Effect of Intranasal Insulin on Postoperative Cognitive Dysfunction

Middle Aged Patients Clinical Trial

Official title:

Effect of Intranasal Insulin on Postoperative Cognitive Dysfunction in Middle Aged Patients Undergoing Non Cadiac Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04154449
• Other study ID #: 164: 2/2019
• Status: Recruiting
• Start date: February 25, 2019
• Est. completion date: December 25, 2019

Study information

• Verified date: November 2019
• Source: Minia University
• Contact: Nourhan Mohamed Anter
• Phone: 01100418846
• Email: nourhananter1992[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Our study is designed to evaluate the effect of intranasal insulin on postoperative cognitive dysfunction.

Primary outcome:

1. The occurrence of cognitive dysfunction at approximately 7 days after surgery.

Secondary outcome:

1. Incidence of any side effect.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 57
• Est. completion date: December 25, 2019
• Est. primary completion date: December 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Age 40 - 60 years.

2. Both gender.

3. Patients will be scheduled for elective major abdominal, thoracic, orthopedic, open gynecological, open urological, spine, otolaryngological surgeries under general anesthesia with expected hospital stay >4 days.

Exclusion Criteria:

• 1. Drug allergy. 2. Patients with major psychiatric disease. 3. Patients receive major tranquillizers and antidepressant. 4. Those undergoing neurosurgery or cardiac surgery. 5. Those unable or unwilling to abide by the study procedure 6. Those who could not follow procedure or who had poor comprehension of dutch language. 7. Those with sever visual and auditory disorder / handicaps.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Middle Aged Patients

Intervention

Drug:
• Intranasal insulin
Surgical group Received intranasal insulin, the second group surgical Received placebo and the third group is non surgical do not receive anything.

Locations

Country	Name	City	State
Egypt	Minia University	Minya
Egypt	Minia university	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive dysfunction	The occurrence of cognitive dysfunction at approximately 7 days after surgery.	7 days