Major Abdominal SurgeryPhase 2/3MIDDIESNCT07538284
MInimizing Delirium With Nasal Dexmedetomidine-InducEd Sleep (MIDDIES)
A Phase 2/3 study testing Dexmedetomidine in people with Major Abdominal Surgery and Postoperative Delirium (POD), run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Major Abdominal Surgery, Postoperative Delirium (POD), Sleep Disturbances
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 30 Jun 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65-90 years
- Scheduled for a major abdominal surgery with estimated surgery time ≥ 2 hours
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Minimizing Delirium With Nasal Dexmedetomidine-Induced Sleep in Older Patients Undergoing Major Abdominal Surgery: : a Randomized, Double-blind, Placebo-controlled Trial
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.
Read the 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.
- Conditions
- Major Abdominal Surgery, Postoperative Delirium (POD), Sleep Disturbances, Intranasal Dexmedetomidine
- Being tested
- Dexmedetomidine, Placebo
- Keywords
- dexmedetomidine, intranasal administration
- Medical subject headings
- Emergence Delirium, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
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).
PlaceboDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Not described Receives: Drug: Dexmedetomidine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
Confusion Assessment Method
Measured: Up to postoperative day (POD) 7 or discharge (whichever first).
Secondary outcomes (10)
Delirium severity
Confusion Assessment Method Score
Measured: Up to postoperative day (POD) 7 or discharge (whichever first)
Physical activity
Fitbit Flex2 tracker
Measured: Up to postoperative day (POD) 3
Sleep quality
Fitbit Flex2 tracker and Athens Insomnia Scale
Measured: Up to postoperative day (POD) 3
Anxiety
Hamilton Anxiety Scale
Measured: Up to postoperative day (POD) 3
Pain intensity
Numerical Rating Scale
Measured: Up to postoperative day (POD) 3
Opioid consumption
Intravenous morphine equivalents
Measured: Up to postoperative day (POD) 3
Health related quality of life
Health related quality of life assessed with the SF-36 health survey
Measured: On postoperative day (POD) 3 and 30
Quality of Recovery
The Quality of Recovery-15 questionnaire
Measured: Up to postoperative day (POD) 3
Postoperative Nausea and Vomiting
Postoperative Nausea and Vomiting Scale
Measured: Up to postoperative day (POD) 3
Post-anesthesia Care Unit (PACU) length of stay
Post-anesthesia Care Unit (PACU) length of stay
Measured: Up to postoperative day (POD) 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangcai Ruan, MD, PhD, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538284
- Sponsor's protocol ID
- 2025ZSLYEC-227
- Acronym
- MIDDIES
- Status last verified
- Apr 2026
- First submitted
- 30 May 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data and a data dictionary will be made available upon reasonable request to researchers who provide a methodologically sound proposal and whose use of the data has been approved the study authors. Data will be made available immediately following publication, with no anticipated end date, to achieve the aims specified in the approved proposal. Proposals should be directed to ruanxc@mail.sysu.edu.cn.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimizing Delirium With Nasal Dexmedetomidine-Induced Sleep in Older Patients Undergoing Major Abdominal Surgery: : a Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07538284
- Acronym / sponsor ID
- MIDDIES / 2025ZSLYEC-227
- Conditions
- Major Abdominal Surgery, Postoperative Delirium (POD), Sleep Disturbances, Intranasal Dexmedetomidine
- Keywords
- dexmedetomidine, intranasal administration
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Aged 65-90 years
- Scheduled for a major abdominal surgery with estimated surgery time ≥ 2 hours
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineIntranasal 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 | Dexmedetomidine |
| PlaceboIntranasal 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). | Drug | Placebo |
Primary outcome
Incidence of postoperative delirium
Time frame: Up to postoperative day (POD) 7 or discharge (whichever first).
Confusion Assessment Method
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified data and a data dictionary will be made available upon reasonable request to researchers who provide a methodologically sound proposal and whose use of the data has been approved the study authors. Data will be made available immediately following publication, with no anticipated end date, to achieve the aims specified in the approved proposal. Proposals should be directed to ruanxc@mail.sysu.edu.cn.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine in people with Major Abdominal Surgery and Postoperative Delirium (POD), run by Sixth Affiliated Hospital, Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mentying Ding, MD. (+86-15170375679, 15170375679@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium (time frame: Up to postoperative day (POD) 7 or discharge (whichever first).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.