Hemodynamic InstabilityPhase 4NCT06565715
Effect of Remazolam on Hemodynamics During Hepatectomy
A Phase 4 study testing Remimazolam and Propofol in people with Hemodynamic Instability, run by Jun Zhang at 1 site in China.
Trial summary
There is high incidence of hemodynamic instability in patients undergoing hepatectomy with low central venous pressure, especially in general anesthesia combined with epidural anesthesia. Remazolam, a new benzodiazepine, has no significant cardiovascular inhibitory effect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- Remimazolam and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2024to 8 Nov 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who sign informed consent and are willing to complete the study according to the plan;
- Over 18 years of age;
- ASA grade Ⅰ ~ Ⅲ;
- Elective surgery;
- General anesthesia combined with epidural anesthesia;
- Child Pugh is classified as Level A
Who cannot join
- Abnormal coagulation function;
- Abnormal platelet;
- A history of drug dependence;
- Neurological diseases;
- Severe sinus bradycardia (HR<50 beats/min);
- Atrial fibrillation;
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- Systolic blood pressure ≥200mmHg and/or diastolic blood pressure ≥120mmHg.
- Cardiac insufficiency.
- Child Pugh is classified as B or C.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Remazolam on Hemodynamics During Hepatectomy Under General Anesthesia Combined With Thoracic Epidural Anesthesia
There is high incidence of hemodynamic instability in patients undergoing hepatectomy with low central venous pressure, especially in general anesthesia combined with epidural anesthesia. Remazolam, a new benzodiazepine, has no significant cardiovascular inhibitory effect. Investigators hypothesis that remazolam will provide better hemodynamic when compared with propofol in patients undergoing hepatectomy with general anesthesia combined with epidural anesthesia.
Read the detailed description
Investigators plan to adopt the following strategies in the clinical study of this project: (1) To compare remazolam and propofol during anesthetic induction and maintenance; (2) Remazolam group: remazolam is administered 0.3mg/kg intravenous for anesthesia induction. Propofol group: propofol is administered 2mg/kg intravenous for anesthesia induction; (3) Epidural analgesia is used during perioperative period, and remifentanil pump injection is used during the operation to assist the subjects to tolerate the tracheal catheter; (4) the haemodynamic instability score (Hemodynamic instability score) is used to comprehensively evaluate intraoperative hemodynamic status. (5) To evaluate the incidence of postoperative complications. Through the above strategies, investigators further determine the optimization effect of remazolam, a novel benzodiazepine drug, on intraoperative hemodynamics in patients undergoing low central venous pressure hepatectomy, and further lay an empirical foundation for the routine use of remazolam in clinical hepatectomy.
- Conditions
- Hemodynamic Instability
- Being tested
- Remimazolam, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Also called rebenin
Remimazolam is used for sedation during anesthetic induction and maintenance.
PropofolDrug
Also called Propofol emulsion
propofol is used for sedation during anesthetic induction and maintenance.
| Study group | Role | What they receive |
|---|---|---|
| Remazolam group | Experimental | Remazolam group: remazolam is administered 0.3mg/kg intravenous for anesthesia induction. Receives: Drug: Remimazolam |
| Propofol group | Other | Propofol group: propofol is administered 2mg/kg intravenous for anesthesia induction. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic instability score
The hemodynamic instability score is calculated as a weighted continuous measure ranging from 0 to 160 points, intended to reflect deviations of blood pressure and heart rate from predefined thresholds, and infusion rates of vasoactive agents and fluids.
Measured: intraoperative
Secondary outcomes (4)
Cardiac index （CI）
The parameter of CI is measured by advanced hemodynamic monitoring device.
Measured: intraoperative
Stroke volume variation (SVV)
The parameter of SVV is measured by advanced hemodynamic monitoring device.
Measured: intraoperative
Systemic vascular resistance index (SVRI)
The parameter of SVRI is measured by advanced hemodynamic monitoring device.
Measured: intraoperative
Complications in 1 week after surgery
Complications occured within 1 week after surgery
Measured: 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start23 Aug 2024
- Primary completion30 Oct 2024
- Study completion8 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodynamic InstabilityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jun Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jun Zhang, Fudan University
- Investigators
- Jun Zhang, Professor, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565715
- Sponsor's protocol ID
- Remazolam-Hepatectomy
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data sets are available from the corresponding author on reasonable request.
