Safety evaluation of intranasal insulin administration

JRCT ID: jRCTs031200290

Registered date:12/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: patients with scheduled cardiac surgery requiring cardiopulmonary bypass
• Date of first enrollment: 03/02/2021
• Target sample size: 30
• Study type: Interventional
• Intervention(s): preoperative intranasal insulin administration

Outcome(s)

• Primary Outcome: Hypoglycemia (blood glucose < 70/mg) after intranasal insulin administration

Secondary Outcome

Change in blood glucose at 30 and 40 min after intranasal insulin administration
Change in plasma insulin at 10, 20, 30 and 40 min after intranasal insulin administration
Change in plasma C peptide at 10, 20, 30 and 40 min after intranasal insulin administration
Incidence of postoperative liver dysfunction
Incidence of postoperative renal dysfunction
Incidence of postoperative heart failure
Incidence of postoperative infection
Incidence of postoperative arrhythmia
Incidence of death within 7days after surgery
Incidence of postoperative delirium (POD)
Change in intracerebral oxygen saturation (NIRS) during surgery
Change in inflammatory cytokine (IL6, IL1 beta, TNF alpha)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patients scheduled elective cardiac surgery or major vascular surgery with cardiopulmonary bypass
2)Patients who are 20 years old or older
3)Patients with 1.5 mg/dL or less preoperative creatinine
4)Patients who had not undergone nasal surgery
5)Patients with written consent
6)Patients who are able to communicate with Japanese

Exclude criteria

1 Patients had 23 or less preoperative MMSE score
2 Patients with insulin allergy
3 Patients under mechanical ventilation
4 Patients with severe psychological disorder
5 Patients with severe liver dysfunction
6 Patients with severe infectious diseases
7)Patients with severe cerebral infarction
8)Patients with dyspituitarism or adrenal insufficiency

Related Information

• Primary Sponsor: Kawakami Akiko