Efficacy trial of intranasal insulin

JRCT ID: jRCTs031230047

Registered date:21/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Elective cardiac surgery requiring cardiopulmonary bypass
• Date of first enrollment: 05/07/2023
• Target sample size: 110
• Study type: Interventional
• Intervention(s): Preoperative intranasal insulin administration

Outcome(s)

• Primary Outcome: Incidence of delirium within 7 days after surgery

Secondary Outcome

1) Days of postoperative delirium
2) Number of postoperative delirium
3) Change in MMSE-J score at 7days after surgery compared to before surgery
4) Change in MoCA-J score at 7days after surgery compared to before surgery
5) Postoperative pain score (Numerical rating scale)
6) Postoperative tracheal intubation time
7) Length of intensive care unit stay
8) Incidence of hypoglycemia
9) Incidence of postoperataive renal
10) Incidence of postoperative heart failure
11) Incidence of postoperative infection
12) Incidence of atrial fibrillation
13) Postoperative 7-day mortality rate
14) Incidence of all of adverse events

Key inclusion & exclusion criteria

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

Include criteria

1) Patients undergoing elective cardiac surgery requiring cardiopulmonary bypass
2) Patients who are 65 years old or older
3) Patietns who had not undergone nasal surgery
4) Patiets who provide signed informed consent to participate in the registry

Exclude criteria

1) Patietns with preoperative delirium
2) Patients whose preoperative MMSE examination is 23 or less
3) Patients undergone cardiac surgery under hypothermia (< 32 degree celcius) condition
4) Patients with insulin allergy
5) Patietns with severe phycological disorder
6) Patients with severe neurological disorder
7) Patietns with severe hearing and/or visual impairment
8) Patients with Japanese language disability
9) Patients who are judged inappropriate by researchers

Related Information

• Primary Sponsor: Nakadate Yosuke
• Secondary Sponsor: Department fund (Department of Anesthesiology, University of Tsukuba)
• Source(s) of Monetary Support: University of Tsukuba Hospital,Japan Society for the Promotion of Science