Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-02-23 @ 2:14 AM
Study NCT ID:
NCT06566469
Status:
COMPLETED
Last Update Posted:
2025-07-31
First Post:
2024-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine-esketamine Combined Nasal Administration and Emergence Delirium
Sponsor:
Organization:
Raw JSON
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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'}, {'measure': 'Incidence of postoperative complications within 30 days after surgery', 'timeFrame': 'Up to 30 days after surgery', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Incidence of emergence delirium after surgery', 'timeFrame': 'During stay in the post-anesthesia care unit', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Incidence of emergence agitation', 'timeFrame': 'During anesthesia emergence in the operating room', 'description': '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.'}, {'measure': 'Subjective sleep quality score', 'timeFrame': 'The night before surgery and the night of surgery', 'description': '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.'}, {'measure': 'Incidence of delayed neurocognitive recovery', 'timeFrame': 'At 5 days after surgery', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Older patients', 'Nasal administration', 'Dexmedetomidine', 'Esketamine', 'General anesthesia', 'Emergence delirium'], 'conditions': ['Older Patients', 'Nasal Administration', 'Dexmedetomidine', 'Esketamine', 'General Anesthesia', 'Emergence Delirium']}, 'referencesModule': {'references': [{'pmid': '22669559', 'type': 'BACKGROUND', 'citation': 'Marcantonio ER. Postoperative delirium: a 76-year-old woman with delirium following surgery. JAMA. 2012 Jul 4;308(1):73-81. doi: 10.1001/jama.2012.6857.'}, {'pmid': '17325520', 'type': 'BACKGROUND', 'citation': 'Silverstein JH, Timberger M, Reich DL, Uysal S. Central nervous system dysfunction after noncardiac surgery and anesthesia in the elderly. 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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.', 'detailedDescription': 'Delirium is a common brain dysfunction syndrome in older patients after major surgery. Delirium that occurs after surgery includes emergence delirium and postoperative delirium. Emergence delirium occurred in 17.5% to 37.0% of patients following general anesthesia. The reported incidence of postoperative delirium ranged from 12.0% to 32.9% in older patients after noncardiac surgery. It is well known that the occurrence of postoperative delirium is associated with adverse outcomes. Recent studies found that emergence delirium is also associated with adverse perioperative outcomes, including increased postoperative delirium, more non-delirium complications, longer hospital stay, and higher healthcare costs.\n\nDexmedetomidine is a highly selective alpha 2-adrenoceptor agonist with sedative, anxiolytic, and analgesic effects. Prophylactic administration of dexmedetomidine preoperatively or intraoperatively has also been shown to reduce the incidence of postoperative delirium. Dexmedetomidine via nasal administration is now widely used for pediatric preoperative sedation. Nasal administration of dexmedetomidine is also used in adults. In a retrospective study, postoperative nasal administration of dexmedetomidine (100 μg) to elderly orthopedic surgical patients improved analgesia and reduced symptoms of agitation. A recent study of patients undergoing gynecologic laparoscopic surgery, night-time dexmedetomidine (1.5 µg/kg) administration by nasal drops from preoperative day 1 to postoperative day 5 improved sleep quality and reduced the incidence of postoperative delirium.\n\nEsketamine is a N-methyl-D-aspartic acid receptor antagonist and has been used as an anesthetic and analgesic. Low-dose intravenous infusion of ketamine is recommended for postoperative analgesia. Esketamine is s-enantiomer of ketamine and twice as potent as ketamine in analgesic potency. Nasal administration of esketamine is approved by FDA for intractable depression in adults. A randomized trial showed that nasal application of esketamine was effective in relieving post-thoracic puncture pain in adult patients without significant adverse effects. And postoperative pain is a common risk factor of emergence delirium and postoperative delirium.\n\nThis randomized trial is designed to test the hypothesis that combined nasal administration of dexmedetomidine-esketamine combination may reduce the incidence of emergence delirium in older patients after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Aged ≥ 65 years;\n2. Scheduled for inpatient elective or semi-elective surgery under general anesthesia, with an expected surgical duration of ≤2 hours;\n3. Planned to stay in hospital for at least 1 day after surgery.\n\nExclusion Criteria:\n\n1. Not suitable for intranasal drug administration due to nasal disease (e.g., rhinitis, nasal polyps, or nasal congestion due to any cause);\n2. Preoperative schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or delirium;\n3. Inability to communicate due to coma, severe dementia, or language barrier before surgery;\n4. Brain trauma or neurosurgery;\n5. Use of sedatives or hypnotics at bedtime during the last month;\n6. History of hyperthyroidism or pheochromocytoma;\n7. 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;\n8. Severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (receiving dialysis before surgery), or American Society of Anesthesiologists classification ≥ IV;\n9. Planned admission to the intensive care unit after surgery;\n10. Allergic to dexmedetomidine and/or esketamine, or any other conditions that are considered unsuitable for study participation."}, 'identificationModule': {'nctId': 'NCT06566469', 'briefTitle': 'Dexmedetomidine-esketamine Combined Nasal Administration and Emergence Delirium', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': 'Effect of Dexmedetomidine-esketamine Combined Nasal Administration on Emergence Delirium in Elderly Patients After Surgery: a Randomized, Double-blind, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': '2024-405'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combined dexmedetomidine-esketamine', 'description': '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.', 'interventionNames': ['Drug: Dexmedetomidine', 'Drug: Esketamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal saline', 'description': '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.', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Dexmedetomidine 0.5 µg/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.', 'armGroupLabels': ['Combined dexmedetomidine-esketamine']}, {'name': 'Esketamine', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Combined dexmedetomidine-esketamine']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Dong-Xin Wang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University First Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University First Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and chairman, Department of Anesthesiology', 'investigatorFullName': 'Dong-Xin Wang', 'investigatorAffiliation': 'Peking University First Hospital'}}}}