Publications
Qian Y, Hou W, Yang L, Chen N, Zhang J. A randomized trial evaluating hemodynamics during minor hepatectomy under general anesthesia combined with thoracic epidural anesthesia: remimazolam versus propofol. BMC Anesthesiol. 2025 Aug 20;25(1):413. doi: 10.1186/s12871-025-03290-w.
PubMed 40836208
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remazolam on Hemodynamics During Hepatectomy Under General Anesthesia Combined With Thoracic Epidural Anesthesia
- ClinicalTrials.gov ID
- NCT06565715
- Acronym / sponsor ID
- Remazolam-Hepatectomy
- Conditions
- Hemodynamic Instability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Jun ZhangUniversity, hospital or other
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 22 Aug 2024 (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.
There is high incidence of hemodynamic instability in patients undergoing hepatectomy with low central venous pressure, especially in general anesthesia combined with epidural anesthesia. Remazolam, a new benzodiazepine, has no significant cardiovascular inhibitory effect. Investigators hypothesis that remazolam will provide better hemodynamic when compared with propofol in patients undergoing hepatectomy with general anesthesia combined with epidural anesthesia.
Detailed description
Investigators plan to adopt the following strategies in the clinical study of this project: (1) To compare remazolam and propofol during anesthetic induction and maintenance; (2) Remazolam group: remazolam is administered 0.3mg/kg intravenous for anesthesia induction. Propofol group: propofol is administered 2mg/kg intravenous for anesthesia induction; (3) Epidural analgesia is used during perioperative period, and remifentanil pump injection is used during the operation to assist the subjects to tolerate the tracheal catheter; (4) the haemodynamic instability score (Hemodynamic instability score) is used to comprehensively evaluate intraoperative hemodynamic status. (5) To evaluate the incidence of postoperative complications. Through the above strategies, investigators further determine the optimization effect of remazolam, a novel benzodiazepine drug, on intraoperative hemodynamics in patients undergoing low central venous pressure hepatectomy, and further lay an empirical foundation for the routine use of remazolam in clinical hepatectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remazolam group | Experimental | Drug: RemimazolamRemazolam group: remazolam is administered 0.3mg/kg intravenous for anesthesia induction. |
| Propofol group | Other | Drug: PropofolPropofol group: propofol is administered 2mg/kg intravenous for anesthesia induction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who sign informed consent and are willing to complete the study according to the plan;
- Over 18 years of age;
- ASA grade Ⅰ ~ Ⅲ;
- Elective surgery;
- General anesthesia combined with epidural anesthesia;
Key exclusion criteria (9 listed)
- Abnormal coagulation function;
- Abnormal platelet;
- A history of drug dependence;
- Neurological diseases;
- Severe sinus bradycardia (HR<50 beats/min);
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 |
|---|---|---|
| RemimazolamAlso: rebeninRemimazolam is used for sedation during anesthetic induction and maintenance. | Drug | Remazolam group |
| PropofolAlso: Propofol emulsionpropofol is used for sedation during anesthetic induction and maintenance. | Drug | Propofol group |
Primary outcome
Hemodynamic instability score
Time frame: intraoperative
The hemodynamic instability score is calculated as a weighted continuous measure ranging from 0 to 160 points, intended to reflect deviations of blood pressure and heart rate from predefined thresholds, and infusion rates of vasoactive agents and fluids.
4 secondary outcomes
Cardiac index （CI）
Time frame: intraoperative
Stroke volume variation (SVV)
Time frame: intraoperative
Systemic vascular resistance index (SVRI)
Time frame: intraoperative
Complications in 1 week after surgery
Time frame: 1 week after surgery
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 18 Mar 2025.
- Derived from this study: PubMed 40836208Qian Y, Hou W, Yang L, Chen N, Zhang J. A randomized trial evaluating hemodynamics during minor hepatectomy under general anesthesia combined with thoracic epidural anesthesia: remimazolam versus propofol. BMC Anesthesiol. 2025 Aug 20;25(1):413. doi: 10.1186/s12871-025-03290-w.
- Individual participant dataSharing planned: No. The data sets are available from the corresponding author on reasonable request.
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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.
Jun Zhang, Professor study chair
Fudan University
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 and Propofol in people with Hemodynamic Instability, run by Jun Zhang 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 9 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 18 Mar 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?
Hemodynamic instability score (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06565715, which also lists 1 linked publication.
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 18 Mar 2025.