Delirium - PostoperativePhase 2NCT07443085
Effect of Dexmedetomidine Dosage on Postoperative Delirium in Geriatric Orthopedic Surgery
A Phase 2 study testing Dexmedetomidine (Low dose), Dexmedetomidine (High dose) and Fentanyl in people with Delirium - Postoperative, run by Benha University at 1 site in Egypt.
Trial summary
This study evaluates the dose-response relationship of Dexmedetomidine (DEX) in reducing the incidence and severity of postoperative delirium (POD) and postoperative cognitive dysfunction (POCD) in elderly patients. Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Delirium - Postoperative
- What is being tested?
- Dexmedetomidine (Low dose), Dexmedetomidine (High dose) and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Feb 2026to 24 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elderly surgical patients.
- ASA physical status grade II-III.
- Planned major lower limb orthopedic surgery.
Who cannot join
- pre-existing dementia or drug allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose-Effect Relationship of Dexmedetomidine on Delirium and Cognitive Function After Lower Limb Orthopedic Surgeries for Elderly Patients
This study evaluates the dose-response relationship of Dexmedetomidine (DEX) in reducing the incidence and severity of postoperative delirium (POD) and postoperative cognitive dysfunction (POCD) in elderly patients. The study compares different doses of DEX against a fentanyl control group in patients undergoing major lower limb orthopedic surgery under general anesthesia to determine the optimal dosage for cognitive protection.
- Conditions
- Delirium - Postoperative
- Being tested
- Dexmedetomidine (Low dose), Dexmedetomidine (High dose), Fentanyl
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine (Low dose)Drug
Patients receive a specific low-dose intravenous infusion of Dexmedetomidine during major lower limb orthopedic surgery under opioid-based general anesthesia. The intervention aims to evaluate the dose-response relationship regarding its neuroprotective effects on postoperative delirium (POD).
Dexmedetomidine (High dose)Drug
Patients receive a higher-dose intravenous infusion of Dexmedetomidine during the surgical procedure. This arm is designed to determine if higher concentrations of DEX provide a more significant reduction in the incidence and severity of postoperative delirium and cognitive dysfunction compared to the lower dose.
FentanylDrug
Patients in this group receive standard opioid-based general anesthesia using fentanyl without the addition of Dexmedetomidine. This group serves as the baseline to compare the efficacy of DEX in preventing cognitive decline.
| Study group | Role | What they receive |
|---|---|---|
| DEX Group 1 (Low Dose) | Active comparator | Patients receive a specific low-dose intravenous infusion of Dexmedetomidine during major lower limb orthopedic surgery under opioid-based general anesthesia. The intervention aims to evaluate the dose-response relationship regarding its neuroprotective effects on postoperative delirium (POD). Receives: Drug: Dexmedetomidine (Low dose) |
| DEX Group 1 (High Dose) | Active comparator | Patients receive a higher-dose intravenous infusion of Dexmedetomidine during the surgical procedure. This arm is designed to determine if higher concentrations of DEX provide a more significant reduction in the incidence and severity of postoperative delirium and cognitive dysfunction compared to the lower dose. Receives: Drug: Dexmedetomidine (High dose) |
| Control Group | Active comparator | Patients in this group receive standard opioid-based general anesthesia using fentanyl without the addition of Dexmedetomidine. This group serves as the baseline to compare the efficacy of DEX in preventing cognitive decline. Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Delirium (POD)
The percentage of participants diagnosed with delirium within the first 48 hours after surgery. Diagnosis is defined by the Confusion Assessment Method (CAM) algorithm, requiring the presence of acute onset/fluctuating course and inattention, plus either disorganized thinking or altered level of consciousness.
Unit of Measure: Percentage of participants
Measured: 48 hours post-surgery
Secondary outcomes (2)
Severity of Postoperative Cognitive Dysfunction (POCD)
Assessment of cognitive decline using the Mini-Mental State Examination (MMSE) scores compared to baseline.
Unit: Score on a scale of 0 to 30
Measured: 1st and 4th weeks post-surgery
Postoperative Sedation Level
Evaluation of patient sedation levels using the Ramsey Sedation Score (RSS).
