Postoperative DeliriumPhase 2/3NCT07810556
Intrathecal Dexmedetomidine and Postoperative Delirium in Elderly Hip Fracture Surgery
A Phase 2/3 study testing Dexmedetomidine and Hyperbaric Bupivacaine with Normal Saline in people with Postoperative Delirium and Hip Fractures, run by Assiut University.
Trial summary
Postoperative delirium (POD) is a common and serious complication in elderly patients undergoing surgical repair for hip fractures, often triggered by acute pain, surgical stress, neuroinflammation, and opioid consumption. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium, Hip Fractures
- What is being tested?
- Dexmedetomidine and Hyperbaric Bupivacaine with Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Elderly patients aged 65 years or older.
- American Society of Anesthesiologists (ASA) physical status I, II, or III.
- Patients scheduled for elective or emergency hip fracture surgeries (e.g., internal fixation, hemiarthroplasty, or total hip arthroplasty).
- Eligible for and scheduled to undergo the procedure under spinal anesthesia.
- Written informed consent provided by the patient or their legally authorized representative.
Who cannot join
- Patient or legal representative refusal to participate in the study or receive spinal anesthesia.
- Absolute contraindications to spinal anesthesia (e.g., coagulopathy, bleeding disorders, localized infection at the puncture site, or severe hypovolemia).
- Pre-existing cognitive or neurological impairment (diagnosed dementia, baseline Mini-Mental State Examination [MMSE] score < 24, history of recent stroke, severe psychiatric illness, or chronic use of sedatives/antidepressants).
- Cardiovascular contraindications (baseline bradycardia with heart rate < 50 beats/min, advanced second- or third-degree atrioventricular block, or severe baseline hypotension with mean arterial pressure < 65 mmHg).
- Severe end-stage organ failure (severe hepatic or renal impairment).
- Severe auditory or visual impairment hindering proper cognitive evaluation, or inability to communicate.
- Intraoperative failure of spinal anesthesia requiring conversion to general anesthesia, surgical duration exceeding 2 hours, or massive intraoperative blood loss/hemodynamic instability.
About this study
Official title: Effect of Intrathecal Dexmedetomidine as an Adjuvant to Hyperbaric Bupivacaine on the Incidence of Postoperative Delirium in Elderly Patients Undergoing Hip Fracture Surgeries Under Spinal Anesthesia
Postoperative delirium (POD) is a common and serious complication in elderly patients undergoing surgical repair for hip fractures, often triggered by acute pain, surgical stress, neuroinflammation, and opioid consumption. Although spinal anesthesia using bupivacaine is commonly performed, local anesthetics alone often require additional systemic rescue opioids for postoperative pain relief, which can further increase delirium risk. Dexmedetomidine is a selective alpha-2 adrenergic agonist that has demonstrated neuroprotective, anti-inflammatory, and opioid-sparing effects.
The purpose of this clinical trial is to evaluate whether adding intrathecal dexmedetomidine as an adjuvant to hyperbaric bupivacaine during spinal anesthesia reduces the incidence and severity of postoperative delirium compared to hyperbaric bupivacaine alone in geriatric patients undergoing hip fracture surgeries.
Read more
Participants will be randomly assigned to one of two groups:
- Dexmedetomidine Group: Receives hyperbaric bupivacaine 0.5% (10 mg) combined with 5 µg dexmedetomidine intrathecally.
- Control Group: Receives hyperbaric bupivacaine 0.5% (10 mg) combined with normal saline intrathecally.
The primary outcome is the incidence of postoperative delirium evaluated using the Confusion Assessment Method (CAM) twice daily during the first 48 hours following surgery. Secondary assessments include the duration and severity of delirium episodes, spinal block characteristics, hemodynamic stability, postoperative pain scores, rescue analgesic consumption, sedation levels, adverse events, and total hospital length of stay.
- Conditions
- Postoperative Delirium, Hip Fractures
- Being tested
- Dexmedetomidine, Hyperbaric Bupivacaine with Normal Saline
- Keywords
- Dexmedetomidine, Bupivacaine, Spinal Anesthesia, Intrathecal Adjuvant, Geriatric Anesthesia, Confusion Assessment Method
- Medical subject headings
- Emergence Delirium, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
A single intrathecal dose of 5 µg dexmedetomidine (diluted in normal saline to 0.5 mL) combined with hyperbaric bupivacaine 0.5% (10 mg, 2.0 mL), administered via lumbar puncture prior to surgery.
Hyperbaric Bupivacaine with Normal SalineDrug
A single intrathecal injection of hyperbaric bupivacaine 0.5% (10 mg, 2.0 mL) combined with 0.5 mL of 0.9% normal saline (placebo volume equivalent), administered via lumbar puncture prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group D: Dexmedetomidine Group | Experimental | Patients will receive an intrathecal injection consisting of hyperbaric bupivacaine 0.5% (10 mg, 2.0 mL) plus 5 µg dexmedetomidine (diluted in normal saline to 0.5 mL), yielding a total volume of 2.5 mL administered via lumbar puncture at the L3-L4 or L4-L5 interspace. Receives: Drug: Dexmedetomidine |
| Group C: Control Group | Active comparator | Patients will receive an intrathecal injection consisting of hyperbaric bupivacaine 0.5% (10 mg, 2.0 mL) plus 0.5 mL normal saline, yielding an identical total volume of 2.5 mL administered via lumbar puncture at the L3-L4 or L4-L5 interspace. Receives: Drug: Hyperbaric Bupivacaine with Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Delirium Assessed by the Confusion Assessment Method (CAM)
Incidence is defined as the presence of postoperative delirium, assessed using the Confusion Assessment Method (CAM). A participant is considered positive for delirium if they exhibit Feature 1 (acute onset and fluctuating course) and Feature 2 (inattention), plus either Feature 3 (disorganized thinking) or Feature 4 (altered level of consciousness). Assessments are conducted twice daily.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziad Ali Fikrey Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810556
- Sponsor's protocol ID
- IT Dexmedetomidine & Delirium
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 9 Sep 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intrathecal Dexmedetomidine as an Adjuvant to Hyperbaric Bupivacaine on the Incidence of Postoperative Delirium in Elderly Patients Undergoing Hip Fracture Surgeries Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT07810556
- Acronym / sponsor ID
- IT Dexmedetomidine & Delirium
- Conditions
- Postoperative Delirium, Hip Fractures
- Keywords
- Dexmedetomidine, Bupivacaine, Spinal Anesthesia, Intrathecal Adjuvant, Geriatric Anesthesia, Confusion Assessment Method
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 9 Sep 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.
