Postoperative delirium prevention using hydrocortisone

JRCT ID: jRCTs041240032

Registered date:24/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: digestive disease
• Date of first enrollment: 24/05/2024
• Target sample size: 180
• Study type: Interventional
• Intervention(s): A single 500 mg dose of hydrocortisone intravenously is administered immediately before the surgery.

Outcome(s)

• Primary Outcome: The incidence of delirium during the first 3 days after surgery

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patients scheduled for digestive surgery including laparotomy, laparoscopic gastrointestinal 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.

Exclude 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 communication barriers who could not complete the cognitive function test.
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.

Related Information

• Primary Sponsor: Yokoyama Yukihiro