Идёт набор NCT07439679

Preoperative Anxiety and Its Impact on Intraoperative Hemodynamics and Postoperative Pain, Edema, and Trismus in Orthognathic Surgery

— Наблюдательное Dentofacial Deformities

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Dentofacial Deformities. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Turkey (Türkiye)
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Effect of Preoperative Anxiety Levels on Intraoperative Hemodynamic Parameters and Postoperative Edema, Pain, and Trismus in Patients Undergoing Bimaxillary Orthognathic Surgery: A Prospective Observational Study

Обзор

This study aims to investigate the relationship between preoperative anxiety and intraoperative hemodynamic changes, as well as postoperative pain and facial edema, in patients undergoing orthognathic surgery. Orthognathic surgery is a corrective jaw surgery performed to treat dentofacial deformities. Although the procedure improves functional and aesthetic outcomes, patients may experience significant anxiety before surgery. Elevated anxiety levels may influence physiological responses during the operation and may affect postoperative recovery. In this study, preoperative anxiety levels will be evaluated using validated assessment scales prior to surgery. During the intraoperative period, hemodynamic parameters such as heart rate and blood pressure will be recorded. After surgery, postoperative pain and facial edema will be assessed using standardized clinical evaluation methods. The objective of this research is to determine whether higher levels of preoperative anxiety are associated with changes in intraoperative hemodynamic stability and increased postoperative discomfort. The findings may contribute to improved perioperative management strategies and enhanced patient care in orthognathic surgery.

Подробное описание

This prospective, single-center clinical study is being conducted at the Department of Oral and Maxillofacial Surgery, Istanbul Medipol University. The aim of the study is to evaluate the effect of preoperative anxiety levels on intraoperative hemodynamic parameters and postoperative facial edema, pain, and trismus in patients undergoing bimaxillary orthognathic surgery.

Patients classified as ASA I or ASA II and scheduled to undergo Le Fort I osteotomy combined with bilateral sagittal split ramus osteotomy are being included in the study. Patients with a history of previous orthognathic surgery, psychiatric disorders, systemic diseases that may affect healing, active smoking, pregnancy, or incomplete questionnaire responses are being excluded.

Preoperative anxiety levels are being assessed using the State-Trait Anxiety Inventory (STAI-I and STAI-II). Based on STAI-I scores, patients are being categorized into low-anxiety and high-anxiety groups.

During the intraoperative period, systolic arterial pressure, diastolic arterial pressure, mean arterial pressure, heart rate, and peripheral oxygen saturation are being recorded at predefined time intervals.

Postoperative evaluations are being performed at 1 hour, 1 day, 2 days, 5 days, 10 days, and 1 month after surgery. Facial edema is being measured using a three-dimensional digital facial scanning system, pain intensity is being assessed using the Visual Analog Scale (VAS), and maximum mouth opening is being measured to determine the degree of trismus.

Первичные конечные точки

Postoperative Facial Edema [Срок оценки: Postoperative 1 hour to 1 month]

Вторичные конечные точки (7)

Postoperative Pain (VAS) [Срок оценки: Postoperative 1 hour to 1 month]
Maximum Mouth Opening (Trismus) [Срок оценки: Postoperative 1 hour to 1 month]
Systolic Blood Pressure [Срок оценки: Intraoperative period]
Diastolic Blood Pressure [Срок оценки: Intraoperative period (from induction of anesthesia to completion of surgery)]
Mean Arterial Pressure [Срок оценки: Intraoperative period (from induction of anesthesia to completion of surgery)]
Heart Rate [Срок оценки: Intraoperative period (from induction of anesthesia to completion of surgery)]
Peripheral Oxygen Saturation (SpO2) [Срок оценки: Intraoperative period (from induction of anesthesia to completion of surgery)]

Критерии участия

Критерии включения

ASA physical status I or II
Patients scheduled for bimaxillary orthognathic surgery (Le Fort I osteotomy and bilateral sagittal split ramus osteotomy)
Ability to understand and complete the STAI questionnaire
Provision of written informed consent