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NOT YET RECRUITING
NCT07810556
PHASE2/PHASE3

Intrathecal Dexmedetomidine and Postoperative Delirium in Elderly Hip Fracture Surgery

Sponsor: Assiut University

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2026-10

Completion Date

2027-11

Last Updated

2026-09-09

Healthy Volunteers

No

Interventions

DRUG

Dexmedetomidine

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.

DRUG

Hyperbaric Bupivacaine with Normal Saline

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.