Middle Aged PatientsNCT04154449
Effect of Intranasal Insulin on Postoperative Cognitive Dysfunction
An observational study of Middle Aged Patients, run by Minia University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Middle Aged Patients
- What is being tested?
- Intranasal insulin
- How many people
- 57 participants
- Where
- 2 sitesEgypt
- Study dates
- 25 Feb 2019to 25 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 1 recruiting
- Recruiting
Minia University
Minya, 61111
Nourhan NM Mohamed Anter, Resident, 01100418846, nourhananter1992@yahoo.com
- Completed
Minia university
Minya, 61111
About this study
Official title: 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:
- The occurrence of cognitive dysfunction at approximately 7 days after surgery.
Secondary outcome:
- Incidence of any side effect.
- Conditions
- Middle Aged Patients
- Being tested
- Intranasal insulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal insulinDrug
Surgical group Received intranasal insulin, the second group surgical Received placebo and the third group is non surgical do not receive anything.
| Study group | Role | What they receive |
|---|---|---|
| Control group. | Not described | |
| Surgical group Received intranasal insulin. | Not described Receives: Drug: Intranasal insulin | |
| Surgical group Received placebo. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive dysfunction
The occurrence of cognitive dysfunction at approximately 7 days after surgery.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start25 Feb 2019
- Primary completion25 Dec 2019 (estimated)
- Study completion25 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Middle Aged PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan mohamed anter, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154449
- Sponsor's protocol ID
- 164: 2/2019
- Status last verified
- Nov 2019
- First submitted
- 7 Sep 2019
- Last updated
- 6 Nov 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intranasal Insulin on Postoperative Cognitive Dysfunction in Middle Aged Patients Undergoing Non Cadiac Surgery.
- ClinicalTrials.gov ID
- NCT04154449
- Acronym / sponsor ID
- 164: 2/2019
- Conditions
- Middle Aged Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 25 Dec 2019 (estimated)
- Study completion
- 25 Dec 2019 (estimated)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our study is designed to evaluate the effect of intranasal insulin on postoperative cognitive dysfunction.
Primary outcome:
- The occurrence of cognitive dysfunction at approximately 7 days after surgery.
Secondary outcome:
- Incidence of any side effect.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group. | – | – |
| Surgical group Received intranasal insulin. | – | Drug: Intranasal insulin |
| Surgical group Received placebo. | – | – |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal insulinSurgical group Received intranasal insulin, the second group surgical Received placebo and the third group is non surgical do not receive anything. | Drug | Surgical group Received intranasal insulin. |
Primary outcome
Cognitive dysfunction
Time frame: 7 days
The occurrence of cognitive dysfunction at approximately 7 days after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Middle Aged Patients, run by Minia University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nourhan Mohamed Anter (01100418846 ext. 01012660236, nourhananter1992@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive dysfunction (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019; AzTrials last refreshed its copy on 31 Oct 2026.