Remimazolam BesylatePhase 1/2NCT07086911
The Impact of Remimazolam Tosilate on Oxygenation and Postoperative Cognitive Function in Elderly Patients Undergoing Thoracoscopic Lobectomy
A Phase 1/2 study testing Remimazolam and Propofol in people with Remimazolam Besylate and Thoracoscopic Lobectomy, run by Jinqiao Qian at 1 site in China.
Trial summary
Background: During thoracoscopic lobectomy in elderly patients, one-lung ventilation (OLV) is a common procedure. However, this process is prone to cause hypoxemia and postoperative cognitive dysfunction (POCD), which seriously affect the postoperative recovery and prognosis of patients. Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Remimazolam Besylate, Thoracoscopic Lobectomy, Oxygenation
- What is being tested?
- Remimazolam and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Aug 2025to Dec 2026
- Phase
- Phase 1/2
- 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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients scheduled for thoracoscopic surgery under general anesthesia at the First Affiliated Hospital of Kunming Medical University;
- Age 65 to 75 years old;
- BMI18-30 kg/m ²;
- ASA grades I to III;
- There are no contraindications to any related drugs;
- Both the patient and their family members agreed to participate in this study and signed the informed consent form
Who cannot join
- Patients with severe sinus bradycardia (heart rate <50 beats per minute) and atrioventricular block;
- Respiratory tract infection and the use of non-steroidal anti-inflammatory drugs or hormone drugs within 2 weeks before the operation;
- Those with central nervous system and psychological disorders;
- Have taken anticholinergic drugs, anticonvulsants, anti-anxiety drugs, antidepressants, etc. in the past half year;
- Severe liver and kidney dysfunction and immune system diseases, uncontrolled hypertension and diabetes;
- History of preoperative radiotherapy and chemotherapy;
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- Patients with communication barriers who are unable to cooperate to complete the test;
- The OLV < 60 min or interim thoracotomy patients;
- Intraoperative blood loss > 1500ml;
- Patients transferred to the ICU ward after the operation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Zhuoran Wang, doctor, +86 18468116284, wangzhuoranbb@163.com
ZIxian Yin, postgraduate, +86 15687730439, 3064214445@qq.com
About this study
Official title: The Impact of Tosylate Remimazolam on Oxygenation and Postoperative Cognitive Function in Elderly Patients Undergoing Thoracoscopic Lobectomy
Background: During thoracoscopic lobectomy in elderly patients, one-lung ventilation (OLV) is a common procedure. However, this process is prone to cause hypoxemia and postoperative cognitive dysfunction (POCD), which seriously affect the postoperative recovery and prognosis of patients. At present, there is still a need for further exploration and optimization of effective anesthetic drugs and regimens to improve intraoperative oxygenation and reduce the occurrence of POCD in such patients. Remimazolam besylate, as a novel anesthetic drug, has not yet had its advantages in thoracoscopic surgery in elderly patients fully clarified. This study is conducted to explore its effects on oxygenation and postoperative cognitive function in this specific surgical setting, so as to provide new references for clinical drug use and improve the perioperative management and postoperative outcomes of elderly patients.
Objective:To mainly investigate the effects of remimazolam besylate on oxygenation and intrapulmonary shunting during one-lung ventilation in elderly patients undergoing thoracoscopic surgery, as well as its impact on postoperative cognitive dysfunction.
Read more
Research Content:The research content includes the observation and evaluation of oxygenation index, shunt fraction, cognitive function status, intraoperative conditions (such as OLV duration, blood loss, etc.),hemodynamic indicators, blood gas analysis indicators, serum indicators, and postoperative recovery status (such as postoperative sedation, pain, adverse reactions, pulmonary complications, hospital stay duration, etc.) in elderly patients undergoing thoracoscopic lobectomy.
Research Methods:
Study Design: A randomized controlled study will be adopted. Case Selection: Inclusion Criteria: Patients aged 65-75 years old, with a BMI of 18-30 kg/m², ASA classification of I-III, no contraindications to related drugs, and consent from the patient and their family to participate in the study and sign the informed consent form, who are scheduled for thoracoscopic surgery under general anesthesia at the First Affiliated Hospital of Kunming Medical University from December 2024 to December 2025, will be selected. Exclusion Criteria: Patients with severe arrhythmias, preoperative respiratory tract infections, central nervous system diseases, hepatic or renal insufficiency, immune system diseases, a history of preoperative radiotherapy or chemotherapy, communication barriers, etc., will be excluded. Exclusion Criteria: Patients with OLV duration less than 60 minutes or conversion to thoracotomy, intraoperative blood loss greater than 1000 ml, and those transferred to the ICU after surgery will be excluded.
