Dexmedetomidine-esketamine Combined Nasal Administration and Emergence Delirium
Key facts
- Who runs it
- Peking University First Hospital
- Where
- China1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 4
- People taking part
- 340 people enrolled
- Started
- 2 Sept 2024
- Ended
- 1 May 2025
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Dexmedetomidine
- Esketamine
- Normal saline
- Record updated
- 31 July 2025
Who can take part
- Age
- 65 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- Aged ≥ 65 years
- Scheduled for inpatient elective or semi-elective surgery under general anesthesia, with an expected surgical duration of ≤2 hours
- Planned to stay in hospital for at least 1 day after surgery
Who cannot take part
- Severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (receiving dialysis before surgery), or American Society of Anesthesiologists classification ≥ IV
- Planned admission to the intensive care unit after surgery
- Not suitable for intranasal drug administration due to nasal disease (e.g., rhinitis, nasal polyps, or nasal congestion due to any cause)
- Preoperative schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or delirium
- Inability to communicate due to coma, severe dementia, or language barrier before surgery
- History of hyperthyroidism or pheochromocytoma
- Allergic to dexmedetomidine and/or esketamine, or any other conditions that are considered unsuitable for study participation
- 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
- Brain trauma or neurosurgery
- Use of sedatives or hypnotics at bedtime during the last month
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Combined dexmedetomidine-esketamineTreatment being tested
A mixture of dexmedetomidine 0.5 µg/kg and esketamine 0.2 mg/kg is administered via nasal spray at 20:30 pm the day before surgery and at 07:30 am and 20:30 pm the day of surgery.
Treatment: Dexmedetomidine and Esketamine
- Normal salinePlacebo, for comparison
Placebo (normal saline) at the same volume is administered via nasal spray at 20:30 pm the day before surgery and at 07:30 am and 20:30 pm the day of surgery.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effect of Dexmedetomidine-esketamine Combined Nasal Administration on Emergence Delirium in Elderly Patients After Surgery: a Randomized, Double-blind, Placebo-controlled Trial
- Record updated
- 31 July 2025