidine-esketamine Combined Nasal Administration and Emergence Delirium

Phase 4

Not yet recruiting

• Conditions: Older Patients; Nasal Administration; Dexmedetomidine; Esketamine; General Anesthesia; Emergence Delirium

• Registration Number: NCT06566469
• Lead Sponsor: Peking University First Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-20
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of emergence delirium after surgery

Secondary Outcome Measures

Name	Time	Method
Incidence of emergence agitation;Subjective sleep quality score;Incidence of delayed neurocognitive recovery