Thoracic SurgeryPhase 4RAA-TSNCT07347496
A Randomized, Controlled Clinical Trial Comparing Remimazolam Besylate Combined With Alfentanil Versus Propofol Combined With Alfentanil for Anesthesia in Thoracic Surgery
A Phase 4 study testing Remimazolam Besylate for Injection, Propofol and Alfentanil Hydrochloride Injection in people with Thoracic Surgery and Anesthesia, run by The First Affiliated Hospital of Xinxiang Medical College.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thoracic Surgery, Anesthesia, Non-intubated Anesthesia
- What is being tested?
- Remimazolam Besylate for Injection, Propofol and Alfentanil Hydrochloride Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 31 May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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
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.
Read more
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).
Read the detailed description
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:
- Premedication \& Induction: All patients will receive standardized premedication. Anesthesia induction will begin with alfentanil (10 μg/kg), followed by the study drug: either Remimazolam Besylate (0.3 mg/kg) or Propofol (1.5-2 mg/kg).
- Maintenance: Anesthesia will be maintained via continuous infusion of the assigned study drug (Remimazolam: 0.2-1 mg/kg/h; Propofol: 2-6 mg/kg/h) along with alfentanil (0-1 μg/kg/min), titrated to maintain a Bispectral Index (BIS) value between 40-60.
- Standardization: All patients will undergo standardized monitoring, airway management, and surgical and analgesic protocols as per institutional guidelines for thoracic surgery.
Primary Objectives:
To compare the incidence of intraoperative hypoxemia (SpO₂ < 90% for >10 seconds) and intraoperative hypotension (MAP < 65 mmHg or a decrease >20% from baseline) between the two groups.
Key Secondary Objectives:
Include comparison of: hemodynamic variables, need for rescue interventions, times to extubation and recovery, total drug consumption, incidence of postoperative nausea/vomiting (PONV), postoperative pulmonary complications, quality of recovery (QoR-15), and satisfaction scores from patients and surgeons.
Statistical Analysis:
Data will be analyzed based on the Intention-to-Treat principle. Categorical data will be compared using Chi-square or Fisher's exact test. Continuous data will be analyzed using Student's t-test or Mann-Whitney U test, as appropriate. Subgroup analyses are planned for specific patient populations.
- Conditions
- Thoracic Surgery, Anesthesia, Non-intubated Anesthesia
- Being tested
- Remimazolam Besylate for Injection, Propofol, Alfentanil Hydrochloride Injection
- Keywords
- Remimazolam, Alfentanil, Propofol, Non-intubated, Tubeless Anesthesia, Spontaneous Ventilation Spontaneous Ventilation, Total Intravenous Anesthesia Total Intravenous Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam Besylate for InjectionDrug
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.
PropofolDrug
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.
Alfentanil Hydrochloride InjectionDrug
A short-acting opioid analgesic. Administered at induction (10 μg/kg) and as a continuous infusion (0-1 μg/kg/min) for intraoperative analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam Besylate + Alfentanil | Experimental | Patients will receive total intravenous anesthesia induced and maintained with Remimazolam Besylate in combination with Alfentanil. Receives: 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). Receives: Drug: Remimazolam Besylate for Injection; Drug: Alfentanil Hydrochloride Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Intraoperative Hypoxemia
Defined as peripheral oxygen saturation (SpO₂) < 90% for more than 10 seconds during surgery.
Measured: 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.
Measured: From induction of anesthesia until the end of surgery.
Secondary outcomes (4)
Need for Airway Maneuver
Measured: From induction of anesthesia until the end of surgery.
Time to Extubation
Measured: From induction of anesthesia until the end of surgery.
Incidence of Postoperative Nausea and Vomiting (PONV)
Measured: From induction of anesthesia until the end of surgery.
Patient Satisfaction Score
Measured: From induction of anesthesia until the end of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347496
- Sponsor's protocol ID
- HNMU-RAA-TS-2026-001
- Acronym
- RAA-TS
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07347496
- Acronym / sponsor ID
- RAA-TS / HNMU-RAA-TS-2026-001
- Conditions
- Thoracic Surgery, Anesthesia, Non-intubated Anesthesia
- Keywords
- Remimazolam, Alfentanil, Propofol, Non-intubated, Tubeless Anesthesia, Spontaneous Ventilation Spontaneous Ventilation, Total Intravenous Anesthesia Total Intravenous Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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:
- Premedication \& Induction: All patients will receive standardized premedication. Anesthesia induction will begin with alfentanil (10 μg/kg), followed by the study drug: either Remimazolam Besylate (0.3 mg/kg) or Propofol (1.5-2 mg/kg).
- Maintenance: Anesthesia will be maintained via continuous infusion of the assigned study drug (Remimazolam: 0.2-1 mg/kg/h; Propofol: 2-6 mg/kg/h) along with alfentanil (0-1 μg/kg/min), titrated to maintain a Bispectral Index (BIS) value between 40-60.
- Standardization: All patients will undergo standardized monitoring, airway management, and surgical and analgesic protocols as per institutional guidelines for thoracic surgery.
Primary Objectives:
To compare the incidence of intraoperative hypoxemia (SpO₂ < 90% for >10 seconds) and intraoperative hypotension (MAP < 65 mmHg or a decrease >20% from baseline) between the two groups.
Key Secondary Objectives:
Include comparison of: hemodynamic variables, need for rescue interventions, times to extubation and recovery, total drug consumption, incidence of postoperative nausea/vomiting (PONV), postoperative pulmonary complications, quality of recovery (QoR-15), and satisfaction scores from patients and surgeons.
Statistical Analysis:
Data will be analyzed based on the Intention-to-Treat principle. Categorical data will be compared using Chi-square or Fisher's exact test. Continuous data will be analyzed using Student's t-test or Mann-Whitney U test, as appropriate. Subgroup analyses are planned for specific patient populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Remimazolam Besylate + Alfentanil | Experimental | Drug: Propofol, Drug: Alfentanil Hydrochloride InjectionPatients will receive total intravenous anesthesia induced and maintained with Remimazolam Besylate in combination with Alfentanil. |
| Propofol + Alfentanil | Active comparator | Drug: Remimazolam Besylate for Injection, Drug: Alfentanil Hydrochloride InjectionPatients will receive total intravenous anesthesia induced and maintained with Propofol in combination with Alfentanil (standard care). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remimazolam Besylate for InjectionA 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. | Drug | Propofol + Alfentanil |
| PropofolStandard 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 | Remimazolam Besylate + Alfentanil |
| Alfentanil Hydrochloride InjectionA short-acting opioid analgesic. Administered at induction (10 μg/kg) and as a continuous infusion (0-1 μg/kg/min) for intraoperative analgesia. | Drug | Propofol + Alfentanil, Remimazolam Besylate + Alfentanil |
Primary outcome
Incidence of Intraoperative Hypoxemia
Time frame: 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
Time frame: 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.
4 secondary outcomes
Need for Airway Maneuver
Time frame: From induction of anesthesia until the end of surgery.
Time to Extubation
Time frame: From induction of anesthesia until the end of surgery.
Incidence of Postoperative Nausea and Vomiting (PONV)
Time frame: From induction of anesthesia until the end of surgery.
Patient Satisfaction Score
Time frame: From induction of anesthesia until the end of surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam Besylate for Injection, Propofol and Alfentanil Hydrochloride Injection in people with Thoracic Surgery and Anesthesia, run by The First Affiliated Hospital of Xinxiang Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Intraoperative Hypoxemia (time frame: From induction of anesthesia until the end of surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.