Intrathecal Dexmedetomidine and Postoperative Delirium in Elderly Hip Fracture Surgery
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age65+
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Dexmedetomidine
DrugA 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 Saline
DrugA 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.
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: Group D: Dexmedetomidine GroupExperimental treatment 1 intervention
Group B: Group C: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 hoursLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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