Comparison of the Effects of Target-Controlled Infusion Method and Manual Propofol Administration on Respiratory Function, Recovery, and Electroencephalogram in Endoscopic Submucosal Dissection Cases

Обзор

Endoscopic submucosal dissection (ESD) has become widely used as a minimally invasive alternative for the resection of early-stage gastrointestinal neoplasms. Due to the lengthy procedure time and intense pain caused by stretching, cutting, and dissecting the gastric wall during ESD, a deeper level of sedation is recommended compared to traditional endoscopic procedures (1). While ensuring adequate patient immobilisation during ESD, preserving respiratory function and rapid recovery are important clinical goals. Total intravenous anaesthesia (TIVA) is an alternative method to inhalation anaesthesia, achieved through the combination of agents such as propofol and remifentanil. TIVA applications can be performed using manual or target-controlled infusion (TCI) systems. TCI systems aim to achieve and maintain the targeted plasma or effect site concentration based on pharmacokinetic models. These systems have been shown to provide advantages such as more stable depth of sedation during endoscopy, less haemodynamic fluctuation, and faster recovery (2-4). Preserving spontaneous breathing is preferred during ESD procedures, which requires careful monitoring of respiration. The Capnostream® device records four variables (SpO₂, RR, non-invasive EtCO₂, heart rate) every 30 seconds via a nasal cannula and integrates them into a single, dimensionless value called the integrated pulmonary index (IPI). The IPI can range from 1 to 10, with 4 and below requiring intervention and 8 to 10 representing the normal range. Furthermore, the use of the bispectral index (BIS) enables objective monitoring of anaesthesia depth by analysing EEG waves and can increase the safety of the recovery process (5). This study aims to compare the effects of manual TIVA and TCI applications on recovery time, BIS, and respiratory parameters during ESD procedures in the stomach or colon region performed under sedation in the endoscopy unit. The findings will contribute to the safer and more effective planning of sedation applications. References; 1. Sasaki T, Tanabe S, Azuma M, Sato A, Naruke A, Ishido K, et al. Propofol sedation with bispectral index monitoring is useful for endoscopic submucosal dissection: a randomised prospective phase II clinical trial. Endoscopy. 2012 Jun;44(6):584-9. 2. Chang YT, Tsai TC, Hsu H, Chen YM, Chi KP, Peng SY. Sedation for gastrointestinal endoscopy with the application of target-controlled infusion. Turk J Gastroenterol Off J Turk Soc Gastroenterol. 2015 Sep;26(5):417-22. 3. Sarraj R, Theiler L, Vakilzadeh N, Krupka N, Wiest R. Propofol sedation in routine endoscopy: A case series comparing target controlled infusion vs manually controlled bolus concept. World J Gastrointest Endosc. 2024 Jan 16;16(1):11-7. 4. García Guzzo ME, Fernandez MS, Sanchez Novas D, Salgado SS, Terrasa SA, Domenech G, et al. Deep sedation using propofol target-controlled infusion for gastrointestinal endoscopic procedures: a retrospective cohort study. BMC Anaesthesiol. 10 August 2020;20(1):195. 5. Sandler NA, Hodges J, Sabino M. Assessment of recovery in patients undergoing intravenous conscious sedation using bispectral analysis. J Oral Maxillofac Surg Off J Am Assoc Oral Maxillofac Surg. 2001 Jun;59(6):603-11; discussion 611-612. 6. Ding Y, White PF. Simplified quality of anaesthesia scoring system. Anaesthesia. 1992 Oct;47(10):906-7.

Вмешательства

• Процедура manuel propofol and target controlled infusion propofol
  This study aims to compare the effects of manual TIVA and TCI propofol administration on recovery time, BIS, and respiratory parameters during ESD procedures performed in the endoscopy unit under sedation in the stomach or colon region. The findings will contribute to the safer and more effective planning of sedation procedures.

Первичные конечные точки

• integrated pulmonary index value [Срок оценки: while the procedure continues under anaesthesia]
• total apneic attack count [Срок оценки: intraoperative time]

Вторичные конечные точки (3)

• total propofol dose (mg) [Срок оценки: end of the case]
• anaesthesia quality score(0-32) [Срок оценки: intraoperative period]
• post-operative recovery time [Срок оценки: end of the case]

Критерии участия

Критерии включения

• Age: 18-75 years old
• ASA (American Society of Anaesthesiologists) physical status class I-III
• Patients with indications for ESD
• BMI < 35 kg/m²
• Patients who are cooperative and can be monitored

Критерии исключения

• Those with cardiac or pulmonary insufficiency,
• Those with neurological diseases,
• Those with severe hepatic or renal dysfunction,
• Those with psychiatric disorders that could affect their level of consciousness,
• Those with allergies or hypersensitivity to propofol, midazolam, and fentanyl, Patients who refuse to participate in the study will not be included in this clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Скрининг

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07305857 · 2025/22/1301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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