Effect of intranasal insulin administration on postoperative delirium prevention in elderly cardiac surgery patients: study protocol for a multicenter, double-blind, randomized, controlled trial

• Published in: Current controlled trials in cardiovascular medicine Vol. 24; no. 1; p. 822
• Main Authors: Nakadate, Yosuke, Yamada, Mariko, Kusuyama, Natsuyo, Ishii, Ryota, Sato, Hiroaki, Schricker, Thomas, Tanaka, Makoto
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 21.12.2023; BioMed Central; BMC
• Subjects: Aged; Aged patients; Anesthesia; Anesthesiology; Blood pressure; Brain research; Cardiac surgery; Cardiac Surgical Procedures - adverse effects; Cardiopulmonary bypass; Care and treatment; Catheters; Cognitive ability; Complications and side effects; Consciousness; Consent; Coronary artery bypass; Corporate sponsorship; Delirium; Delirium - diagnosis; Delirium - etiology; Delirium - prevention & control; Disease; Dosage and administration; Double-Blind Method; Drug dosages; Emergence Delirium - etiology; Glucose; Health aspects; Heart surgery; Hospitals; Humans; Hypoglycemia; Inflammation; Insulin; Insulin - adverse effects; Intranasal insulin administration; Intranasal medication; Multicenter Studies as Topic; Postoperative Complications - diagnosis; Postoperative Complications - etiology; Postoperative Complications - prevention & control; Postoperative delirium; Prevention; Pulmonary arteries; Randomized Controlled Trials as Topic; Risk factors; Study Protocol; Japan; Cardiopulmonary bypass; Intranasal insulin administration; Cardiac surgery; Postoperative delirium
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-023-07860-6

Postoperative delirium (POD) is a complication after surgery which leads to worse outcomes. The frequency of this syndrome is increasing as more elderly patients undergo major surgery. The frequency is around 10-25% but reaches as high as 50% for cardiac surgery. Although intranasal insulin (INI) administration of up to 160 units in patients with cognitive dysfunction and delirium has been shown to improve memory function and brain metabolism without complications such as hypoglycemia, it remains unknown whether INI prevents POD after cardiac surgery METHODS: A multicenter, double-blind, randomized, controlled trial will be conducted at University of Tsukuba Hospital and Tsukuba Medical Center Hospital, Japan, from July 1, 2023, to December 31, 2025. A total of 110 elderly patients (65 years old or older) undergoing cardiac surgery requiring cardiopulmonary bypass will be enrolled and randomly allocated to intranasal insulin or intranasal saline groups. The primary outcome is the incidence of POD within 7 days after surgery. Secondary outcomes include days and times of delirium, screening tests of cognitive function, pain scores, duration of postoperative tracheal intubation, and length of ICU stay. The present objective is to assess whether 80 IU INI administration during surgery prevents POD after cardiac surgery. The results may provide strategic choices to prevent POD in patients with cardiac surgery requiring cardiopulmonary bypass. The trial was registered with the Japan Registry for Clinical Trials with identifier jRCTs031230047  on April 21, 2023.