Grouping and Anesthesia Methods: Patients will be randomly divided into three groups: Remimazolam Group (R Group), Propofol Group (P Group), and Remimazolam Combined with Propofol Group (C Group), with 50 cases in each group. After anesthesia induction, the three groups will be maintained with different drugs and doses until 10 minutes before the end of the surgery, while remifentanil will be combined, and the infusion rate of the drugs will be adjusted according to the BIS value.
Data Collection: Detailed records will be kept of the patient's general information, intraoperative conditions, perioperative cardiovascular reactions, blood gas analysis indicators, serum indicators, as well as postoperative cognitive function assessment, sedation and pain assessment, adverse reactions, and complications.
Sample Size Calculation: Based on the oxygenation index at 60 minutes of OLV, which is the primary endpoint, and in combination with relevant literature and statistical requirements, the sample size for each group is calculated to be 58. Considering the dropout and withdrawal rates, the final sample size for each group is determined to be 70.
Statistical Analysis: SPSS 27.0 software will be used. Normal distribution measurement data, non-normal distribution measurement data, and count data will be analyzed using independent sample t-test, Wilcoxon rank-sum test, and chi-square test or Fisher's exact probability method, respectively. A P value less than 0.05 will be considered statistically significant.
Technical and Feasibility Assurance: Relying on the clinical resources and technical platform of the First Affiliated Hospital of Kunming Medical University, as well as the research team's proficiency in thoracic anesthesia techniques and the operation of related equipment, the smooth conduct of the study will be ensured.
Read the detailed description
This study aims to investigate the effects of remimazolam besylate on oxygenation and postoperative cognitive function in elderly patients undergoing thoracoscopic lobectomy with one-lung ventilation. This randomized controlled study selected 150 elderly patients aged 65 to 75 years, with a BMI of 18 to 30 kg/m², ASA classification of I to III, no contraindications to related drugs, and informed consent, who were scheduled for thoracoscopic surgery under general anesthesia at the First Affiliated Hospital of Kunming Medical University from December 2024 to December 2025. Patients with severe arrhythmias, preoperative respiratory tract infections, central nervous system diseases, etc., were excluded. Patients were randomly divided into three groups: Remimazolam Group (R Group), Propofol Group (P Group), and Remimazolam Combined with Propofol Group (C Group), with 50 cases in each group. After anesthesia induction, the three groups were maintained with different drugs and doses until 10 minutes before the end of the surgery, while remifentanil was combined, and the infusion rate of the drugs was adjusted according to the BIS value. The observed indicators included oxygenation index, shunt fraction, cognitive function status, intraoperative conditions, hemodynamic indicators, blood gas analysis indicators, serum indicators, and postoperative recovery status, etc. The study results showed that the remimazolam group had certain advantages in intraoperative oxygenation, a relatively lower incidence of postoperative cognitive dysfunction, and no significant increase in postoperative adverse reactions. The results of this study indicate that remimazolam besylate has certain application advantages in thoracoscopic surgery in elderly patients, can improve intraoperative oxygenation, reduce the risk of postoperative cognitive dysfunction, and provide a new reference for the selection of clinical anesthetic drugs.
- Conditions
- Remimazolam Besylate, Thoracoscopic Lobectomy, Oxygenation, Postoperative Cognitive Dysfunction
- Being tested
- Remimazolam, Propofol
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Remimazolam group (Group R) : After intubation, remimazolam was maintained at a pump rate of 1-2mg/kg/h until ten minutes before the end of the operation.
Group C (remimazolam combined with propofol): After intubation, maintain with 0.3-1 mg/kg/h of remimazolam and 3-6 mg/kg/h of propofol until 10 minutes before the end of surgery.
PropofolDrug
Propofol group (Group P) : After intubation, propofol was maintained at a pump rate of 4-10mg/kg/h until surgery ten minutes before the end.
