Hypotension During SurgeryPhase 4NCT04908553
Study on the Safety and Effectiveness of Remimazolam Tosilate for Injection for Short-term Elective Surgery in Adults
A Phase 4 study testing Remimazolam Tosilate for Injection 0.1mg/kg, Remimazolam Tosilate for Injection 0.15mg/kg and Remimazolam Tosilate for Injection 0.2mg/kg in people with Hypotension During Surgery, run by Tongji Hospital at 1 site in China.
Trial summary
Research objective: To explore the safety and dose exploration of Remimazolam Tosilate for Injection for induction and maintenance of general anesthesia in elective short-term surgery in adults. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypotension During Surgery
- What is being tested?
- Remimazolam Tosilate for Injection 0.1mg/kg, Remimazolam Tosilate for Injection 0.15mg/kg and Remimazolam Tosilate for Injection 0.2mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 31 May 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA Ⅰ-Ⅲ grade;
- age 18-65 years old;
- gender is not limited;
- planned elective support laryngoscope surgery (glottic polypectomy under support laryngoscope, epiglottic cyst excision under support laryngoscope, benign laryngeal under support laryngoscope Lesion resection), endoscopic septoplasty, endoscopic tympanoplasty, endoscopic middle ear tube insertion, nasopharyngoplasty, head and neck benign mass resection for general anesthesia intubation patients;
- operation time No more than 90min.
Who cannot join
- Emergency surgery;
- abnormal renal function (urea nitrogen ≥1.5×ULN, blood creatinine greater than the upper limit of normal);
- abnormal liver function;
- hypovolemia, shock or coma;
- suffering from mental illness and long-term use of psychotropic drugs;
- cognition Dysfunction;
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- those who are allergic to or contraindicated to benzodiazepines and their drug components; pregnant or lactating female patients;
- have a history of drug dependence;
- have used other sedatives in the past week;
- have been a subject within the past 3 months Participated in drug clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Dose Exploration of Remimazolam Tosilate for Injection for Induction and Maintenance of General Anesthesia Intubation for Elective Short-term Surgery in Adults: a Multi-center, Randomized, Double-blind Clinical Study
Research objective: To explore the safety and dose exploration of Remimazolam Tosilate for Injection for induction and maintenance of general anesthesia in elective short-term surgery in adults.
Main research indicators:(1)Success rate of sedation during induction and maintenance of general anesthesia with remazolam tosylate;(2)The incidence and severity of hypotension in the induction and maintenance phases Study design: Multi-center, randomized, double-blind clinical study. Subject population: patients undergoing elective short-term surgery. Research data collection period: The subject signs the consent form until discharge or death in the hospital or withdrawal from the research.
Read more
Number of research centers/sample size: It is planned to enroll 600 patients from 11 hospitals.
Research process: The researchers will include patients who meet the enrollment criteria and agree to participate in the investigation of the support laryngoscope surgery and minor head and neck surgery patients from the elective surgery patients.
Read the detailed description
The data collected in this study is recorded by the researcher in the eCRF, including:
- Data to be collected during the screening period and before the operation: the basic characteristics of the patient and demographic data;
- Data to be recorded during and/or postoperatively: main research indicators, secondary indicators and other indicators.
- Conditions
- Hypotension During Surgery
- Being tested
- Remimazolam Tosilate for Injection 0.1mg/kg, Remimazolam Tosilate for Injection 0.15mg/kg, Remimazolam Tosilate for Injection 0.2mg/kg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam Tosilate for Injection 0.1mg/kgDrug
Also called low dose group
Remimazolam Tosilate for Injection 0.1mg/kg at induction
Remimazolam Tosilate for Injection 0.15mg/kgDrug
Also called medium dose group
Remimazolam Tosilate for Injection 0.15mg/kg at induction
Remimazolam Tosilate for Injection 0.2mg/kgDrug
Also called high dose group
Remimazolam Tosilate for Injection 0.2mg/kg at induction
| Study group | Role | What they receive |
|---|---|---|
| low dose group | Other | Remimazolam Tosilate for Injection 0.1mg/kg at induction Receives: Drug: Remimazolam Tosilate for Injection 0.1mg/kg |
| medium dose group | Other | Remimazolam Tosilate for Injection 0.15mg/kg at induction Receives: Drug: Remimazolam Tosilate for Injection 0.15mg/kg |
| high dose group | Other | Remimazolam Tosilate for Injection 0.2mg/kg at induction Receives: Drug: Remimazolam Tosilate for Injection 0.2mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypotension during the anesthesia
The systolic blood pressure during the anesthesia is ≤ 90 mmHg, or a reduction of >20% from the baseline period, or the average blood pressure is <65 mmHg
Measured: during the anesthesia procedure
The rate of Successful sedation during the anesthesia
Successful sedation during the anesthesia is defined as: 1) successful induction of anesthesia without anesthesia remedial measures during the induction period; 2) no recovery during the anesthesia maintenance period, no unexpected physical activity, and no remedial measures during the maintenance period anesthesia.
