Dexmedetomidine-esketamine Combined Nasal Administration and Emergence Delirium
NCT Number: NCT06566469
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Older Patients|Nasal Administration|Dexmedetomidine|Esketamine|General Anesthesia|Emergence Delirium
Interventions: DRUG: Dexmedetomidine|DRUG: Esketamine|DRUG: Normal saline
Sponsor: Peking University First Hospital
Sex: ALL
Age: OLDER_ADULT
Enrollment: 340
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2026-09
Locations: Peking University First Hospital, Beijing, Beijing, 100034, China

Summary:
Emergence delirium is common in older patients after surgery and associated with worse perioperative outcomes, including increased postoperative delirium. Nasal administrations of both dexmedetomidine and esketamine are approved for medical purposes. Combination of low-dose dexmedetomidine and esketamine has shown some synergic effects in analgesia and anxiolysis. In a recent randomized trial, combined nasal administration of dexmedetomidine and esketamine was more effective in reducing pre-dental anxiety in pediatric patients. The investigators hypothesize that perioperative nasal administration of dexmedetomidine-esketamine combination can reduce the incidence of emergence delirium in older patients after surgery.

Primary Outcome Measures: Incidence of emergence delirium after surgery, Emergence delirium is assessed with the Richmond Agitation Sedation Scale (RASS; scores range from -5 \[unarousable\] to +4 \[combative\] and 0 indicates alert and calm) and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) at 5 and 30 minutes after admission to the post-anesthesia care unit., During stay in the post-anesthesia care unit
Secondary Outcome Measures: Incidence of emergence agitation, Emergence agitation is assessed with the RASS after surgery from cessation of general anesthesia to leaving operating room. A RASS score ≥+2 at any time is defined as having emergence agitation., During anesthesia emergence in the operating room|Subjective sleep quality score, Subjective sleep quality is assessed with the Richards-Campbell Sleep Questionnaire (RCSQ). The RCSQ is a self-reported measure that evaluates perception of nighttime sleep in five items, including sleep depth, sleep latency, number of awakenings, returning to sleep, and overall sleep quality. Each item is assessed with a 100 millimeter visual analog scale (score ranges from 0 to 100, with higher scores indicating better sleep quality). The mean score of the five items represents the overall sleep quality., The night before surgery and the night of surgery|Incidence of delayed neurocognitive recovery, Cognition is assessed with the telephone-Montreal Cognitive Assessment (T-MoCA; score ranges from 0 to 22, with higher score indicating better function). A reducation of T-MoCA score of ≥1 standard deviation (SD) from baseline is defined as having delayed neurocognitive recovery., At 5 days after surgery
Other Outcome Measures: Pain intensity within 24 hours after surgery, Pain intensity is assessed with the numeric rating scale (NRS, an 11-point scale where 0=no pain and 10=the worst pain) at 5 and 30 minutes on the day of surgery and between 8 and 10 am and 18 and 20 pm on the first day after surgery., Up to 24 hours after surgery|Analgesic use within 24 hours after surgery, Includes opioids and non-opioid analgesics., Up to 24 hours after surgery|Incidence of postoperative delirium within 3 days after surgery, Postoperative delirium is assessed twice daily (8-10 am and 18-20 pm) with the 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) for non-intubated patients or the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) for intubated patients., Up to 3 days after surgery|Length of hospital stay after surgery, Length of hospital stay after surgery., Up to 30 days after surgery|Subjective sleep quality at 30 day after surgery, Subjective sleep quality at 30 days is assessed with the Pittsburgh Sleep Quality Index (PSQI). PSQI is a 7-item questionnaire consisting 19 self-rated questions that assesses sleep quality over the last month, each weighted equally on a 0-3 scale; higher scores indicate worse sleep quality, At 30 days after surgery|Incidence of postoperative complications within 30 days after surgery, Postoperative complications are defined as new-onset medical events that are deemed harmful and required therapeutic intervention, that is grade II or higher on the Clavien-Dindo classification., Up to 30 days after surgery