Group C (remimazolam combined with propofol): After intubation, maintain with 0.3-1 mg/kg/h of remimazolam and 3-6 mg/kg/h of propofol until 10 minutes before the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam Group (Group R) | Experimental | After intubation, remimazolam was maintained at a pump rate of 1-2mg/kg/h until 10 minutes before the end of the operation. Receives: Drug: Remimazolam |
| Propofol group (Group P) | Active comparator | After intubation, propofol was maintained at a pump rate of 4-10mg/kg/h until 10 minutes before the end of the operation Receives: Drug: Propofol |
| Remimazolam combined with propofol group (Group C) | Experimental | After intubation, remimazolam at a dose of 0.3-1mg/kg/h and propofol at a dose of 3-6 mg/kg/h were maintained until 10 minutes before the end of the operation Receives: Drug: Remimazolam; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
(1)The oxygenation index and shunt fraction of the patients at different times;
(1) Oxygenation index and shunt fraction of patients at different times: before one-lung ventilation (T1), 30 minutes of one-lung ventilation (T2), 60 minutes of one-lung ventilation (T3).
Measured: perioperative
(2)Cognitive function situation
(2) cognitive function: POCD occurs within 7 days following surgery.
Measured: within 7days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study startAug 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Remimazolam BesylateStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Remimazolam group (Group R): After intubation, remimazolam was maintained at a pump rate of 1-2mg/kg/h until 10 minutes before the end of the surgery. Propofol group (Group P): After intubation, propofol was maintained at a pump rate of 4-10mg/kg/h until 10 minutes before the end of the surgery. Remimazolam combined with propofol group (Group C): After intubation, it was maintained at 0.3-1mg/kg/h of remimazolam +3-6 mg/kg/h of propofol until 10 minutes before the end of the operation.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinqiao Qian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jinqiao Qian, First Affiliated Hospital of Kunming Medical University
- Investigators
- Jinqiao Qian, doctor, Study director, First Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086911
- Sponsor's protocol ID
- ZKL-KY20241015-78
- Status last verified
- Jul 2025
- First submitted
- 27 Jun 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient Basic Information: Age, gender, ASA classification, BMI, surgical approach, operative side, preoperative baseline pulmonary function, etc. Intraoperative Conditions: Duration of one-lung ventilation (OLV), blood loss, volume of fluid infusion, remimazolam dosage, propofol dosage, remifentanil dosage, urine output, ephedrine dosage, atropine dosage, incidence of hypoxemia, etc. Perioperative Cardiovascular Response: Heart rate (HR), mean arterial pressure (MAP), pulse oxygen saturation (SpO₂) recorded at the following time points: upon entering the operating room (T0), before OLV initiation (T1), 30 minutes after OLV initiation (T2), 60 minutes after OLV initiation (T3), before extubation (T4), and 5 minutes after extubation (T5). Blood Gas Analysis Indicators:Arterial and central venous blood gas analyses were performed on all patients at T1 (before OLV), T2 (30 min after OLV), and T3 (60 min after OLV). Recorded parameters included: airway plateau pressure (Pplat)and so on.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Tosylate Remimazolam on Oxygenation and Postoperative Cognitive Function in Elderly Patients Undergoing Thoracoscopic Lobectomy
- ClinicalTrials.gov ID
- NCT07086911
- Acronym / sponsor ID
- ZKL-KY20241015-78
- Conditions
- Remimazolam Besylate, Thoracoscopic Lobectomy, Oxygenation, Postoperative Cognitive Dysfunction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Jinqiao QianUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Jul 2025 (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.
Background: During thoracoscopic lobectomy in elderly patients, one-lung ventilation (OLV) is a common procedure. However, this process is prone to cause hypoxemia and postoperative cognitive dysfunction (POCD), which seriously affect the postoperative recovery and prognosis of patients. At present, there is still a need for further exploration and optimization of effective anesthetic drugs and regimens to improve intraoperative oxygenation and reduce the occurrence of POCD in such patients. Remimazolam besylate, as a novel anesthetic drug, has not yet had its advantages in thoracoscopic surgery in elderly patients fully clarified. This study is conducted to explore its effects on oxygenation and postoperative cognitive function in this specific surgical setting, so as to provide new references for clinical drug use and improve the perioperative management and postoperative outcomes of elderly patients.
Objective:To mainly investigate the effects of remimazolam besylate on oxygenation and intrapulmonary shunting during one-lung ventilation in elderly patients undergoing thoracoscopic surgery, as well as its impact on postoperative cognitive dysfunction.
Research Content:The research content includes the observation and evaluation of oxygenation index, shunt fraction, cognitive function status, intraoperative conditions (such as OLV duration, blood loss, etc.),hemodynamic indicators, blood gas analysis indicators, serum indicators, and postoperative recovery status (such as postoperative sedation, pain, adverse reactions, pulmonary complications, hospital stay duration, etc.) in elderly patients undergoing thoracoscopic lobectomy.
