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).
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.
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.
Parallel
Remimazolam Besylate for Injection
DrugA novel ultra-short-acting benzodiazepine. Induction dose: 0.3 mg/kg. Maintenance: continuous infusion at 0.2-1 mg/kg/h, titrated to maintain a BIS value between 40-60.
Propofol
DrugStandard intravenous anesthetic. Induction dose: 1.5-2 mg/kg. Maintenance: continuous infusion at 2-6 mg/kg/h, titrated to maintain a BIS value between 40-60.
Alfentanil Hydrochloride Injection
DrugA short-acting opioid analgesic. Administered at induction (10 μg/kg) and as a continuous infusion (0-1 μg/kg/min) for intraoperative analgesia.
Incidence of Intraoperative Hypoxemia
Defined as peripheral oxygen saturation (SpO₂) \< 90% for more than 10 seconds during surgery.
Incidence of Intraoperative Hypotension
Defined as mean arterial pressure (MAP) \< 65 mmHg or a decrease \>20% from baseline during surgery.
Need for Airway Maneuver
Time to Extubation
Incidence of Postoperative Nausea and Vomiting (PONV)
Patient Satisfaction Score
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