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临床试验/NCT07305857
NCT07305857尚未招募不适用

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

Marmara University Pendik Training and Research Hospital0 个研究点目标入组 50 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
主要终点
integrated pulmonary index value

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

integrated pulmonary index value

时间窗: while the procedure continues under anaesthesia

Integrated pulmonary index values on the capnostream device

total apneic attack count

时间窗: intraoperative time

Number of apnoeic periods developing as a result of respiratory depression during the procedure

次要结局

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

研究者

发起方
Marmara University Pendik Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

dilara gocmen

Dilara Göçmen

Marmara University Pendik Training and Research Hospital

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