Hypotension During SurgeryPhase 3NCT06714669
Comparison of General Anesthesia Hemodynamics Between R and P in Patients Undergoing Laparoscopic Hepatectomy
A Phase 3 study testing propofol and Remimazolam in people with Hypotension During Surgery, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study is a randomized controlled trial designed to investigate the effects of two anesthetics, remimazolam and propofol, on intraoperative hemodynamics in patients undergoing laparoscopic liver resection. The experimental group receives remimazolam, while the control group receives propofol. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypotension During Surgery
- What is being tested?
- propofol and Remimazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2024to 30 Oct 2024
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for LMH;
- Age 18-80 years, BMI 18-28 kg/m2;
- American Association of Anesthesiologists（ASA）I-III;
- Child-Pugh grade A or B;
- No serious heart, brain and other important organ lesions;
- Informed and consent, and signed informed consent.
Who cannot join
- ASA IV-V or Child-Pugh C;
- Left ventricular ejection fraction (EF) <30%;
- Implanted with temporary or permanent pacemakers;
- Organic heart disease;
- Uncontrolled hypertension, diabetes and other chronic diseases;
- Prolonged use of sedative and analgesic drugs (such as opioid analgesics, benzodiazepines, antianxiety, antidepressants, antipsychotics, etc.);
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- Alcohol addiction;
- Allergic to benzodiazepines or propofol, or to any ingredient in the studied drug;
- Known history of allergy to other anesthetics; difficulty in airway and intubation during induction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of General Anesthesia Hemodynamics Between Remimazolam and Propofol in Patients Undergoing Laparoscopic Hepatectomy: a Randomized, Controlled Trial.
This study is a randomized controlled trial designed to investigate the effects of two anesthetics, remimazolam and propofol, on intraoperative hemodynamics in patients undergoing laparoscopic liver resection. The experimental group receives remimazolam, while the control group receives propofol. The primary objective is to compare the hemodynamic responses of patients in both groups during the surgical procedure, aiming to provide insights into the potential differences in cardiovascular stability and anesthetic management associated with these two drugs
- Conditions
- Hypotension During Surgery
- Being tested
- propofol, Remimazolam
- Keywords
- hypotension, hemodynamics, general anesthesia, remimazolam, propofol
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Control Group (Propofol Anesthesia Arm):
Patients in this arm will receive Propofol as the primary anesthetic agent for general anesthesia. Propofol is a well-established anesthetic drug commonly used in clinical practice for its rapid onset and short duration of action. Similar to the experimental group, the dosing regimen and administration protocol for Propofol will be tailored to the individual patient's needs and the surgical procedure. Hemodynamic stability and other vital signs will also be closely monitored in this group to assess the safety and effectiveness of Propofol in comparison to Remimazolam.
RemimazolamDrug
Experimental Group (Remimazolam Anesthesia Arm):
Patients in this arm will receive Remimazolam as the primary anesthetic agent for inducing and maintaining general anesthesia. Remimazolam belongs to a new class of benzodiazepines and acts by enhancing the activity of GABAA receptors, leading to sedation and anesthesia. The specific dosing regimen and administration protocol for Remimazolam will be determined based on the patient's characteristics and the surgical procedure being performed. Close monitoring of the patient's vital signs, particularly hemodynamic parameters, will be conducted throughout the anesthesia period to ensure safety and efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm: Remimazolam Group | Experimental | Experimental Group (Remimazolam Anesthesia Arm): Patients in this arm will receive Remimazolam as the primary anesthetic agent for inducing and maintaining general anesthesia. The specific dosing regimen and administration protocol for Remimazolam will be determined based on the patient's characteristics and the surgical procedure being performed. Close monitoring of the patient's vital signs, particularly hemodynamic parameters, will be conducted throughout the anesthesia period to ensure safety and efficacy. Receives: Drug: Remimazolam |
| Control Arm: Propofol Group | Active comparator | Control Group (Propofol Anesthesia Arm):
Patients in this arm will receive Propofol as the primary anesthetic agent for general anesthesia. Propofol is a well-established anesthetic drug commonly used in clinical practice for its rapid onset and short duration of action. Similar to the experimental group, the dosing regimen and administration protocol for Propofol will be tailored to the individual patient's needs and the surgical procedure. Hemodynamic stability and other vital signs will also be closely monitored in this group to assess the safety and effectiveness of Propofol in comparison to Remimazolam. Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
The primary focus is to evaluate and compare the impact of Remimazolam and Propofol on hemodynamic parameters such as blood pressure (both systolic and diastolic). The objective is to assess whether Remimazolam causes less hemodynamic fluctuation compared to Propofol during the induction and maintenance of general anesthesia.
Measured: From enrollment to the end of treatment at 4 weeks
Heart rate
The primary focus is to evaluate and compare the impact of Remimazolam and Propofol on hemodynamic parameters such as heart rate. The objective is to assess whether Remimazolam causes less hemodynamic fluctuation compared to Propofol during the induction and maintenance of general anesthesia.
