MedTrace Logo

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

NCT07347496 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-01-16

No results posted yet for this study

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

  • Thoracic Surgery
  • Anesthesia
  • Non-intubated Anesthesia

Interventions

DRUG

Propofol

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.

DRUG

Alfentanil Hydrochloride Injection

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

DRUG

Remimazolam Besylate for Injection

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Xinxiang Medical College

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2028-05-31
Completion
2028-05-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07347496 on ClinicalTrials.gov