Effect of Intranasal Insulin on Postoperative Cognitive Dysfunction

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

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.

Study Overview

• Status: Unknown
• Conditions: Middle Aged Patients
• Intervention / Treatment: Drug: Intranasal insulin

• Study Type: Observational
• Enrollment (Anticipated): 57

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt, 61111
    • Recruiting
    • Minia University
    • Contact: Nourhan NM Mohamed Anter, Resident; Phone Number: 01100418846; Email: nourhananter1992@yahoo.com
  • Minya, Egypt, 61111
    • Completed
    • Minia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive dysfunction	The occurrence of cognitive dysfunction at approximately 7 days after surgery.	7 days

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2019
• Primary Completion (Anticipated): December 25, 2019
• Study Completion (Anticipated): December 25, 2019

Study Registration Dates

• First Submitted: September 7, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): November 6, 2019
• Last Update Submitted That Met QC Criteria: November 4, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Postoperative Cognitive Complications; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 164: 2/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• 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