Research Methods:
Study Design: A randomized controlled study will be adopted. Case Selection: Inclusion Criteria: Patients aged 65-75 years old, with a BMI of 18-30 kg/m², ASA classification of I-III, no contraindications to related drugs, and consent from the patient and their family to participate in the study and sign the informed consent form, who are scheduled for thoracoscopic surgery under general anesthesia at the First Affiliated Hospital of Kunming Medical University from December 2024 to December 2025, will be selected. Exclusion Criteria: Patients with severe arrhythmias, preoperative respiratory tract infections, central nervous system diseases, hepatic or renal insufficiency, immune system diseases, a history of preoperative radiotherapy or chemotherapy, communication barriers, etc., will be excluded. Exclusion Criteria: Patients with OLV duration less than 60 minutes or conversion to thoracotomy, intraoperative blood loss greater than 1000 ml, and those transferred to the ICU after surgery will be excluded.
Grouping and Anesthesia Methods: Patients will be randomly divided into three groups: Remimazolam Group (R Group), Propofol Group (P Group), and Remimazolam Combined with Propofol Group (C Group), with 50 cases in each group. After anesthesia induction, the three groups will be maintained with different drugs and doses until 10 minutes before the end of the surgery, while remifentanil will be combined, and the infusion rate of the drugs will be adjusted according to the BIS value.
Data Collection: Detailed records will be kept of the patient's general information, intraoperative conditions, perioperative cardiovascular reactions, blood gas analysis indicators, serum indicators, as well as postoperative cognitive function assessment, sedation and pain assessment, adverse reactions, and complications.
Sample Size Calculation: Based on the oxygenation index at 60 minutes of OLV, which is the primary endpoint, and in combination with relevant literature and statistical requirements, the sample size for each group is calculated to be 58. Considering the dropout and withdrawal rates, the final sample size for each group is determined to be 70.
Statistical Analysis: SPSS 27.0 software will be used. Normal distribution measurement data, non-normal distribution measurement data, and count data will be analyzed using independent sample t-test, Wilcoxon rank-sum test, and chi-square test or Fisher's exact probability method, respectively. A P value less than 0.05 will be considered statistically significant.
Technical and Feasibility Assurance: Relying on the clinical resources and technical platform of the First Affiliated Hospital of Kunming Medical University, as well as the research team's proficiency in thoracic anesthesia techniques and the operation of related equipment, the smooth conduct of the study will be ensured.
Detailed description
This study aims to investigate the effects of remimazolam besylate on oxygenation and postoperative cognitive function in elderly patients undergoing thoracoscopic lobectomy with one-lung ventilation. This randomized controlled study selected 150 elderly patients aged 65 to 75 years, with a BMI of 18 to 30 kg/m², ASA classification of I to III, no contraindications to related drugs, and informed consent, who were scheduled for thoracoscopic surgery under general anesthesia at the First Affiliated Hospital of Kunming Medical University from December 2024 to December 2025. Patients with severe arrhythmias, preoperative respiratory tract infections, central nervous system diseases, etc., were excluded. Patients were randomly divided into three groups: Remimazolam Group (R Group), Propofol Group (P Group), and Remimazolam Combined with Propofol Group (C Group), with 50 cases in each group. After anesthesia induction, the three groups were maintained with different drugs and doses until 10 minutes before the end of the surgery, while remifentanil was combined, and the infusion rate of the drugs was adjusted according to the BIS value. The observed indicators included oxygenation index, shunt fraction, cognitive function status, intraoperative conditions, hemodynamic indicators, blood gas analysis indicators, serum indicators, and postoperative recovery status, etc. The study results showed that the remimazolam group had certain advantages in intraoperative oxygenation, a relatively lower incidence of postoperative cognitive dysfunction, and no significant increase in postoperative adverse reactions. The results of this study indicate that remimazolam besylate has certain application advantages in thoracoscopic surgery in elderly patients, can improve intraoperative oxygenation, reduce the risk of postoperative cognitive dysfunction, and provide a new reference for the selection of clinical anesthetic drugs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Remimazolam group (Group R): After intubation, remimazolam was maintained at a pump rate of 1-2mg/kg/h until 10 minutes before the end of the surgery. Propofol group (Group P): After intubation, propofol was maintained at a pump rate of 4-10mg/kg/h until 10 minutes before the end of the surgery. Remimazolam combined with propofol group (Group C): After intubation, it was maintained at 0.3-1mg/kg/h of remimazolam +3-6 mg/kg/h of propofol until 10 minutes before the end of the operation.
