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Effect of Intranasal Insulin on Postoperative Cognitive Dysfunction

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ClinicalTrials.gov Identifier: NCT04154449
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Nourhan mohamed anter, Minia University

Study Description
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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.


Condition or disease Intervention/treatment
Middle Aged Patients Drug: Intranasal insulin

Study Design
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Study Type : Observational
Estimated Enrollment : 57 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effect of Intranasal Insulin on Postoperative Cognitive Dysfunction in Middle Aged Patients Undergoing Non Cadiac Surgery.
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : December 25, 2019
Estimated Study Completion Date : December 25, 2019

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Control group.
Surgical group Received intranasal insulin. 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.
Surgical group Received placebo.


Outcome Measures
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Primary Outcome Measures :
  1. Cognitive dysfunction [ Time Frame: 7 days ]
    The occurrence of cognitive dysfunction at approximately 7 days after surgery.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154449


Contacts
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Contact: Nourhan Mohamed Anter 01100418846 ext 01012660236 nourhananter1992@yahoo.com

Locations
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Egypt
Minia University Recruiting
Minya, Egypt, 61111
Contact: Nourhan NM Mohamed Anter, Resident    01100418846    nourhananter1992@yahoo.com   
Minia university Completed
Minya, Egypt, 61111
Sponsors and Collaborators
Minia University
More Information
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Responsible Party: Nourhan mohamed anter, Resident of anesthesia and Intensive care, Minia University
ClinicalTrials.gov Identifier: NCT04154449    
Other Study ID Numbers: 164: 2/2019
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs