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Postoperative delirium prevention using hydrocortisone

A double-blind, randomized controlled trial of hydrocortisone to prevent postoperative delirium in patients undergoing digestive surgery

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041240032
Enrollment
180
Registered
2024-05-24
Start date
2024-06-27
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

digestive disease gastrointestinal disease, hepato-biliary-pancreatic disease

Interventions

A single 500 mg dose of hydrocortisone intravenously is administered immediately before the surgery.
hydrocortisone

Sponsors

Yokoyama Yukihiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients scheduled for digestive surgery, including laparotomy, laparoscopic gastrointestinal surgery, laparoscopic hepatectomy, robot-assisted hepatectomy, laparoscopic distal pancreatectomy, robot-assisted pancreatic surgery and laparoscopic cholecystectomy for cholecystitis. 2)Patients who have understood and agreed the concept of the study. 3)Age more than 65, regardless of gender.

Exclusion criteria

Exclusion criteria: 1)Patients with allergic to hydrocortisone. 2)Patients receiving systemic corticoids or immunosuppressive therapy. 3)Patients with active peptic ulcer disease. 4)Patients with insulin-dependent diabetes mellitus. 5)Patients with a history of stroke within 3 months. 6) Patients with no history of measles or varicella and who have not been vaccinated. 7) Patients with a history of hepatitis B or hepatitis C. 8)Patients with severe communication disorders in vision or hearing 9)Patients with unstable mental status or psychiatric disorders. 10)Patients who are currently participating in other intervention studies that may affect the results of this study. 11)Patients scheduled for inguinal hernia surgery and laparoscopic cholecystectomy for non-inflammatory gallbladder stones or gallbladder polyps. 12)Patients undergoing emergency surgery.

Design outcomes

Primary

MeasureTime frame
The incidence of delirium during the first 3 days after surgery

Secondary

MeasureTime frame
1)Change in blood sodium levels on postoperative days 1 and 3 compared to preoperative levels 2)Death within 90 days of surgery 3)Postoperative hospital stay 4)Change in FIM (functional independence measure) from admission to discharge. 5)Identification of predictors of delirium up to the third postoperative day, and construction of a formula for predicting the probability of delirium

Contacts

Public ContactTomoki Ebata

Nagoya University Hospital

ebata.tomoki.n1@f.mail.nagoya-u.ac.jp+81-52-744-2222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026