Effect of Intranasal Insulin on Postoperative Cognitive Dysfunction
1 other identifier
observational
57
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2019
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 25, 2019
CompletedFirst Submitted
Initial submission to the registry
September 7, 2019
CompletedFirst Posted
Study publicly available on registry
November 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 25, 2019
CompletedNovember 6, 2019
November 1, 2019
10 months
September 7, 2019
November 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Cognitive dysfunction
The occurrence of cognitive dysfunction at approximately 7 days after surgery.
7 days
Study Arms (3)
Control group.
Surgical group Received intranasal insulin.
Surgical group Received placebo.
Interventions
Surgical group Received intranasal insulin, the second group surgical Received placebo and the third group is non surgical do not receive anything.
Eligibility 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.
You may qualify if:
- Age 40 - 60 years.
- Both gender.
- 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.
You may not qualify if:
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Minia Universitylead
Study Sites (2)
Minia University
Minya, 61111, Egypt
Minia university
Minya, 61111, Egypt
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident of anesthesia and Intensive care
Study Record Dates
First Submitted
September 7, 2019
First Posted
November 6, 2019
Study Start
February 25, 2019
Primary Completion
December 25, 2019
Study Completion
December 25, 2019
Last Updated
November 6, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will share