Safety evaluation of intranasal insulin administratio

Phase 1

• Conditions: patients with scheduled cardiac surgery requiring cardiopulmonary bypass; ischemic heart diseases, valvular diseases, major vascular diseases

• Registration Number: JPRN-jRCTs031200290
• Lead Sponsor: Kawakami Akiko

Brief Summary

Intranasal insulin administration 160 unit and less did not cause hypoglycemia. We need further study regarding minor complications.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-12
• Study Completion: 2021-10-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 27

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified