Evaluation of Perioperative Anesthesia Effectiveness in Hysteroscopy Cases Administered With Target-Controlled Infusion (TCI)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Incidence of Intraoperative Complications
研究概览
简要总结
This prospective, randomized, observational study aims to evaluate the perioperative anesthetic efficacy of different Target-Controlled Infusion (TCI) models-specifically Minto, Schnider, and Eleveld pharmacokinetic models-in patients undergoing hysteroscopy under general anesthesia. 90 female patients will be randomized into two groups, each receiving different TCI model combinations for propofol and remifentanil. Primary outcomes include intraoperative consciousness (BIS/SEF), analgesia (ANI), tissue oxygenation (NIRS), and recovery parameters. The study seeks to identify model-specific benefits regarding patient and surgeon satisfaction, recovery time, and complication rates.
详细描述
This study aims to evaluate the perioperative anesthetic efficacy of target-controlled infusion (TCI) in hysteroscopy cases. The study will be conducted in the Gynecology and Obstetrics Operating Room located on the 9th floor of Gazi University Hospital between April 2025 and July 2025.
The study will include women aged 18-65 years who will undergo hysteroscopy and meet the criteria of ASA I-II classification, with no significant comorbidities and a BMI < 35. The study is planned in two groups, with each group consisting of 45 patients, totaling 90 participants.
In the first group, TCI protocols based on the Schnider and Minto models will be applied. The initial target concentrations for propofol and remifentanil infusion will be set at 5 µg/mL and 4 ng/mL, respectively. In the second group, the Eleveld model will be used. The propofol dose will be adjusted according to the patient's age using the Eleveld algorithm, and the remifentanil effect-site concentration will be maintained at 3 ng/mL.
Participants will be informed about the study, and those eligible and willing to participate will provide signed informed consent. Upon being brought to the operating room, intravenous access will be checked and established if not already in place. Non-invasive blood pressure, heart rate, and oxygen saturation will be monitored in accordance with ASA standards.
Following this, Masimo Root device with SedLine, NIRS, and ANI sensors will be attached to the appropriate sites on the patients, ensuring data flow. These sensors will continuously monitor the patient's level of consciousness, tissue oxygenation, and pain response.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, aged 18-65
- •Scheduled for hysteroscopy under general anesthesia
- •Signed informed consent
排除标准
- •Allergy to study drugs
- •Significant cardiac, pulmonary, neurological disease
- •Pregnancy or breastfeeding
- •Substance use disorder
结局指标
主要结局
Incidence of Intraoperative Complications
时间窗: perioperative period: from beginning of anesthesia induction to discharge from recovery room
Number of patients experiencing at least one predefined complication during anesthesia, including hypotension (MAP \<65 mmHg \>1 min), bradycardia (HR \<50 bpm), or oxygen desaturation (SpO₂ \<92%)
Total Recovery Time Until Discharge Readiness
时间窗: Up to 2 hours post-anesthesia
Time elapsed from cessation of anesthetic agents to achieving an Aldrete score ≥9
次要结局
- Incidence of Postoperative Pain(Within 30 minutes after arrival in the recovery room)
- Total Propofol Consumption(From induction to end of anesthesia)
- Total Remifentanil Consumption(From induction to end of anesthesia)
- Patient and Surgeon Satisfaction and Willingness to Repeat the Same Anesthesia Method(Patient: Within 1 hour postoperatively (before recovery room discharge) Surgeon: Immediately after surgery)
- Incidence of Postoperative Nausea and Vomiting (PONV)(Within 2 hours after anesthesia discontinuation)