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

NCT07651150 | Completed

• 1 other identifier: No.F.2-81/2026-GENL/13/JPMC
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium - Postoperative; Hip Fracture Surgeries; Steroid

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative delirium

  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 Outcomes (3)

• Delirium severity

  Postoperative Day 1 through Postoperative Day 5, or until hospital discharge, whichever occurs first

• Length of hospital stay

  From date of surgery until date of hospital discharge, assessed up to 30 days

• post operative hyperglycaemia

  From study drug or placebo administration through hospital discharge, assessed up to 30 days

Study Arms (2)

Dexamethasone

EXPERIMENTAL

Participants received a single preoperative intravenous dose of dexamethasone 4 mg before operative management of hip fracture.

Drug: Dexamethasone

placebo

PLACEBO COMPARATOR

Participants received an equivalent volume of normal saline placebo preoperatively.

Drug: Placebo

Interventions

Dexamethasone DRUG

A single 4 mg intravenous dose administered preoperatively.

Dexamethasone

Placebo DRUG

Participants received an equivalent volume of normal saline placebo preoperatively.

placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jinnah Postgraduate Medical Centre: lead

Study Sites (1)

JPMC Karachi

Karachi, Sindh, Pakistan

Location

Related Publications (7)

• Smith TO, Cooper A, Peryer G, Griffiths R, Fox C, Cross J. Factors predicting incidence of post-operative delirium in older people following hip fracture surgery: a systematic review and meta-analysis. Int J Geriatr Psychiatry. 2017 Apr;32(4):386-396. doi: 10.1002/gps.4655. Epub 2017 Jan 17.

  PMID: 28093812 BACKGROUND

• Peng G, Guan Z, Hou Y, Gao J, Rao W, Yuan X, Guo J, Huang X, Zhong Z, Lin J. Depicting developing trend and core knowledge of hip fracture research: a bibliometric and visualised analysis. J Orthop Surg Res. 2021 Mar 4;16(1):174. doi: 10.1186/s13018-021-02292-x.

  PMID: 33663568 BACKGROUND

• Tarazona-Santabalbina FJ, Ojeda-Thies C, Figueroa Rodriguez J, Cassinello-Ogea C, Caeiro JR. Orthogeriatric Management: Improvements in Outcomes during Hospital Admission Due to Hip Fracture. Int J Environ Res Public Health. 2021 Mar 16;18(6):3049. doi: 10.3390/ijerph18063049.

  PMID: 33809573 BACKGROUND

• Kluger MT, Skarin M, Collier J, Rice DA, McNair PJ, Seow MY, Connolly MJ. Steroids to reduce the impact on delirium (STRIDE): a double-blind, randomised, placebo-controlled feasibility trial of pre-operative dexamethasone in people with hip fracture. Anaesthesia. 2021 Aug;76(8):1031-1041. doi: 10.1111/anae.15465. Epub 2021 Apr 25.

  PMID: 33899214 RESULT

• Huang JW, Yang YF, Gao XS, Xu ZH. A single preoperative low-dose dexamethasone may reduce the incidence and severity of postoperative delirium in the geriatric intertrochanteric fracture patients with internal fixation surgery: an exploratory analysis of a randomized, placebo-controlled trial. J Orthop Surg Res. 2023 Jun 19;18(1):441. doi: 10.1186/s13018-023-03930-2.

  PMID: 37337260 RESULT

• Yang P, Fan Y, Tang W. Correlation of intraoperative blood pressure variability and postoperative delirium in elderly hip fracture surgery. Sci Rep. 2025 Apr 29;15(1):15007. doi: 10.1038/s41598-025-00019-0.

  PMID: 40301442 RESULT

• Wang F, Hao X, Zhu Y. Effects of perioperative intravenous glucocorticoids on perioperative neurocognitive disorders in adults after surgery: A PRISMA-compliant meta-analysis of randomized controlled trials. Medicine (Baltimore). 2023 Aug 25;102(34):e34708. doi: 10.1097/MD.0000000000034708.

  PMID: 37653739 RESULT

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 16, 2026
• Study Start: January 1, 2026
• Primary Completion: March 30, 2026
• Study Completion: April 15, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

PA (1)