Cognitive DysfunctionNCT06925711
The Effect of Hypotensive Anesthesia on Cognitive Functions in Orthognatic Surgery
An observational study of Cognitive Dysfunction and Postoperative Complications, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate the effects of maintaining adequate cerebral oxygen saturation on patients undergoing orthognathic surgery. Orthognathic surgery is performed to repair anomalies in the maxillofacial skeleton for both aesthetic and functional purposes. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Dysfunction, Postoperative Complications
- What is being tested?
- Near-Infrared Spectroscopy (NIRS)
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Dec 2022to 19 Feb 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients of both genders, over 18 years of age, undergoing elective Orthognathic surgery in general anesthesia.
Who may be able to join
- Patients undergoing Orthognathic surgery under general anesthesia ASA grade ≤ grade III; Patients can communicate normally, can cooperate and complete cognitive function test; Patients volunteered and signed informed consent.
Who cannot join
- BMI < 18 or > 27 kg / m2; Previous history of dementia, psychosis or other central nervous system diseases or mental diseases, such as cerebral infarction, stroke, Parkinson's disease, etc; Patients taking sedatives or antidepressants; Alcoholics or drug addicts; Patients with cognitive impairment before operation (MMSE score < 23); Patients with peripheral vascular diseases and contraindication of arterial puncture and catheterization; Patients unable to carry out long-term follow-up or poor compliance.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Hospital
Istanbul, 34070
About this study
Official title: Investigation of the Effect of Hypotensive Anesthesia on Cognitive Functions in Orthognathic Surgery
The purpose of this study is to evaluate the effects of maintaining adequate cerebral oxygen saturation on patients undergoing orthognathic surgery. Orthognathic surgery is performed to repair anomalies in the maxillofacial skeleton for both aesthetic and functional purposes. During these procedures, controlled hypotensive anesthesia is commonly used to reduce bleeding, improve surgical field visibility, and shorten operation time.
In controlled hypotensive anesthesia, mean arterial blood pressure is deliberately reduced to approximately 55-60 mmHg. While this technique offers surgical advantages, it may potentially reduce cerebral blood flow and oxygen saturation, which could affect cognitive function.
This study will investigate the relationship between cerebral oxygen saturation levels maintained during orthognathic surgery and postoperative neuropsychological outcomes. Patients will undergo cognitive assessments before and after surgery while cerebral oxygen saturation is continuously monitored during the procedure. Our findings will help establish safety parameters for hypotensive anesthesia in orthognathic surgery and potentially contribute to improved anesthesia management protocols that better preserve cognitive function.
Read the detailed description
Orthognathic surgery is a surgical procedure performed to repair anomalies in the maxillofacial skeleton. It can be performed for maxillofacial aesthetics as well as for functional purposes. Since orthognathic surgery is performed in a field where vascular structures are dense, complications such as intraoperative bleeding are likely to occur.
Le Fort I osteotomy and bilateral sagittal split ramus osteotomy (BSSRO) are frequently used treatment methods for dentofacial deformities. Significant bleeding may occur especially during Le Fort I osteotomy. Therefore, controlled hypotensive anesthesia is frequently used during maxillofacial surgery procedures to reduce bleeding, increase the visibility of the surgical field, and prevent blood loss.
During controlled hypotensive anesthesia, mean arterial blood pressure (MAP) is reduced to around 55-60 mmHg. This technique makes the operation more comfortable for both the surgical team and the anesthesia team. Vasoactive and anesthetic agents such as direct-acting vasodilators, autonomic ganglion blockers, beta-adrenergic receptor blockers, and calcium channel blockers are used to provide hypotensive anesthesia.
However, prolonged hypotension may lead to organ damage due to hypoperfusion. Uncontrolled prolongation of systemic hypotension may cause cerebral ischemia, neuronal death, and permanent brain damage by causing a decrease in cerebral blood flow. Cerebral circulation has a complex and unpredictable autoregulatory mechanism. Therefore, it is difficult to maintain the balance between hypotension and cerebral perfusion.
Changes in cerebral blood flow and cerebral tissue perfusion may cause cognitive changes because they affect the nutrition of neural tissues. The aim of this study is to evaluate the effects of controlled hypotensive anesthesia applied in orthognathic surgery on intraoperative cerebral blood flow-cerebral oxygen saturation and cognitive functions of patients and to determine the degree of these effects.
As part of the study, cognitive function tests will be performed on the patient population before and after surgery, and cerebral oxygen saturation will be continuously monitored during surgery. The results may help determine the safety limits of hypotensive anesthesia applied during orthognathic surgery and potentially develop cerebral protection strategies.
The results of this research are expected to contribute to the development of new approaches to improve anesthesia management in patients undergoing orthognathic surgery. Additionally, by testing the hypothesis that maintaining cerebral oxygen saturation may improve cognitive outcomes, it can contribute to increasing patient safety in maxillofacial surgical practices.
- Conditions
- Cognitive Dysfunction, Postoperative Complications
- Being tested
- Near-Infrared Spectroscopy (NIRS)
- Keywords
- orthognathic surgery, hypotensive anesthesia, cerebral oxygen saturation
- Medical subject headings
- Cognitive Dysfunction, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-Infrared Spectroscopy (NIRS)Device
Controlled hypotensive anesthesia during orthognathic surgery with cerebral oxygen saturation monitoring using Near-Infrared Spectroscopy (NIRS). NIRS was used to continuously monitor regional cerebral oxygen saturation (rSO2) throughout the procedure to observe the effects of controlled hypotension on cerebral perfusion
| Study group | Role | What they receive |
|---|---|---|
| Patients aged 18 years and older with ASA I-II scores who were diagnosed with dentofacial deformity | Not described Receives: Device: Near-Infrared Spectroscopy (NIRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive function measured by Mini-Mental State Examination (MMSE) scores
The Mini-Mental State Examination (MMSE) is a 30-point questionnaire used extensively in clinical and research settings to measure cognitive impairment. It will be used to assess changes in cognitive function that may be associated with cerebral oxygen saturation levels during controlled hypotensive anesthesia in orthognathic surgery.
Measured: Baseline (7 days before surgery), postoperative 10th day, 1st month, and 3rd month after surgery
Secondary outcomes (1)
Incidence and severity of cerebral oxygen desaturation events during controlled hypotensive anesthesia
Cerebral oxygen saturation (rSO2) will be continuously monitored bilaterally using Near-Infrared Spectroscopy (NIRS) during surgery. Cerebral oxygen desaturation events are defined as a decrease in rSO2 of >20% from baseline or an absolute value <50% lasting more than 15 seconds. The number, duration, and severity of these events will be recorded and analyzed for correlation with cognitive outcomes.
Measured: Intraoperatively, from induction of anesthesia until extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start19 Dec 2022
- Primary completion17 Nov 2023
- Study completion19 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tumay Uludag Yanaral, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925711
- Sponsor's protocol ID
- MEDIPOLU-6143
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li X, Zheng Y, Zhang J. Cerebral oxygenation and hemodynamic changes during ephedrine and phenylephrine administration for transient intraoperative hypotension in patients undergoing major abdominal surgery: a randomized controlled trial. BMC Anesthesiol. 2025 Feb 20;25(1):87. doi: 10.1186/s12871-025-02944-z.
PubMed 39979813Hsiao YC, Chang YT, Cheng CS, Lien KH. Dexmedetomidine infusion on blood loss in orthognathic surgery: A retrospective study on its efficacy. J Formos Med Assoc. 2026 Apr;125(4):387-390. doi: 10.1016/j.jfma.2025.02.009. Epub 2025 Feb 13. No abstract available.
PubMed 39952888Ravelo V, Olate S, Bravo-Soto G, Zaror C, Mommaerts M. Systematic review of soft-to-hard tissue ratios in orthognathic surgery: 3D analysis-update of scientific evidence. Int J Oral Maxillofac Surg. 2025 Sep;54(9):819-829. doi: 10.1016/j.ijom.2025.02.008. Epub 2025 Mar 17.
PubMed 40102081
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Hypotensive Anesthesia on Cognitive Functions in Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT06925711
- Acronym / sponsor ID
- MEDIPOLU-6143
- Conditions
- Cognitive Dysfunction, Postoperative Complications
- Keywords
- orthognathic surgery, hypotensive anesthesia, cerebral oxygen saturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 19 Feb 2024 (actual)
- First posted
- 13 Apr 2025 (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 purpose of this study is to evaluate the effects of maintaining adequate cerebral oxygen saturation on patients undergoing orthognathic surgery. Orthognathic surgery is performed to repair anomalies in the maxillofacial skeleton for both aesthetic and functional purposes. During these procedures, controlled hypotensive anesthesia is commonly used to reduce bleeding, improve surgical field visibility, and shorten operation time.
In controlled hypotensive anesthesia, mean arterial blood pressure is deliberately reduced to approximately 55-60 mmHg. While this technique offers surgical advantages, it may potentially reduce cerebral blood flow and oxygen saturation, which could affect cognitive function.
This study will investigate the relationship between cerebral oxygen saturation levels maintained during orthognathic surgery and postoperative neuropsychological outcomes. Patients will undergo cognitive assessments before and after surgery while cerebral oxygen saturation is continuously monitored during the procedure. Our findings will help establish safety parameters for hypotensive anesthesia in orthognathic surgery and potentially contribute to improved anesthesia management protocols that better preserve cognitive function.
Detailed description
Orthognathic surgery is a surgical procedure performed to repair anomalies in the maxillofacial skeleton. It can be performed for maxillofacial aesthetics as well as for functional purposes. Since orthognathic surgery is performed in a field where vascular structures are dense, complications such as intraoperative bleeding are likely to occur.
Le Fort I osteotomy and bilateral sagittal split ramus osteotomy (BSSRO) are frequently used treatment methods for dentofacial deformities. Significant bleeding may occur especially during Le Fort I osteotomy. Therefore, controlled hypotensive anesthesia is frequently used during maxillofacial surgery procedures to reduce bleeding, increase the visibility of the surgical field, and prevent blood loss.
During controlled hypotensive anesthesia, mean arterial blood pressure (MAP) is reduced to around 55-60 mmHg. This technique makes the operation more comfortable for both the surgical team and the anesthesia team. Vasoactive and anesthetic agents such as direct-acting vasodilators, autonomic ganglion blockers, beta-adrenergic receptor blockers, and calcium channel blockers are used to provide hypotensive anesthesia.
However, prolonged hypotension may lead to organ damage due to hypoperfusion. Uncontrolled prolongation of systemic hypotension may cause cerebral ischemia, neuronal death, and permanent brain damage by causing a decrease in cerebral blood flow. Cerebral circulation has a complex and unpredictable autoregulatory mechanism. Therefore, it is difficult to maintain the balance between hypotension and cerebral perfusion.
Changes in cerebral blood flow and cerebral tissue perfusion may cause cognitive changes because they affect the nutrition of neural tissues. The aim of this study is to evaluate the effects of controlled hypotensive anesthesia applied in orthognathic surgery on intraoperative cerebral blood flow-cerebral oxygen saturation and cognitive functions of patients and to determine the degree of these effects.
As part of the study, cognitive function tests will be performed on the patient population before and after surgery, and cerebral oxygen saturation will be continuously monitored during surgery. The results may help determine the safety limits of hypotensive anesthesia applied during orthognathic surgery and potentially develop cerebral protection strategies.
The results of this research are expected to contribute to the development of new approaches to improve anesthesia management in patients undergoing orthognathic surgery. Additionally, by testing the hypothesis that maintaining cerebral oxygen saturation may improve cognitive outcomes, it can contribute to increasing patient safety in maxillofacial surgical practices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients aged 18 years and older with ASA I-II scores who were diagnosed with dentofacial deformity | – | Device: Near-Infrared Spectroscopy (NIRS) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients of both genders, over 18 years of age, undergoing elective Orthognathic surgery in general anesthesia.
Key inclusion criteria (1 listed)
- Patients undergoing Orthognathic surgery under general anesthesia ASA grade ≤ grade III; Patients can communicate normally, can cooperate and complete cognitive function test; Patients volunteered and signed informed consent.
Key exclusion criteria (1 listed)
- BMI < 18 or > 27 kg / m2; Previous history of dementia, psychosis or other central nervous system diseases or mental diseases, such as cerebral infarction, stroke, Parkinson's disease, etc; Patients taking sedatives or antidepressants; Alcoholics or drug addicts; Patients with cognitive impairment before operation (MMSE score < 23); Patients with peripheral vascular diseases and contraindication of arterial puncture and catheterization; Patients unable to carry out long-term follow-up or poor compliance.
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 |
|---|---|---|
| Near-Infrared Spectroscopy (NIRS)Controlled hypotensive anesthesia during orthognathic surgery with cerebral oxygen saturation monitoring using Near-Infrared Spectroscopy (NIRS). NIRS was used to continuously monitor regional cerebral oxygen saturation (rSO2) throughout the procedure to observe the effects of controlled hypotension on cerebral perfusion | Device | Patients aged 18 years and older with ASA I-II scores who were diagnosed with dentofacial deformity |
Primary outcome
Change in cognitive function measured by Mini-Mental State Examination (MMSE) scores
Time frame: Baseline (7 days before surgery), postoperative 10th day, 1st month, and 3rd month after surgery
The Mini-Mental State Examination (MMSE) is a 30-point questionnaire used extensively in clinical and research settings to measure cognitive impairment. It will be used to assess changes in cognitive function that may be associated with cerebral oxygen saturation levels during controlled hypotensive anesthesia in orthognathic surgery.
1 secondary outcome
Incidence and severity of cerebral oxygen desaturation events during controlled hypotensive anesthesia
Time frame: Intraoperatively, from induction of anesthesia until extubation
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 13 Apr 2025.
- Background: PubMed 39979813Li X, Zheng Y, Zhang J. Cerebral oxygenation and hemodynamic changes during ephedrine and phenylephrine administration for transient intraoperative hypotension in patients undergoing major abdominal surgery: a randomized controlled trial. BMC Anesthesiol. 2025 Feb 20;25(1):87. doi: 10.1186/s12871-025-02944-z.
- Background: PubMed 39952888Hsiao YC, Chang YT, Cheng CS, Lien KH. Dexmedetomidine infusion on blood loss in orthognathic surgery: A retrospective study on its efficacy. J Formos Med Assoc. 2026 Apr;125(4):387-390. doi: 10.1016/j.jfma.2025.02.009. Epub 2025 Feb 13. No abstract available.
- Background: PubMed 40102081Ravelo V, Olate S, Bravo-Soto G, Zaror C, Mommaerts M. Systematic review of soft-to-hard tissue ratios in orthognathic surgery: 3D analysis-update of scientific evidence. Int J Oral Maxillofac Surg. 2025 Sep;54(9):819-829. doi: 10.1016/j.ijom.2025.02.008. Epub 2025 Mar 17.
- Individual participant dataSharing planned: No
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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 Cognitive Dysfunction and Postoperative Complications, run by Medipol 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 1 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: finished, as of the sponsor's last update on 13 Apr 2025. 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?
Change in cognitive function measured by Mini-Mental State Examination (MMSE) scores (time frame: Baseline (7 days before surgery), postoperative 10th day, 1st month, and 3rd month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06925711, which also lists 3 linked publications.
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 13 Apr 2025.