Delirium - PostoperativeNCT07651150
DEX-HIP Trial: Preoperative IV Dexamethasone 4 mg vs Placebo to Reduce Postoperative Delirium Burden in Adults ≥70 Undergoing Hip Fracture Surgery
A study testing Dexamethasone in people with Delirium - Postoperative and Hip Fracture Surgeries, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Delirium - Postoperative, Hip Fracture Surgeries, Steroid
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2026to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Delirium - Postoperative, Hip Fracture Surgeries, Steroid
- Being tested
- Dexamethasone, Placebo
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
A single 4 mg intravenous dose administered preoperatively.
PlaceboDrug
Participants received an equivalent volume of normal saline placebo preoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Participants received a single preoperative intravenous dose of dexamethasone 4 mg before operative management of hip fracture. Receives: Drug: Dexamethasone |
| placebo | Placebo comparator | Participants received an equivalent volume of normal saline placebo preoperatively. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time Frame: Postoperative Day 1 through Postoperative Day 5, or until hospital discharge, whichever occurs first
Secondary outcomes (3)
Delirium severity
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.
Measured: Postoperative Day 1 through Postoperative Day 5, or until hospital discharge, whichever occurs first
Length of hospital stay
Duration of hospitalization after surgery, measured in days, from the date of surgery to the date of hospital discharge.
Measured: From date of surgery until date of hospital discharge, assessed up to 30 days
post operative hyperglycaemia
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.
Measured: From study drug or placebo administration through hospital discharge, assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Jan 2026
- Primary completion30 Mar 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Delirium - PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinnah Postgraduate Medical Centre
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651150
- Sponsor's protocol ID
- No.F.2-81/2026-GENL/13/JPMC
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28093812Peng 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.
PubMed 33663568Tarazona-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.
PubMed 33809573Kluger 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.
PubMed 33899214Huang 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.
PubMed 37337260Yang 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.
PubMed 40301442Wang 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.
PubMed 37653739
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07651150
- Acronym / sponsor ID
- No.F.2-81/2026-GENL/13/JPMC
- Conditions
- Delirium - Postoperative, Hip Fracture Surgeries, Steroid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Jinnah Postgraduate Medical CentreOther government
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: DexamethasoneParticipants received a single preoperative intravenous dose of dexamethasone 4 mg before operative management of hip fracture. |
| placebo | Placebo comparator | Drug: PlaceboParticipants received an equivalent volume of normal saline placebo preoperatively. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneA single 4 mg intravenous dose administered preoperatively. | Drug | Dexamethasone |
| PlaceboParticipants received an equivalent volume of normal saline placebo preoperatively. | Drug | placebo |
Primary outcome
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.
3 secondary outcomes
Delirium severity
Time frame: 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
post operative hyperglycaemia
Time frame: From study drug or placebo administration through hospital discharge, assessed up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Background: PubMed 28093812Smith 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.
- Background: PubMed 33663568Peng 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.
- Background: PubMed 33809573Tarazona-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.
- Results publication: PubMed 33899214Kluger 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.
- Results publication: PubMed 37337260Huang 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.
- Results publication: PubMed 40301442Yang 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.
- Results publication: PubMed 37653739Wang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone in people with Delirium - Postoperative and Hip Fracture Surgeries, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium (time frame: Time Frame: Postoperative Day 1 through Postoperative Day 5, or until hospital discharge, whichever occurs first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07651150, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.