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

June 10, 2026 updated by: Jinnah Postgraduate Medical Centre

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • JPMC Karachi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexamethasone
Participants received a single preoperative intravenous dose of dexamethasone 4 mg before operative management of hip fracture.
Drug: Dexamethasone
A single 4 mg intravenous dose administered preoperatively.
Placebo Comparator: placebo
Participants received an equivalent volume of normal saline placebo preoperatively.
Drug: Placebo
Participants received an equivalent volume of normal saline placebo preoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative delirium
Time Frame: Time Frame: Postoperative Day 1 through Postoperative Day 5, or until hospital discharge, whichever occurs first
Proportion 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.
Time Frame: Postoperative Day 1 through Postoperative Day 5, or until hospital discharge, whichever occurs first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delirium severity
Time Frame: Postoperative Day 1 through Postoperative Day 5, or until hospital discharge, whichever occurs first
Delirium 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.
Postoperative Day 1 through Postoperative Day 5, or until hospital discharge, whichever occurs first
Length of hospital stay
Time Frame: From date of surgery until date of hospital discharge, assessed up to 30 days
Duration of hospitalization after surgery, measured in days, from the date of surgery to the date of hospital discharge.
From date of surgery until date of hospital discharge, assessed up to 30 days
post operative hyperglycaemia
Time Frame: From study drug or placebo administration through hospital discharge, assessed up to 30 days
Proportion 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.
From study drug or placebo administration through hospital discharge, assessed up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinnah Postgraduate Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Actual)

March 30, 2026

Study Completion (Actual)

April 15, 2026

Study Registration Dates

First Submitted

June 4, 2026

First Submitted That Met QC Criteria

June 10, 2026

First Posted (Actual)

June 16, 2026

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No.F.2-81/2026-GENL/13/JPMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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