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DEX-HIP Trial: Preoperative IV Dexamethasone 4 mg vs Placebo to Reduce Postoperative Delirium Burden in Adults ≥70 Undergoing Hip Fracture Surgery

DEX-HIP Trial: Preoperative IV Dexamethasone 4 mg vs Placebo to Reduce Postoperative Delirium Burden in Adults ≥70 Undergoing Hip Fracture Surgery : a Randomized Double-blind Trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07651150
Enrollment
120
Registered
2026-06-16
Start date
2026-01-01
Completion date
2026-04-15
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium - Postoperative, Hip Fracture Surgeries, Steroid

Brief summary

This single-center, prospective, randomized, double-blind, placebo-controlled trial was conducted at the Department of Orthopaedic Surgery, JPMC, Karachi. Patients aged ≥60 years with hip fractures were randomized 1:1 to receive either intravenous dexamethasone or a placebo preoperatively. The primary outcome was the incidence of POD within the first five postoperative days or until discharge, assessed via the Confusion Assessment Method. Delirium severity was quantified using the validated Memorial Delirium Assessment Scale.

Detailed description

Postoperative delirium (POD) is one of the most frequent and clinically significant complications following hip fracture surgery in older adults. It is associated with prolonged hospitalization, increased postoperative complications, delayed functional recovery, institutionalization, increased healthcare costs, and higher short- and long-term mortality. Despite advances in orthogeriatric care, POD remains highly prevalent among geriatric hip-fracture patients due to the combined effects of advanced age, frailty, baseline cognitive vulnerability, surgical stress, pain, inflammation, metabolic disturbance, and perioperative physiological insults. Emerging evidence suggests that neuroinflammation plays a central role in the pathophysiology of postoperative delirium. Hip fracture itself initiates a systemic inflammatory response that may be amplified by surgical intervention and postoperative stress. Corticosteroids such as dexamethasone possess potent anti-inflammatory properties and may attenuate inflammatory pathways implicated in delirium development. Previous studies, including the STRIDE feasibility trial and exploratory randomized trials in geriatric fracture populations, have suggested that preoperative dexamethasone may reduce delirium severity and possibly decrease delirium incidence following hip fracture surgery. However, evidence remains limited and inconsistent, and further randomized controlled trials are required to clarify the efficacy and safety of this intervention. This study was designed as a single-center, prospective, randomized, double-blind, placebo-controlled parallel-group clinical trial conducted at the Department of Orthopaedic Surgery, Jinnah Postgraduate Medical Centre (JPMC), Karachi, Pakistan. The study evaluated whether administration of a single low-dose preoperative intravenous dexamethasone injection (4 mg) could reduce the incidence and severity of postoperative delirium in older adults undergoing surgery for hip fracture. Eligible participants included adults aged 60 years or older with hip fractures less than three weeks old who were scheduled for operative management and were able to undergo postoperative delirium assessment. Participants were randomly assigned in a 1:1 ratio to receive either intravenous dexamethasone 4 mg or an equivalent volume of normal saline placebo before surgery. Randomization was computer-generated with concealed allocation. Study medications were prepared by personnel not involved in patient care or outcome assessment to maintain blinding of participants, treating clinicians, and outcome assessors. The primary outcome was the incidence of postoperative delirium within the first five postoperative days or until discharge, assessed using the Confusion Assessment Method (CAM/CAM-ICU). Delirium severity was evaluated using the validated Memorial Delirium Assessment Scale (MDAS). Secondary outcomes included length of hospital stay, postoperative complications, postoperative hyperglycaemia, infection, and readmission.

Interventions

DRUGDexamethasone

A single 4 mg intravenous dose administered preoperatively.

DRUGPlacebo

Participants received an equivalent volume of normal saline placebo preoperatively.

Sponsors

Jinnah Postgraduate Medical Centre
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults aged 60 years or older Hip fracture less than 3 weeks old Planned for operative management of hip fracture Able to undergo postoperative delirium assessment

Exclusion criteria

Systemic corticosteroid use within the previous 30 days Known hypersensitivity or contraindication to dexamethasone Active infection or sepsis Severe immunosuppression Uncontrolled diabetes mellitus Severe hepatic failure Inability to assess delirium reliably

Design outcomes

Primary

MeasureTime frameDescription
Incidence of postoperative deliriumTime Frame: Postoperative Day 1 through Postoperative Day 5, or until hospital discharge, whichever occurs firstProportion of participants with postoperative delirium, defined as a positive Confusion Assessment Method or Confusion Assessment Method for the Intensive Care Unit assessment on any postoperative day.Memorial Delirium Assessment Scale, 0 to 30, and higher scores indicate worse delirium severity.

Secondary

MeasureTime frameDescription
Delirium severityPostoperative Day 1 through Postoperative Day 5, or until hospital discharge, whichever occurs firstDelirium severity measured using the Memorial Delirium Assessment Scale. The Memorial Delirium Assessment Scale is scored from 0 to 30, with higher scores indicating greater delirium severity/worse outcome.
Length of hospital stayFrom date of surgery until date of hospital discharge, assessed up to 30 daysDuration of hospitalization after surgery, measured in days, from the date of surgery to the date of hospital discharge.
post operative hyperglycaemiaFrom study drug or placebo administration through hospital discharge, assessed up to 30 daysProportion of participants with postoperative hyperglycemia after study drug or placebo administration during the index hospitalization. Postoperative hyperglycemia is defined as at least one postoperative blood glucose value above the prespecified study threshold.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026