A Randomized, Single-blind, Parallel-controlled Clinical Study to Evaluate the Safety and Efficacy of Remimazolam Besylate Combined With Alfentanil in Anesthesia for Thoracic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Incidence of Intraoperative Hypoxemia
研究概览
简要总结
Title: A Clinical Study Comparing Two Anesthesia Methods for Chest Surgery
Why is this study being done? Chest surgeries (like lung surgery) require safe and stable anesthesia. Currently, a drug called propofol combined with an opioid painkiller (alfentanil) is commonly used. However, propofol can sometimes cause low blood pressure and low oxygen levels. A newer drug called remimazolam may cause fewer of these side effects. This study aims to compare the safety and effectiveness of remimazolam (combined with alfentanil) versus propofol (combined with alfentanil) for anesthesia during chest surgery.
What will happen in the study?
Patients scheduled for elective chest surgery will be invited to participate. If they agree, they will be randomly assigned (like flipping a coin) to one of two groups:
- Group 1: Will receive remimazolam and alfentanil for anesthesia.
- Group 2: Will receive propofol and alfentanil for anesthesia (standard care).
The anesthesiologist will carefully monitor patients during and after surgery. We will mainly compare how often patients in each group experience two safety issues: low oxygen levels in the blood and low blood pressure. We will also record recovery times, drug doses, side effects, and ask patients and surgeons about their satisfaction.
Who can participate? Adults aged 18-65 who are scheduled for elective chest surgery and are in relatively stable health (ASA physical status I-III).
Where is the study taking place? This study will be conducted in the Department of Anesthesiology at The First Affiliated Hospital of Xinxiang Medical College, Henan, China.
Ethics Approval:
This study has been reviewed and approved by the Ethics Committee of The First Affiliated Hospital of Xinxiang Medical College (Approval Number: (2025) Medical Ethics Committee Approval No. 29).
详细描述
Study Design:
This is a prospective, randomized, single-blind, parallel-group, controlled clinical trial. It is designed as a Phase IV study comparing the clinical profiles of two established anesthetic regimens.
Background and Rationale:
Thoracic surgery, particularly procedures requiring one-lung ventilation, poses significant challenges for anesthetic management, demanding excellent hemodynamic stability and respiratory control. Propofol, while a mainstay for total intravenous anesthesia, is associated with dose-dependent hypotension and respiratory depression. Remimazolam, a novel ultrashort-acting benzodiazepine, is metabolized by tissue esterases and may offer a more stable hemodynamic profile. Combining it with the short-acting opioid alfentanil could provide an effective and potentially safer alternative for thoracic anesthesia. This study seeks to generate high-level evidence comparing these two combinations in a surgical setting known for its physiological demands.
Intervention Protocol:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This is a single-blind study. Participants (patients) and the research personnel responsible for outcome assessment (e.g., collecting postoperative recovery data, evaluating complications) will be blinded to group assignment.
The anesthesiologists administering the anesthetic drugs cannot be blinded due to the clinical requirements for drug titration and patient safety management.
To minimize potential bias, all syringes and infusion lines will be covered with opaque labels to conceal the study drug's appearance from the participant and assessment staff. Standardized anesthesia and surgical protocols will be strictly followed.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective thoracic surgery (e.g., pulmonary lobectomy, esophagectomy) under general anesthesia with preserved spontaneous respiration.
- •American Society of Anesthesiologists (ASA) physical status class I-III.
- •Age between 18 and 75 years.
- •Provide written informed consent.
排除标准
- •Severe hepatic or renal dysfunction (e.g., Child-Pugh class C, eGFR < 30 mL/min/1.73m²).
- •Severe respiratory dysfunction (e.g., COPD GOLD stage 3-4, severe asthma).
- •Anticipated difficult airway (e.g., Mallampati class IV, history of difficult intubation).
- •Known allergy or hypersensitivity to benzodiazepines, opioids, or propofol.
- •Pregnancy or lactation.
- •Participation in another interventional clinical trial within the past 3 months.
- •Mental illness or inability to cooperate with assessments.
研究组 & 干预措施
Remimazolam Besylate + Alfentanil
Patients will receive total intravenous anesthesia induced and maintained with Remimazolam Besylate in combination with Alfentanil.
干预措施: Propofol (Drug)
Remimazolam Besylate + Alfentanil
Patients will receive total intravenous anesthesia induced and maintained with Remimazolam Besylate in combination with Alfentanil.
干预措施: Alfentanil Hydrochloride Injection (Drug)
Propofol + Alfentanil
Patients will receive total intravenous anesthesia induced and maintained with Propofol in combination with Alfentanil (standard care).
干预措施: Remimazolam Besylate for Injection (Drug)
Propofol + Alfentanil
Patients will receive total intravenous anesthesia induced and maintained with Propofol in combination with Alfentanil (standard care).
干预措施: Alfentanil Hydrochloride Injection (Drug)
结局指标
主要结局
Incidence of Intraoperative Hypoxemia
时间窗: From induction of anesthesia until the end of surgery.
Defined as peripheral oxygen saturation (SpO₂) \< 90% for more than 10 seconds during surgery.
Incidence of Intraoperative Hypotension
时间窗: From induction of anesthesia until the end of surgery.
Defined as mean arterial pressure (MAP) \< 65 mmHg or a decrease \>20% from baseline during surgery.
次要结局
- Need for Airway Maneuver(From induction of anesthesia until the end of surgery.)
- Time to Extubation(From induction of anesthesia until the end of surgery.)
- Incidence of Postoperative Nausea and Vomiting (PONV)(From induction of anesthesia until the end of surgery.)
- Patient Satisfaction Score(From induction of anesthesia until the end of surgery.)