MInimizing Delirium With Nasal Dexmedetomidine-InducEd Sleep (MIDDIES)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexmedetomidine, Placebo.
- Who it may be relevant to
- Registry conditions: Major Abdominal Surgery, Postoperative Delirium (POD), Sleep Disturbances, Intranasal Dexmedetomidine. Basic parameters: 65 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Minimizing Delirium With Nasal Dexmedetomidine-Induced Sleep in Older Patients Undergoing Major Abdominal Surgery: : a Randomized, Double-blind, Placebo-controlled Trial
Overview
This study aims to determine whether, compared with placebo, the nighttime self-administration of a nasal dexmedetomidine is effective at inducing sleep and preventing postoperative delirium in high-risk patients.
Detailed description
Delirium is an acute, short-term brain dysfunction characterized by fluctuating consciousness, cognitive decline, inattention, and sleep-wake cycle disruption. Postoperative delirium (POD), occurring predominantly within the first postoperative week (especially days 3-5 in elderly patients), affects 11-45% of older adults after major surgery. POD prolongs hospitalization, increases morbidity and mortality 5,65,6, yet its pathophysiology remains unclear, and evidence-based pharmacological prevention is lacking. Thus, effective POD prevention strategies are urgently needed.
Preoperative anxiety, a modifiable risk factor for POD, affects 11-80% of surgical patients. It contributes to sleep disturbances (e.g., insomnia, early awakening), which may exacerbate POD via neuroendocrine and immune dysregulation. However, benzodiazepines (e.g., lorazepam, diazepam, midazolam), though effective anxiolytics, increase delirium risk and are contraindicated preoperatively per current guidelines.
Dexmedetomidine (DEX), a selective α2-adrenoceptor agonist, induces physiological non-REM sleep without respiratory depression or hemodynamic instability. Its nasal formulation offers high bioavailability (82%), ease of administration, and is approved in China for preoperative sedation/anxiety. While intravenous (IV) DEX reduces POD in predominant ICU settings, its use in general wards remains unexplored. Preclinical studies suggest DEX enhances glymphatic clearance and exerts anti-inflammatory effects, potentially mitigating the development of POD. This study thus hypothesize that a nasal dexmedetomidine is effective at inducing sleep and preventing postoperative delirium in high-risk patient population. We set to demonstrate that to determine whether, compared with placebo, the nighttime self-administration of a nasal dexmedetomidine is effective at inducing sleep and preventing postoperative delirium in older patients undergoing major abdominal surgery.
Interventions
- Drug Dexmedetomidine
Intranasal dexmedetomidine (100 µg total: 4 sprays, 25 µg/spray; Hengrui Medicine, China) self-administered preoperatively (\~9 PM) and optionally on the night of surgery (patient decides dose: 0, 2 sprays, or 4 sprays). - Drug Placebo
Intranasal water for injection (4 sprays, identical volume as nasal dexmedetomidine; Hengrui Medicine, China) self-administered preoperatively (\~9 PM) and optionally on the night of surgery (patient decides dose: 0, 2 sprays, or 4 sprays).
Primary outcome measures
- Incidence of postoperative delirium [Time frame: Up to postoperative day (POD) 7 or discharge (whichever first).]
Secondary outcome measures (10)
- Delirium severity [Time frame: Up to postoperative day (POD) 7 or discharge (whichever first)]
- Physical activity [Time frame: Up to postoperative day (POD) 3]
- Sleep quality [Time frame: Up to postoperative day (POD) 3]
- Anxiety [Time frame: Up to postoperative day (POD) 3]
- Pain intensity [Time frame: Up to postoperative day (POD) 3]
- Opioid consumption [Time frame: Up to postoperative day (POD) 3]
- Health related quality of life [Time frame: On postoperative day (POD) 3 and 30]
- Quality of Recovery [Time frame: Up to postoperative day (POD) 3]
- Postoperative Nausea and Vomiting [Time frame: Up to postoperative day (POD) 3]
- Post-anesthesia Care Unit (PACU) length of stay [Time frame: Up to postoperative day (POD) 1]
Eligibility criteria
Inclusion criteria
- Aged 65-90 years
- Scheduled for a major abdominal surgery with estimated surgery time ≥ 2 hours
Exclusion criteria
- Blind, deafness or the inability to speak mandarin
- Allergy to dexmedetomidine.
- Renal and liver failure requiring dialysis or Child-Pugh score > 5
- Follow-up difficulties (i.e. active substance abuse, psychotic disorder, homelessness)
- Previous major abdominal or cardiac surgery within 1 year of surgical procedure
- Chronic therapy with benzodiazepines and/or antipsychotics. Severe deficit due to structural or anoxic brain damage
- Body weight < 35 kg
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07538284 · 2025ZSLYEC-227