Not Yet RecruitingPhase 4

A Randomized, Controlled Clinical Trial Comparing Remimazolam Besylate Combined With Alfentanil Versus Propofol Combined With Alfentanil for Anesthesia in Thoracic Surgery

50 participantsStarted 2026-03-01

Plain-language summary

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).

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion Criteria: * 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. Exclusion Criteria: * 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.

What they're measuring

Incidence of Intraoperative Hypoxemia

Timeframe: From induction of anesthesia until the end of surgery.

Incidence of Intraoperative Hypotension

Timeframe: From induction of anesthesia until the end of surgery.

Trial details

NCT IDNCT07347496

SponsorThe First Affiliated Hospital of Xinxiang Medical College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-05-31