Prevention of postoperative delirium in elderly patients

JRCT ID: jRCTs051180134

Registered date:18/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Gastroenterological cancer
• Date of first enrollment: 16/11/2017
• Target sample size: 290
• Study type: Interventional

Intervention(s)

Arm A: none
Arm B: Oral administration of TJ-45 for 7days before operation

Outcome(s)

• Primary Outcome: Incidence of postoperative delirium
• Secondary Outcome: Duration of postoperative delirium, postoperative complications, duration of postoperative hospital stay, outcome at discharge, changes of G8 score and cognitive function, nutrtional status, prognosis.

Key inclusion & exclusion criteria

• Age minimum: >= 75age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.75 years old or older patients with gastroenterological cancer
2.Elective surgical case with curative intent
3.Scheduled for laparotomy or laparoscopic surgery
4.PS(ECOG) 0-2
5.Adequate organ function

Exclude criteria

1. Unable to eat foods
2. Scheduled for thoracotomy or tholacoscopic surgery
3. Double cancer
4. Antipsychotics, antidepressant, or narcotics medication within 6 months
5. Dementia

Related Information

• Primary Sponsor: Motoori Masaaki
• Source(s) of Monetary Support: The Supporting Center for Clinical Research and Education
• Secondary ID(s): UMIN000027967