Postoperative delirium (POD) is a common and serious complication in elderly patients undergoing surgical repair for hip fractures, often triggered by acute pain, surgical stress, neuroinflammation, and opioid consumption. Although spinal anesthesia using bupivacaine is commonly performed, local anesthetics alone often require additional systemic rescue opioids for postoperative pain relief, which can further increase delirium risk. Dexmedetomidine is a selective alpha-2 adrenergic agonist that has demonstrated neuroprotective, anti-inflammatory, and opioid-sparing effects.
The purpose of this clinical trial is to evaluate whether adding intrathecal dexmedetomidine as an adjuvant to hyperbaric bupivacaine during spinal anesthesia reduces the incidence and severity of postoperative delirium compared to hyperbaric bupivacaine alone in geriatric patients undergoing hip fracture surgeries.
Participants will be randomly assigned to one of two groups:
- Dexmedetomidine Group: Receives hyperbaric bupivacaine 0.5% (10 mg) combined with 5 µg dexmedetomidine intrathecally.
- Control Group: Receives hyperbaric bupivacaine 0.5% (10 mg) combined with normal saline intrathecally.
The primary outcome is the incidence of postoperative delirium evaluated using the Confusion Assessment Method (CAM) twice daily during the first 48 hours following surgery. Secondary assessments include the duration and severity of delirium episodes, spinal block characteristics, hemodynamic stability, postoperative pain scores, rescue analgesic consumption, sedation levels, adverse events, and total hospital length of stay.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D: Dexmedetomidine Group | Experimental | Drug: DexmedetomidinePatients will receive an intrathecal injection consisting of hyperbaric bupivacaine 0.5% (10 mg, 2.0 mL) plus 5 µg dexmedetomidine (diluted in normal saline to 0.5 mL), yielding a total volume of 2.5 mL administered via lumbar puncture at the L3-L4 or L4-L5 interspace. |
| Group C: Control Group | Active comparator | Drug: Hyperbaric Bupivacaine with Normal SalinePatients will receive an intrathecal injection consisting of hyperbaric bupivacaine 0.5% (10 mg, 2.0 mL) plus 0.5 mL normal saline, yielding an identical total volume of 2.5 mL administered via lumbar puncture at the L3-L4 or L4-L5 interspace. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Elderly patients aged 65 years or older.
- American Society of Anesthesiologists (ASA) physical status I, II, or III.
- Patients scheduled for elective or emergency hip fracture surgeries (e.g., internal fixation, hemiarthroplasty, or total hip arthroplasty).
- Eligible for and scheduled to undergo the procedure under spinal anesthesia.
- Written informed consent provided by the patient or their legally authorized representative.
Key exclusion criteria (7 listed)
- Patient or legal representative refusal to participate in the study or receive spinal anesthesia.
- Absolute contraindications to spinal anesthesia (e.g., coagulopathy, bleeding disorders, localized infection at the puncture site, or severe hypovolemia).
- Pre-existing cognitive or neurological impairment (diagnosed dementia, baseline Mini-Mental State Examination [MMSE] score < 24, history of recent stroke, severe psychiatric illness, or chronic use of sedatives/antidepressants).
- Cardiovascular contraindications (baseline bradycardia with heart rate < 50 beats/min, advanced second- or third-degree atrioventricular block, or severe baseline hypotension with mean arterial pressure < 65 mmHg).
- Severe end-stage organ failure (severe hepatic or renal impairment).
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 |
|---|---|---|
| DexmedetomidineA single intrathecal dose of 5 µg dexmedetomidine (diluted in normal saline to 0.5 mL) combined with hyperbaric bupivacaine 0.5% (10 mg, 2.0 mL), administered via lumbar puncture prior to surgery. | Drug | Group D: Dexmedetomidine Group |
| Hyperbaric Bupivacaine with Normal SalineA single intrathecal injection of hyperbaric bupivacaine 0.5% (10 mg, 2.0 mL) combined with 0.5 mL of 0.9% normal saline (placebo volume equivalent), administered via lumbar puncture prior to surgery. | Drug | Group C: Control Group |
Primary outcome
Incidence of Postoperative Delirium Assessed by the Confusion Assessment Method (CAM)
Time frame: 48 hours
Incidence is defined as the presence of postoperative delirium, assessed using the Confusion Assessment Method (CAM). A participant is considered positive for delirium if they exhibit Feature 1 (acute onset and fluctuating course) and Feature 2 (inattention), plus either Feature 3 (disorganized thinking) or Feature 4 (altered level of consciousness). Assessments are conducted twice daily.
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 9 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine and Hyperbaric Bupivacaine with Normal Saline in people with Postoperative Delirium and Hip Fractures, run by Assiut 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 5 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 9 Sep 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. 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?
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 Assessed by the Confusion Assessment Method (CAM) (time frame: 48 hours). 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 9 Sep 2026.