Unit: Scale Score (1-6)
Measured: 24 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start26 Feb 2026
- Primary completion1 Jul 2026
- Study completion24 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium - PostoperativeStudies of the same condition, open and under way.
- More trials run by Benha 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Shaboub, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443085
- Sponsor's protocol ID
- RC24/2/2026
- Status last verified
- Aug 2026
- First submitted
- 25 Feb 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Effect Relationship of Dexmedetomidine on Delirium and Cognitive Function After Lower Limb Orthopedic Surgeries for Elderly Patients
- ClinicalTrials.gov ID
- NCT07443085
- Acronym / sponsor ID
- RC24/2/2026
- Conditions
- Delirium - Postoperative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 24 Aug 2026 (actual)
- First posted
- 2 Mar 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 evaluates the dose-response relationship of Dexmedetomidine (DEX) in reducing the incidence and severity of postoperative delirium (POD) and postoperative cognitive dysfunction (POCD) in elderly patients. The study compares different doses of DEX against a fentanyl control group in patients undergoing major lower limb orthopedic surgery under general anesthesia to determine the optimal dosage for cognitive protection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DEX Group 1 (Low Dose) | Active comparator | Drug: Dexmedetomidine (Low dose)Patients receive a specific low-dose intravenous infusion of Dexmedetomidine during major lower limb orthopedic surgery under opioid-based general anesthesia. The intervention aims to evaluate the dose-response relationship regarding its neuroprotective effects on postoperative delirium (POD). |
| DEX Group 1 (High Dose) | Active comparator | Drug: Dexmedetomidine (High dose)Patients receive a higher-dose intravenous infusion of Dexmedetomidine during the surgical procedure. This arm is designed to determine if higher concentrations of DEX provide a more significant reduction in the incidence and severity of postoperative delirium and cognitive dysfunction compared to the lower dose. |
| Control Group | Active comparator | Drug: FentanylPatients in this group receive standard opioid-based general anesthesia using fentanyl without the addition of Dexmedetomidine. This group serves as the baseline to compare the efficacy of DEX in preventing cognitive decline. |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elderly surgical patients.
- ASA physical status grade II-III.
- Planned major lower limb orthopedic surgery.
Key exclusion criteria (1 listed)
- pre-existing dementia or drug allergies
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 |
|---|---|---|
| Dexmedetomidine (Low dose)Patients receive a specific low-dose intravenous infusion of Dexmedetomidine during major lower limb orthopedic surgery under opioid-based general anesthesia. The intervention aims to evaluate the dose-response relationship regarding its neuroprotective effects on postoperative delirium (POD). | Drug | DEX Group 1 (Low Dose) |
| Dexmedetomidine (High dose)Patients receive a higher-dose intravenous infusion of Dexmedetomidine during the surgical procedure. This arm is designed to determine if higher concentrations of DEX provide a more significant reduction in the incidence and severity of postoperative delirium and cognitive dysfunction compared to the lower dose. | Drug | DEX Group 1 (High Dose) |
| FentanylPatients in this group receive standard opioid-based general anesthesia using fentanyl without the addition of Dexmedetomidine. This group serves as the baseline to compare the efficacy of DEX in preventing cognitive decline. | Drug | Control Group |
Primary outcome
Incidence of Postoperative Delirium (POD)
Time frame: 48 hours post-surgery
The percentage of participants diagnosed with delirium within the first 48 hours after surgery. Diagnosis is defined by the Confusion Assessment Method (CAM) algorithm, requiring the presence of acute onset/fluctuating course and inattention, plus either disorganized thinking or altered level of consciousness. Unit of Measure: Percentage of participants
2 secondary outcomes
Severity of Postoperative Cognitive Dysfunction (POCD)
Time frame: 1st and 4th weeks post-surgery
Postoperative Sedation Level
Time frame: 24 hours post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexmedetomidine (Low dose), Dexmedetomidine (High dose) and Fentanyl in people with Delirium - Postoperative, run by Benha University at 1 site in Egypt.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Delirium (POD) (time frame: 48 hours post-surgery). 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 25 Aug 2026.