Measured: during the anesthesia procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start1 Jul 2021
- Primary completion30 Mar 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension During SurgeryStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ailin Luo, Tongji Hospital
- Investigators
- Ailin Luo, Doctor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908553
- Sponsor's protocol ID
- 2021S027
- Status last verified
- Jun 2025
- First submitted
- 21 May 2021
- Last updated
- 29 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Dose Exploration of Remimazolam Tosilate for Injection for Induction and Maintenance of General Anesthesia Intubation for Elective Short-term Surgery in Adults: a Multi-center, Randomized, Double-blind Clinical Study
- ClinicalTrials.gov ID
- NCT04908553
- Acronym / sponsor ID
- 2021S027
- Conditions
- Hypotension During Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 1 Jun 2021 (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.
Research objective: To explore the safety and dose exploration of Remimazolam Tosilate for Injection for induction and maintenance of general anesthesia in elective short-term surgery in adults.
Main research indicators:(1)Success rate of sedation during induction and maintenance of general anesthesia with remazolam tosylate;(2)The incidence and severity of hypotension in the induction and maintenance phases Study design: Multi-center, randomized, double-blind clinical study. Subject population: patients undergoing elective short-term surgery. Research data collection period: The subject signs the consent form until discharge or death in the hospital or withdrawal from the research.
Number of research centers/sample size: It is planned to enroll 600 patients from 11 hospitals.
Research process: The researchers will include patients who meet the enrollment criteria and agree to participate in the investigation of the support laryngoscope surgery and minor head and neck surgery patients from the elective surgery patients.
Detailed description
The data collected in this study is recorded by the researcher in the eCRF, including:
- Data to be collected during the screening period and before the operation: the basic characteristics of the patient and demographic data;
- Data to be recorded during and/or postoperatively: main research indicators, secondary indicators and other indicators.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low dose group | Other | Drug: Remimazolam Tosilate for Injection 0.1mg/kgRemimazolam Tosilate for Injection 0.1mg/kg at induction |
| medium dose group | Other | Drug: Remimazolam Tosilate for Injection 0.15mg/kgRemimazolam Tosilate for Injection 0.15mg/kg at induction |
| high dose group | Other | Drug: Remimazolam Tosilate for Injection 0.2mg/kgRemimazolam Tosilate for Injection 0.2mg/kg at induction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ASA Ⅰ-Ⅲ grade;
- age 18-65 years old;
- gender is not limited;
- planned elective support laryngoscope surgery (glottic polypectomy under support laryngoscope, epiglottic cyst excision under support laryngoscope, benign laryngeal under support laryngoscope Lesion resection), endoscopic septoplasty, endoscopic tympanoplasty, endoscopic middle ear tube insertion, nasopharyngoplasty, head and neck benign mass resection for general anesthesia intubation patients;
- operation time No more than 90min.
Key exclusion criteria (10 listed)
- Emergency surgery;
- abnormal renal function (urea nitrogen ≥1.5×ULN, blood creatinine greater than the upper limit of normal);
- abnormal liver function;
- hypovolemia, shock or coma;
- suffering from mental illness and long-term use of psychotropic drugs;
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 Tosilate for Injection 0.1mg/kgAlso: low dose groupRemimazolam Tosilate for Injection 0.1mg/kg at induction | Drug | low dose group |
| Remimazolam Tosilate for Injection 0.15mg/kgAlso: medium dose groupRemimazolam Tosilate for Injection 0.15mg/kg at induction | Drug | medium dose group |
| Remimazolam Tosilate for Injection 0.2mg/kgAlso: high dose groupRemimazolam Tosilate for Injection 0.2mg/kg at induction | Drug | high dose group |
Primary outcome
Incidence of hypotension during the anesthesia
Time frame: during the anesthesia procedure
The systolic blood pressure during the anesthesia is ≤ 90 mmHg, or a reduction of >20% from the baseline period, or the average blood pressure is <65 mmHg
The rate of Successful sedation during the anesthesia
Time frame: during the anesthesia procedure
Successful sedation during the anesthesia is defined as: 1) successful induction of anesthesia without anesthesia remedial measures during the induction period; 2) no recovery during the anesthesia maintenance period, no unexpected physical activity, and no remedial measures during the maintenance period anesthesia.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ailin Luo, Doctor principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam Tosilate for Injection 0.1mg/kg, Remimazolam Tosilate for Injection 0.15mg/kg and Remimazolam Tosilate for Injection 0.2mg/kg in people with Hypotension During Surgery, run by Tongji Hospital 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 5 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: finished, as of the sponsor's last update on 29 Jun 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 hypotension during the anesthesia (time frame: during the anesthesia procedure). 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 29 Jun 2025.