Hypotension; ControlledNCT04948957
Changes in Cerebral Oxygenation and Cognitive Functions
An observational study of Hypotension; Controlled and Cognitive Dysfunction, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
The present study aimed to assess the influence of nitroglycerin and esmolol-induced hypotension on cerebral oxygen saturation by using near-infrared spectroscopy and postoperative cognitive function in patients undergoing nasal surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypotension; Controlled, Cognitive Dysfunction
- What is being tested?
- Esmolol and Nitroglycerin
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2014to 1 Aug 2016
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: - required controlled hypotension scheduled for nasal surgeries
Who may be able to join
- written informed consent
- patients with ASA physical status of I-II
- aged 18-65 years
Who cannot join
- Age under 18 or above 65
- ASA > II
- coagulation disorders
- history of cardiovascular and cerebrovascular disease
- poor Blood Pressure control
- anemia, pregnancy, addiction to opioids
Show all 11Show fewer
- body mass index (BMI) > 35
- intraoperative systolic BP < 65 mmHg
- surgical duration less than 30 minutes or more than 160 minutes
- need for an intraoperative sympathomimetic drug and the use of other hypotensive drugs
- preoperative Mini-Mental State Examination (MMSE) score of 23 or less.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University Medicine Faculty
Zonguldak, Kozlu, 67600
About this study
Official title: Changes in Cerebral Oxygenation and Cognitive Functions During Controlled Hypotension
The present study aimed to assess the influence of nitroglycerin and esmolol-induced hypotension on cerebral oxygen saturation by using near-infrared spectroscopy and postoperative cognitive function in patients undergoing nasal surgery.
- Conditions
- Hypotension; Controlled, Cognitive Dysfunction
- Being tested
- Esmolol, Nitroglycerin
- Keywords
- cerebral oxygenation, cognitive function, esmolol, nitroglycerine
- Medical subject headings
- Hypotension, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsmololDrug
NitroglycerinDrug
| Study group | Role | What they receive |
|---|---|---|
| esmolol (Group E) | Not described Receives: Drug: Esmolol | |
| nitroglycerin (Group N) | Not described Receives: Drug: Nitroglycerin |
What is being measured
The primary outcome is the main question the study is designed to answer.
effects of controlled hypotension on cerebral oxygen saturation
influence of nitroglycerin and esmolol-induced hypotension on cerebral oxygen saturation by measuring regional cerebral oxygen saturation using Near-Infrared Spectroscopy
Measured: until end of the surgical procedure.
Secondary outcomes (1)
effects of controlled hypotension on cognitive function
influence of nitroglycerin and esmolol-induced hypotension on postoperative cognitive function using mini mental test score
Measured: 24 hour before surgery and 24 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start1 Mar 2014
- Primary completion1 Jan 2016
- Study completion1 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension; ControlledStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bengü Gülhan Aydin, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948957
- Sponsor's protocol ID
- 2013-81-03/09
- Status last verified
- Jun 2021
- First submitted
- 12 Jun 2021
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Cerebral Oxygenation and Cognitive Functions During Controlled Hypotension
- ClinicalTrials.gov ID
- NCT04948957
- Acronym / sponsor ID
- 2013-81-03/09
- Conditions
- Hypotension; Controlled, Cognitive Dysfunction
- Keywords
- cerebral oxygenation, cognitive function, esmolol, nitroglycerine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Aug 2016 (actual)
- First posted
- 2 Jul 2021 (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.
The present study aimed to assess the influence of nitroglycerin and esmolol-induced hypotension on cerebral oxygen saturation by using near-infrared spectroscopy and postoperative cognitive function in patients undergoing nasal surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| esmolol (Group E) | – | Drug: Esmolol |
| nitroglycerin (Group N) | – | Drug: Nitroglycerin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- - required controlled hypotension scheduled for nasal surgeries
Key inclusion criteria (3 listed)
- written informed consent
- patients with ASA physical status of I-II
- aged 18-65 years
Key exclusion criteria (11 listed)
- Age under 18 or above 65
- ASA > II
- coagulation disorders
- history of cardiovascular and cerebrovascular disease
- poor Blood Pressure control
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 |
|---|---|---|
| Esmolol | Drug | esmolol (Group E) |
| Nitroglycerin | Drug | nitroglycerin (Group N) |
Primary outcome
effects of controlled hypotension on cerebral oxygen saturation
Time frame: until end of the surgical procedure.
influence of nitroglycerin and esmolol-induced hypotension on cerebral oxygen saturation by measuring regional cerebral oxygen saturation using Near-Infrared Spectroscopy
1 secondary outcome
effects of controlled hypotension on cognitive function
Time frame: 24 hour before surgery and 24 hour after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension; Controlled and Cognitive Dysfunction, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
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 11 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: finished, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effects of controlled hypotension on cerebral oxygen saturation (time frame: until end of the surgical procedure.). 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 2 Jul 2021; AzTrials last refreshed its copy on 26 Oct 2026.