臨床研究等提出・公開システム

Japanese

Date of registration	April. 21, 2023
Last modified on	April. 04, 2024
Trial ID	jRCTs031230047

Scientific Title	Effects of Intranasal insulin administration for postoperative delirium in cardiac surgery patients - prospective multi-center double blind randomised trial -
Public Title	Efficacy trial of intranasal insulin

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

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 21, 2023
Actual date of first enrollment		July. 05, 2023
Target sample size		110
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) 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
	Exclusion Criteria	1) 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
	Age Minimum	65age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Elective cardiac surgery requiring cardiopulmonary bypass
Intervention(s)		Preoperative intranasal insulin administration
Health Condition(s) Keyword		valvular diseases, Ischemic heart diseases
Intervention(s) Keyword		Insulin, intranasal administration,perioperative
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Incidence of delirium within 7 days after surgery
Secondary Outcome(s)		1) 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

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Department fund (Department of Anesthesiology, University of Tsukuba)
Secondary Sponsor	Applicable

Source of Monetary Support	University of Tsukuba Hospital
Secondary Sponsor	Not applicable

Source of Monetary Support	Japan Society for the Promotion of Science
Secondary Sponsor	Not applicable

Name of Certified Review Board	University of Tsukuba Clinical Research Review Board
Address	1-1-1Tennodai, Tsukuba, Ibaraki, Ibaraki
Telephone	+81-29-853-3914
E-Mail	t-credo.adm@un.tsukuba.ac.jp
Approval Status	Approval
Date of approval	Mar. 15, 2023

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	April. 04, 2024	(this page)	Changes
5	Mar. 27, 2024	Detail	Changes
4	July. 07, 2023	Detail	Changes
3	July. 07, 2023	Detail	Changes
2	June. 19, 2023	Detail	Changes
1	April. 21, 2023	Detail

List of change history