Measured: From enrollment to the end of treatment at 4 weeks
Mean arterial pressure
The primary focus is to evaluate and compare the impact of Remimazolam and Propofol on hemodynamic parameters such as mean arterial pressure. The objective is to assess whether Remimazolam causes less hemodynamic fluctuation compared to Propofol during the induction and maintenance of general anesthesia.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start20 Jun 2024
- Primary completion20 Oct 2024
- Study completion30 Oct 2024
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 Sun Yat-sen UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants in the experimental group used remimazolam as intravenous anesthetics while participants in the control group used propofol.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongguo Zhou, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714669
- Sponsor's protocol ID
- Zhongguo Zhou
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- 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 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of General Anesthesia Hemodynamics Between Remimazolam and Propofol in Patients Undergoing Laparoscopic Hepatectomy: a Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT06714669
- Acronym / sponsor ID
- Zhongguo Zhou
- Conditions
- Hypotension During Surgery
- Keywords
- hypotension, hemodynamics, general anesthesia, remimazolam, propofol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 20 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 3 Dec 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.
This study is a randomized controlled trial designed to investigate the effects of two anesthetics, remimazolam and propofol, on intraoperative hemodynamics in patients undergoing laparoscopic liver resection. The experimental group receives remimazolam, while the control group receives propofol. The primary objective is to compare the hemodynamic responses of patients in both groups during the surgical procedure, aiming to provide insights into the potential differences in cardiovascular stability and anesthetic management associated with these two drugs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- participants in the experimental group used remimazolam as intravenous anesthetics while participants in the control group used propofol.
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm: Remimazolam Group | Experimental | Drug: RemimazolamExperimental Group (Remimazolam Anesthesia Arm): Patients in this arm will receive Remimazolam as the primary anesthetic agent for inducing and maintaining general anesthesia. The specific dosing regimen and administration protocol for Remimazolam will be determined based on the patient's characteristics and the surgical procedure being performed. Close monitoring of the patient's vital signs, particularly hemodynamic parameters, will be conducted throughout the anesthesia period to ensure safety and efficacy. |
| Control Arm: Propofol Group | Active comparator | Drug: propofolControl Group (Propofol Anesthesia Arm): Patients in this arm will receive Propofol as the primary anesthetic agent for general anesthesia. Propofol is a well-established anesthetic drug commonly used in clinical practice for its rapid onset and short duration of action. Similar to the experimental group, the dosing regimen and administration protocol for Propofol will be tailored to the individual patient's needs and the surgical procedure. Hemodynamic stability and other vital signs will also be closely monitored in this group to assess the safety and effectiveness of Propofol in comparison to Remimazolam. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Scheduled for LMH;
- Age 18-80 years, BMI 18-28 kg/m2;
- American Association of Anesthesiologists（ASA）I-III;
- Child-Pugh grade A or B;
- No serious heart, brain and other important organ lesions;
Key exclusion criteria (9 listed)
- ASA IV-V or Child-Pugh C;
- Left ventricular ejection fraction (EF) <30%;
- Implanted with temporary or permanent pacemakers;
- Organic heart disease;
- Uncontrolled hypertension, diabetes and other chronic diseases;
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 |
|---|---|---|
| propofolControl Group (Propofol Anesthesia Arm): Patients in this arm will receive Propofol as the primary anesthetic agent for general anesthesia. Propofol is a well-established anesthetic drug commonly used in clinical practice for its rapid onset and short duration of action. Similar to the experimental group, the dosing regimen and administration protocol for Propofol will be tailored to the individual patient's needs and the surgical procedure. Hemodynamic stability and other vital signs will also be closely monitored in this group to assess the safety and effectiveness of Propofol in comparison to Remimazolam. | Drug | Control Arm: Propofol Group |
| RemimazolamExperimental Group (Remimazolam Anesthesia Arm): Patients in this arm will receive Remimazolam as the primary anesthetic agent for inducing and maintaining general anesthesia. Remimazolam belongs to a new class of benzodiazepines and acts by enhancing the activity of GABAA receptors, leading to sedation and anesthesia. The specific dosing regimen and administration protocol for Remimazolam will be determined based on the patient's characteristics and the surgical procedure being performed. Close monitoring of the patient's vital signs, particularly hemodynamic parameters, will be conducted throughout the anesthesia period to ensure safety and efficacy. | Drug | Experimental Arm: Remimazolam Group |
Primary outcome
Blood pressure
Time frame: From enrollment to the end of treatment at 4 weeks
The primary focus is to evaluate and compare the impact of Remimazolam and Propofol on hemodynamic parameters such as blood pressure (both systolic and diastolic). The objective is to assess whether Remimazolam causes less hemodynamic fluctuation compared to Propofol during the induction and maintenance of general anesthesia.
Heart rate
Time frame: From enrollment to the end of treatment at 4 weeks
The primary focus is to evaluate and compare the impact of Remimazolam and Propofol on hemodynamic parameters such as heart rate. The objective is to assess whether Remimazolam causes less hemodynamic fluctuation compared to Propofol during the induction and maintenance of general anesthesia.
Mean arterial pressure
Time frame: From enrollment to the end of treatment at 4 weeks
The primary focus is to evaluate and compare the impact of Remimazolam and Propofol on hemodynamic parameters such as mean arterial pressure. The objective is to assess whether Remimazolam causes less hemodynamic fluctuation compared to Propofol during the induction and maintenance of general 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 3 Dec 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing propofol and Remimazolam in people with Hypotension During Surgery, run by Sun Yat-sen University 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 3 Dec 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Blood pressure (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 3 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 3 Dec 2024.