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

NCT07347496 | Not Yet Recruiting Phase 4

• 1 other identifier: HNMU-RAA-TS-2026-001
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Non-intubated Anesthesia; Thoracic Surgery; Anesthesia

Keywords

Remimazolam; Alfentanil; Propofol; Non-intubated; Tubeless Anesthesia; Spontaneous Ventilation Spontaneous Ventilation; Total Intravenous Anesthesia Total Intravenous Anesthesia

Outcome Measures

Primary Outcomes (2)

• Incidence of Intraoperative Hypoxemia

  Defined as peripheral oxygen saturation (SpO₂) \< 90% for more than 10 seconds during surgery.

  From induction of anesthesia until the end of surgery.

• Incidence of Intraoperative Hypotension

  Defined as mean arterial pressure (MAP) \< 65 mmHg or a decrease \>20% from baseline during surgery.

  From induction of anesthesia until the end of surgery.

Secondary Outcomes (4)

• 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.

Study Arms (2)

Remimazolam Besylate + Alfentanil

EXPERIMENTAL

Patients will receive total intravenous anesthesia induced and maintained with Remimazolam Besylate in combination with Alfentanil.

Drug: Propofol; Drug: Alfentanil Hydrochloride Injection

Propofol + Alfentanil

ACTIVE COMPARATOR

Patients will receive total intravenous anesthesia induced and maintained with Propofol in combination with Alfentanil (standard care).

Drug: Remimazolam Besylate for Injection; Drug: Alfentanil Hydrochloride Injection

Interventions

Remimazolam Besylate for Injection DRUG

A 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 + Alfentanil

Propofol DRUG

Standard 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.

Remimazolam Besylate + Alfentanil

Alfentanil Hydrochloride Injection DRUG

A short-acting opioid analgesic. Administered at induction (10 μg/kg) and as a continuous infusion (0-1 μg/kg/min) for intraoperative analgesia.

Propofol + Alfentanil; Remimazolam Besylate + Alfentanil

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xinxiang Medical College: lead

MeSH Terms

Interventions

Injections; Propofol; Alfentanil

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, single-blind, parallel-group, controlled, superiority trial. Participants will be allocated in a 1:1 ratio to receive either the experimental regimen (Remimazolam Besylate combined with Alfentanil) or the active comparator regimen (Propofol combined with Alfentanil) for anesthesia maintenance during non-intubated video-assisted thoracic surgery.

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 16, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: January 16, 2026

Record last verified: 2026-01