A Phase 2/3 interventional study of Dexmedetomidine and Hyperbaric Bupivacaine with Normal Saline in Postoperative Delirium and Hip Fractures, sponsored by Assiut University. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Assiut University · Phase 2/3, Interventional, and Prevention
Among 82 studies testing dexmedetomidine in Emergence Delirium — 31 open to participants now, 32 under way, 3 of them phase 3. Dexmedetomidine · Emergence Delirium.
Among the 82 studies testing dexmedetomidine in Emergence Delirium, this one is the 30th largest by planned enrollment, is one of 15 that started in 2026, is one of 5 in phase 2/3, reaches primary completion later than 27 of the 31 other live ones, and was the 80th registered.
751 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.
Browse Emergence Delirium studies →31 of the 82 studies testing dexmedetomidine in Emergence Delirium are open now, in 11 countries. Recruiting first, the newest first:
Pakistan Institute of Medical Sciences · Sites in Pakistan
Boston Children's Hospital · Sites in United States
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Sites in Turkey
Bach Mai Hospital · Sites in Vietnam
Kasr El Aini Hospital · Sites in Egypt
By country, each count listing its studies:
Dexmedetomidine: first FDA approval 1999 (PRECEDEX), first EMA approval 2011. What it is approved for, and how studies give it, is on its page →
Of the 143 Emergence Delirium studies recruiting now, 78 (55%) set no upper age limit and 45 (31%) stop at 75 or younger; 35 take children under 18; 25 take healthy volunteers.
This study: 65 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
82 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 11 · Phase 3 13 · Phase 4 31
First in 2006; this study’s year is marked. 15 started in 2026.
This study's planned enrollment of 130 is close to the median of 120 across 464 interventional studies indexed under Emergence Delirium.
Median enrollment 100 across the 82 interventional studies. Of the 37 that completed or were terminated, 10 (27%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 82 have an industry lead sponsor. The 10 most frequent:
Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
14 studies in Emergence Delirium by Assiut University: 8 open now, 8 under way, 3 of them phase 3. Of 4 finished, 0 (0%) have results posted.
Among the 14 studies in Emergence Delirium by Assiut University, this one is the 2nd largest by planned enrollment of the 13 interventional ones that give a count, is one of 5 that started in 2026, is one of 2 in phase 2/3, and was the 12th registered.
Assiut University’s Emergence Delirium studies by the year they started, since 2016.
13 of the studies testing dexmedetomidine in Emergence Delirium that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07538284Phase 3Sixth Affiliated Hospital, Sun Yat-sen UniversityMInimizing Delirium With Nasal Dexmedetomidine-InducEd Sleep (MIDDIES) | 2026-12-31 |
| NCT07810556Phase 3Assiut UniversityIntrathecal Dexmedetomidine and Postoperative Delirium in Elderly Hip Fracture Surgery | 2027-10 |
| NCT07519863Ain Shams UniversityThe Effect of Dormicum-Ketamine Versus Dexmedetomidine on Emergence Delirium During Deep Sedation in Paediatric Burn Patients | 2026-11 |
| NCT07799311Pakistan Institute of Medical SciencesComparing the Efficacy of Propofol and Dexmedetomidine in Prevention of Emergence Agitation After Sevoflurane Anesthesia in Children | 2026-11-28 |
| NCT07601698Sohag UniversityDexmedetomidine vs Propofol-lidocaine Mixture in Preventing the Post Operative Emergence Agitation Following Sevoflurane Anasthesia | 2026-11-30 |
Among the 82 studies testing dexmedetomidine in Emergence Delirium, from their registry updates:
Among Assiut University’s 14 in Emergence Delirium:
This tab as a report to print or save as PDF → With an account.
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Dexmedetomidine
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.
Drug: Hyperbaric Bupivacaine with Normal Saline
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.
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.
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.
Time frame: 48 hours
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmedetomidine