The Effect of Hypotensive Anesthesia on Cognitive Functions in Orthognatic Surgery

NCT06925711 | Completed

• 1 other identifier: MEDIPOLU-6143
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cognitive Dysfunction; Postoperative Complications

Keywords

orthognathic surgery; hypotensive anesthesia; cerebral oxygen saturation

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Intraoperatively, from induction of anesthesia until extubation

Study Arms (1)

Patients aged 18 years and older with ASA I-II scores who were diagnosed with dentofacial deformity

Device: Near-Infrared Spectroscopy (NIRS)

Interventions

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

Patients aged 18 years and older with ASA I-II scores who were diagnosed with dentofacial deformity

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients of both genders, over 18 years of age, undergoing elective Orthognathic surgery in general anesthesia.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, 34070, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 39979813 BACKGROUND

• Hsiao 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. 2025 Feb 13:S0929-6646(25)00051-8. doi: 10.1016/j.jfma.2025.02.009. Online ahead of print. No abstract available.

  PMID: 39952888 BACKGROUND

• Ravelo 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.

  PMID: 40102081 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Postoperative Complications

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 13, 2025
• Study Start: December 19, 2022
• Primary Completion: November 17, 2023
• Study Completion: February 19, 2024
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)