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Clinical Trials/NCT06238973
NCT06238973CompletedNot Applicable

Evaluation of the Relationship Between the Level of Controlled Hypotension Applied During Rhinoplasty and Septoplasty Surgery and the Incidence of Postoperative Cognitive Dysfunction and Delirium

Hitit University2 sites in 2 countries70 target enrollmentStarted: February 6, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
70
Locations
2
Primary Endpoint
Post Operative Cognitive Dysfunction with Mini Mental Test

Study Overview

Brief Summary

Controlled hypotension application is a commonly preferred anesthesia practice during surgical procedures, particularly in regions with rich tissue perfusion, aiming to reduce bleeding, enhance surgical field visibility, and mitigate potential complications. Preserving blood flow, especially to the brain, heart, and kidneys, is vital during this method. Previous studies on the subject have primarily focused on short-term effects regarding cognitive impairments, with limited research on the long-term impacts.

In our study, we aim to investigate how controlled hypotension application, administered to patients undergoing rhinoplasty or septoplasty surgery, specifically affects cerebral blood flow and its potential consequences on the development of short-term/medium-term/long-term cognitive impairments or delirium in the postoperative period.

Detailed Description

Nasal congestion is a health issue that affects approximately 70% of the general population, with nasal septal deviations being the most common cause . Various nasal septal surgeries, such as septoplasty or rhinoplasty, are performed to address aesthetic concerns related to curvature and correct deviations. The most common issue encountered during these operations is bleeding, which hinders the visibility of the surgical field. To prevent bleeding in the surgical area, the Trendelenburg position and controlled hypotension practices are frequently preferred . Controlled hypotension is defined as the intentional, elective, and controlled reduction of systolic blood pressure to 80-90 mmHg, the reduction of mean arterial pressure (MAP) to 50-65 mmHg, or a 30-50% reduction in baseline MAP.

Controlled hypotension is employed to shorten the duration of surgical procedures, reduce bleeding, decrease the need for blood transfusion, and enhance the quality of surgery by providing a satisfactory and clear surgical field without causing organ dysfunction.

Cognitive function is a mental process encompassing an individual's learning, understanding of oneself and the world, and acquired knowledge and beliefs about the surroundings. It covers higher brain functions such as consciousness, attention, learning, memory, perception, orientation, intelligence, action, emotion, imagination, problem-solving, decision-making, speech, reading, writing, and calculation. Cognitive function disorders are classified into delirium, dementia, amnestic disorder, cognitive disorder not otherwise specified, and postoperative cognitive dysfunction (POCD). POCD is a cognitive impairment that most commonly manifests with memory and concentration disturbances, diagnosable through neuropsychiatric tests. It is objectively measured cognitive decline beyond the expected duration for normal recovery from the physiological and pharmacological effects of anesthesia and surgery. POCD can persist from one day to years after surgery, increasing hospital stay and costs, affecting patients of all age groups, but more prevalent in older individuals. Early risk factors for POCD include anesthesia duration, low educational level, multiple surgical histories, postoperative infection, and respiratory complications. Late POCD, on the other hand, is only correlated with age among the identified risk factors. Bispectral index (BIS) and near-infrared spectroscopy (NIRS) monitoring are utilized in the perioperative process to prevent POCD . Studies have shown that lower BIS values in patients are associated with less development of postoperative cognitive dysfunction . The results suggest that deep anesthesia may have a protective effect by reducing cerebral metabolism and blood flow. Cerebral oxygenation monitoring has also demonstrated potential usefulness in preventing the development of postoperative cognitive dysfunction. Methods used for detecting postoperative cognitive dysfunction include direct interviews, questionnaires, mental status assessment tests, and neuropsychological tests . The most commonly used test among these is the Mini-Mental State Examination (MMSE). The MMSE, developed by Folstein and colleagues in 1975, evaluates cognitive functions and covers questions related to time and place orientation, memory and recall, attention and calculation, orientation, language, and visual structuring. A modified Mini-Mental test is used for those with no education. Both tests have a maximum score of 30, with 0-9 indicating severe cognitive impairment, 10-19 moderate cognitive impairment, 20-26 mild cognitive impairment, and 27-30 normal cognitive function.

Delirium is characterized by the acute onset, fluctuating course, and features such as disruption of cognitive functions due to organic causes, changes in the sleep-wake cycle, and decreased attention and perception . It is more common in intensive care units and the postoperative period, with advanced age being a risk factor for delirium due to the use of multiple medications and physical limitations. Various systemic illnesses and conditions related to the central nervous system can lead to delirium.

"Delirium, as it exhibits fluctuation throughout the day, is not always easily recognizable, and since only a medical professional can apply DSM criteria, the diagnosis may be overlooked. Screening and diagnostic tools have been developed to be easily and quickly applied using DSM criteria, allowing not only physicians but also nurses and healthcare personnel to use them.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • who will undergo rhinoplasty or septoplasty surgery
  • between the ages of 18-65
  • classified as ASA class I-II

Exclusion Criteria

  • Patients with hypertension
  • Patients with diabetes mellitus
  • Patients with significant cardiac disease
  • Patients with vascular disease with lung, kidney, or liver parenchymal diseases
  • Patients with a history of cerebrovascular events
  • Patients with hypovolemia
  • those for whom perioperative controlled hypotension is contraindicated (including emergency surgeries, patients with bleeding diathesis, and those with heart valve disease)

Outcomes

Primary Outcomes

Post Operative Cognitive Dysfunction with Mini Mental Test

Time Frame: 24 hours

The assessment of patients' postoperative cognitive function will be conducted initially 24 hours after the surgery, and subsequently on the 7th day and at the 3rd month.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Hitit University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Selcuk KAYIR

Assossiated Professor

Hitit University

Study Sites (2)

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