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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

Tracking Information
First Submitted Date September 7, 2019
First Posted Date November 6, 2019
Last Update Posted Date November 6, 2019
Actual Study Start Date February 25, 2019
Estimated Primary Completion Date December 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 4, 2019)
Cognitive dysfunction [ Time Frame: 7 days ]
The occurrence of cognitive dysfunction at approximately 7 days after surgery.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Intranasal Insulin on Postoperative Cognitive Dysfunction
Official Title Effect of Intranasal Insulin on Postoperative Cognitive Dysfunction in Middle Aged Patients Undergoing Non Cadiac Surgery.
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition 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.
Study Groups/Cohorts
  • Control group.
  • Surgical group Received intranasal insulin.
    Intervention: Drug: Intranasal insulin
  • Surgical group Received placebo.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 4, 2019)
57
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 25, 2019
Estimated Primary Completion Date December 25, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Nourhan Mohamed Anter 01100418846 ext 01012660236 nourhananter1992@yahoo.com
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT04154449
Other Study ID Numbers 164: 2/2019
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Yes
Responsible Party Nourhan mohamed anter, Minia University
Study Sponsor Minia University
Collaborators Not Provided
Investigators Not Provided
PRS Account Minia University
Verification Date November 2019