NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031230047

Registered date:21/04/2023

Efficacy trial of intranasal insulin

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedElective cardiac surgery requiring cardiopulmonary bypass
Date of first enrollment05/07/2023
Target sample size110
Countries of recruitment
Study typeInterventional
Intervention(s)Preoperative intranasal insulin administration

Outcome(s)

Primary OutcomeIncidence of delirium within 7 days after surgery
Secondary Outcome1) 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 maximumNot applicable
GenderBoth
Include criteria1) 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 criteria1) 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

Contact

Public contact
Name Yosuke Nakadate
Address 2-1-1 Amakubo,Tsukuba,Ibaraki Ibaraki Japan 305-8576
Telephone +81-29-853-3092
E-mail nakadate.ge@md.tsukuba.ac.jp
Affiliation University of Tsukuba Hospital
Scientific contact
Name Yosuke Nakadate
Address 2-1-1 Amakubo,Tsukuba,Ibaraki Ibaraki Japan 305-8576
Telephone +81-29-853-3092
E-mail nakadate.ge@md.tsukuba.ac.jp
Affiliation University of Tsukuba Hospital