Effect of Intranasal Insulin on Postoperative Cognitive Dysfunction

NCT ID: NCT04154449

Last Updated: 2019-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-25

Study Completion Date

2019-12-25

Brief Summary

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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.

Detailed Description

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Conditions

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Middle Aged Patients

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group.

No interventions assigned to this group

Surgical group Received intranasal insulin.

Intranasal insulin

Intervention Type DRUG

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.

No interventions assigned to this group

Interventions

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Intranasal insulin

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Nourhan mohamed anter

Resident of anesthesia and Intensive care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Minia University

Minya, , Egypt

Site Status RECRUITING

Minia university

Minya, , Egypt

Site Status COMPLETED

Countries

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Egypt

Central Contacts

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Nourhan Mohamed Anter

Role: CONTACT

01100418846 ext. 01012660236

Facility Contacts

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Nourhan NM Mohamed Anter, Resident

Role: primary

01100418846

Other Identifiers

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164: 2/2019

Identifier Type: -

Identifier Source: org_study_id

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