| Arm | Type | Receives |
|---|---|---|
| Remimazolam Group (Group R) | Experimental | Drug: RemimazolamAfter intubation, remimazolam was maintained at a pump rate of 1-2mg/kg/h until 10 minutes before the end of the operation. |
| Propofol group (Group P) | Active comparator | Drug: PropofolAfter intubation, propofol was maintained at a pump rate of 4-10mg/kg/h until 10 minutes before the end of the operation |
| Remimazolam combined with propofol group (Group C) | Experimental | Drug: Remimazolam, Drug: PropofolAfter intubation, remimazolam at a dose of 0.3-1mg/kg/h and propofol at a dose of 3-6 mg/kg/h were maintained until 10 minutes before the end of the operation |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Patients scheduled for thoracoscopic surgery under general anesthesia at the First Affiliated Hospital of Kunming Medical University;
- Age 65 to 75 years old;
- BMI18-30 kg/m ²;
- ASA grades I to III;
- There are no contraindications to any related drugs;
Key exclusion criteria (10 listed)
- Patients with severe sinus bradycardia (heart rate <50 beats per minute) and atrioventricular block;
- Respiratory tract infection and the use of non-steroidal anti-inflammatory drugs or hormone drugs within 2 weeks before the operation;
- Those with central nervous system and psychological disorders;
- Have taken anticholinergic drugs, anticonvulsants, anti-anxiety drugs, antidepressants, etc. in the past half year;
- Severe liver and kidney dysfunction and immune system diseases, uncontrolled hypertension and diabetes;
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 |
|---|---|---|
| RemimazolamRemimazolam group (Group R) : After intubation, remimazolam was maintained at a pump rate of 1-2mg/kg/h until ten minutes before the end of the operation. Group C (remimazolam combined with propofol): After intubation, maintain with 0.3-1 mg/kg/h of remimazolam and 3-6 mg/kg/h of propofol until 10 minutes before the end of surgery. | Drug | Remimazolam Group (Group R), Remimazolam combined with propofol group (Group C) |
| PropofolPropofol group (Group P) : After intubation, propofol was maintained at a pump rate of 4-10mg/kg/h until surgery ten minutes before the end. Group C (remimazolam combined with propofol): After intubation, maintain with 0.3-1 mg/kg/h of remimazolam and 3-6 mg/kg/h of propofol until 10 minutes before the end of surgery. | Drug | Propofol group (Group P), Remimazolam combined with propofol group (Group C) |
Primary outcome
(1)The oxygenation index and shunt fraction of the patients at different times;
Time frame: perioperative
(1) Oxygenation index and shunt fraction of patients at different times: before one-lung ventilation (T1), 30 minutes of one-lung ventilation (T2), 60 minutes of one-lung ventilation (T3).
(2)Cognitive function situation
Time frame: within 7days following surgery
(2) cognitive function: POCD occurs within 7 days following 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 25 Jul 2025.
- Individual participant dataSharing planned: Yes. Patient Basic Information: Age, gender, ASA classification, BMI, surgical approach, operative side, preoperative baseline pulmonary function, etc. Intraoperative Conditions: Duration of one-lung ventilation (OLV), blood loss, volume of fluid infusion, remimazolam dosage, propofol dosage, remifentanil dosage, urine output, ephedrine dosage, atropine dosage, incidence of hypoxemia, etc. Perioperative Cardiovascular Response: Heart rate (HR), mean arterial pressure (MAP), pulse oxygen saturation (SpO₂) recorded at the following time points: upon entering the operating room (T0), before OLV initiation (T1), 30 minutes after OLV initiation (T2), 60 minutes after OLV initiation (T3), before extubation (T4), and 5 minutes after extubation (T5). Blood Gas Analysis Indicators:Arterial and central venous blood gas analyses were performed on all patients at T1 (before OLV), T2 (30 min after OLV), and T3 (60 min after OLV). Recorded parameters included: airway plateau pressure (Pplat)and so on.
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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.
Jinqiao Qian, doctor study director
First Affiliated Hospital of Kunming Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Remimazolam and Propofol in people with Remimazolam Besylate and Thoracoscopic Lobectomy, run by Jinqiao Qian at 1 site in China.
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 6 inclusion and 10 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 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Zhuoran Wang, doctor (+86 18468116284, wangzhuoranbb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(1)The oxygenation index and shunt fraction of the patients at different times; (time frame: perioperative). 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 25 Jul 2025.