MInimizing Delirium With Nasal Dexmedetomidine-InducEd Sleep (MIDDIES) (MIDDIES)

April 12, 2026 updated by: Xiangcai Ruan, MD, PhD, Sixth Affiliated Hospital, Sun Yat-sen University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
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).
Experimental: Dexmedetomidine
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of postoperative delirium
Time Frame: Up to postoperative day (POD) 7 or discharge (whichever first).
Confusion Assessment Method
Up to postoperative day (POD) 7 or discharge (whichever first).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Delirium severity
Time Frame: Up to postoperative day (POD) 7 or discharge (whichever first)
Confusion Assessment Method Score
Up to postoperative day (POD) 7 or discharge (whichever first)
Physical activity
Time Frame: Up to postoperative day (POD) 3
Fitbit Flex2 tracker
Up to postoperative day (POD) 3
Sleep quality
Time Frame: Up to postoperative day (POD) 3
Fitbit Flex2 tracker and Athens Insomnia Scale
Up to postoperative day (POD) 3
Anxiety
Time Frame: Up to postoperative day (POD) 3
Hamilton Anxiety Scale
Up to postoperative day (POD) 3
Pain intensity
Time Frame: Up to postoperative day (POD) 3
Numerical Rating Scale
Up to postoperative day (POD) 3
Opioid consumption
Time Frame: Up to postoperative day (POD) 3
Intravenous morphine equivalents
Up to postoperative day (POD) 3
Health related quality of life
Time Frame: On postoperative day (POD) 3 and 30
Health related quality of life assessed with the SF-36 health survey
On postoperative day (POD) 3 and 30
Quality of Recovery
Time Frame: Up to postoperative day (POD) 3
The Quality of Recovery-15 questionnaire
Up to postoperative day (POD) 3
Postoperative Nausea and Vomiting
Time Frame: Up to postoperative day (POD) 3
Postoperative Nausea and Vomiting Scale
Up to postoperative day (POD) 3
Post-anesthesia Care Unit (PACU) length of stay
Time Frame: Up to postoperative day (POD) 1
Post-anesthesia Care Unit (PACU) length of stay
Up to postoperative day (POD) 1

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Optional intranasal administration on the night of surgery
Time Frame: At night of the surgery
Optional intranasal administration of the same spray (patient decides dose: 0, 2 sprays, or 4 sprays)
At night of the surgery
Length of Hospital Stay
Time Frame: From postoperative day 0 until date of hospital discharge (Up to 30 days)
Medical Record Review
From postoperative day 0 until date of hospital discharge (Up to 30 days)
Cognitive function
Time Frame: Up to postoperative day (POD) 30
Abbreviated Mental Test Score
Up to postoperative day (POD) 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025ZSLYEC-227

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Immediately

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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