Safety evaluation of intranasal insulin administration

Safety evaluation of intranasal insulin administration during cardiac surgery for preventing postoperative delirium and cognitive dysfunction

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031200290

Enrollment

Registered

2021-01-12

Start date

2021-02-03

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

patients with scheduled cardiac surgery requiring cardiopulmonary bypass ischemic heart diseases, valvular diseases, major vascular diseases

Interventions

preoperative intranasal insulin administration

Insulin, intranasal administration, perioperative

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Hypoglycemia (blood glucose < 70/mg) after intranasal insulin administration	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Contacts

Public ContactAkiko Kawakami

University of Yamanashi Hospital

akawakami@yamanashi.ac.jp+81-55-273-1111

Outcome results

None listed

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