Intraoperative HypotensionPhase 4REPOSE-1NCT05436522
REmimazolam vs PrOpofol on Intraoperative hypotenSion in Major Noncardiac surgEry
A Phase 4 study testing Remimazolam and Propofol in people with Intraoperative Hypotension, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Intraoperative hypotension is common during major noncardiac surgery and is associated with adverse postoperative outcomes. Propofol, the most commonly used intravenous anesthetic agent worldwide, is associated with hypotension on induction and maintenance of general anesthesia. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Intraoperative Hypotension
- 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
- 340 participants
- Where
- 1 siteChina
- Study dates
- 22 Aug 2022to 21 Jun 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥45 years;
- Undergoing elective major surgery under general anesthesia (expected surgery time >2 h, expected length of postoperative stay >2 d);
- Need for intraoperative invasive blood pressure monitoring via arterial line;
- Fulfilling ≥1 of the following criteria (a-k):
- history of coronary artery disease;
- history of stroke;
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- history of congestive heart failure;
- preoperative NT-proBNP >200 pg/mL;
- preoperative high sensitivity troponin T > 14 ng/L;
- age ≥70 years;
- diabetes requiring medical treatment;
- ASA status 3 or 4;
- history of chronic kidney disease (preoperative sCr >133μmol/L or 1.5 mg/dL);
- preoperative serum albumin <30 g/L;
- preoperative hemoglobin <100 g/L.
Who cannot join
- Undergoing organ transplantation, cardiac, neurological, or adrenal gland surgery;
- Planned intraoperative MAP higher or lower than 65 mmHg;
- Severe untreated or uncontrolled hypertension (preoperative SBP >180 mmHg and/or DBP >110 mmHg);
- End-stage renal disease requiring renal-replacement therapy;
- ASA score ≥5;
- Preoperative requirement of vasopressor infusion;
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- Unable to receive bispectral index monitoring;
- Known allergy to benzodiazepines, propofol, opioids or cisatracurium;
- Current participation in another interventional study;
- Previous participation in this study;
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Total Intravenous Anesthesia With Remimazolam vs Propofol on Intraoperative Hypotension in Major Noncardiac Surgery: a Randomized Controlled Trial
Intraoperative hypotension is common during major noncardiac surgery and is associated with adverse postoperative outcomes. Propofol, the most commonly used intravenous anesthetic agent worldwide, is associated with hypotension on induction and maintenance of general anesthesia. Remimazolam is a newly developed short-acting benzodiazepine drug and has been approved for use in procedural sedation and general anesthesia. It was associated with a lower incidence of hypotension during procedural sedation in previous studies. The aim of this study is to tested the primary hypothesis that total intravenous anesthesia with remimazolam reduces the duration and severity of hypotension during major noncardiac surgery compared with total intravenous anesthesia with propofol.
- Conditions
- Intraoperative Hypotension
- Being tested
- Remimazolam, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Remimazolam is administered intravenously for induction and maintenance of general anesthesia. The dose is titrated to maintain Bispectral Index value between 40 and 60.
PropofolDrug
Propofol is administered intravenously for induction and maintenance of general anesthesia. The dose is titrated to maintain Bispectral Index value between 40 and 60.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam TIVA | Experimental | Induction: Remimazolam, sufentanil, cisatracurium. Maintenance: Remimazolam, remifentanil, cisatracurium. Receives: Drug: Remimazolam |
| Propofol TIVA | Active comparator | Induction: Propofol, sufentanil, cisatracurium. Maintenance: Propofol, remifentanil, cisatracurium. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 65 mmHg.
TWA-MAP under 65 mmHg for each patient is derived by dividing area under the curve (AUC)-MAP under 65 mmHg by the time interval between the first and the last MAP measurements.
Measured: MAP measurements are recorded every minute from of anesthesia induction to end of wound closure.
Secondary outcomes (11)
AUC-MAP under 65 mmHg.
AUC-MAP under 65 mmHg for each patient is derived by depth of hypotension in millimeters of mercury below a MAP of 65 mmHg × time in minutes spent below a MAP of 65 mmHg.
Measured: From of anesthesia induction to end of wound closure.
Duration of MAP under 65 mmHg.
Duration of MAP under 65 mmHg is the total amount of time in minutes that the MAP is under 65 mmHg.
Measured: From of anesthesia induction to end of wound closure.
Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 70 mmHg.
TWA-MAP under 70 mmHg for each patient is derived by dividing area under the curve (AUC)-MAP under 70 mmHg by the time interval between the first and the last MAP measurements.
Measured: From of anesthesia induction to end of wound closure.
AUC-MAP under 70 mmHg.
AUC-MAP under 70 mmHg for each patient is derived by depth of hypotension in millimeters of mercury below a MAP of 70 mmHg × time in minutes spent below a MAP of 70 mmHg.
Measured: From of anesthesia induction to end of wound closure.
Duration of MAP under 70 mmHg.
Duration of MAP under 70 mmHg is the total amount of time in minutes that the MAP is under 70 mmHg.
Measured: From of anesthesia induction to end of wound closure.
Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 60 mmHg.
TWA-MAP under 60 mmHg for each patient is derived by dividing area under the curve (AUC)-MAP under 60 mmHg by the time interval between the first and the last MAP measurements.
Measured: From of anesthesia induction to end of wound closure.
AUC-MAP under 60 mmHg.
AUC-MAP under 60 mmHg for each patient is derived by depth of hypotension in millimeters of mercury below a MAP of 60 mmHg × time in minutes spent below a MAP of 60 mmHg.
Measured: From of anesthesia induction to end of wound closure.
Duration of MAP under 60 mmHg.
Duration of MAP under 60 mmHg is the total amount of time in minutes that the MAP is under 60 mmHg.
Measured: From of anesthesia induction to end of wound closure.
Postoperative complications.
A composite of in-hospital all-cause mortality and cardiovascular, neurological, renal, respiratory, and infectious complications.
Measured: From end of surgery to 30 days after surgery.
Days alive and at home.
Number of days alive and at home within 30 days after surgery.
Measured: From end of surgery to 30 days after surgery.
Postoperative quality of recovery.
Patient-reported quality of recovery after surgery and anesthesia with the QoR-15, ranging from 0 (poor recovery) to 150 (excellent recovery)
Measured: At postoperative day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start22 Aug 2022
- Primary completion21 May 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative HypotensionStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436522
- Sponsor's protocol ID
- NFEC-2021-260
- Acronym
- REPOSE-1
- Status last verified
- Feb 2025
- First submitted
- 9 May 2022
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The deidentified IPD will be shared upon reasonable request after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Total Intravenous Anesthesia With Remimazolam vs Propofol on Intraoperative Hypotension in Major Noncardiac Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05436522
- Acronym / sponsor ID
- REPOSE-1 / NFEC-2021-260
- Conditions
- Intraoperative Hypotension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 29 Jun 2022 (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.
Intraoperative hypotension is common during major noncardiac surgery and is associated with adverse postoperative outcomes. Propofol, the most commonly used intravenous anesthetic agent worldwide, is associated with hypotension on induction and maintenance of general anesthesia. Remimazolam is a newly developed short-acting benzodiazepine drug and has been approved for use in procedural sedation and general anesthesia. It was associated with a lower incidence of hypotension during procedural sedation in previous studies. The aim of this study is to tested the primary hypothesis that total intravenous anesthesia with remimazolam reduces the duration and severity of hypotension during major noncardiac surgery compared with total intravenous anesthesia with propofol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam TIVA | Experimental | Drug: RemimazolamInduction: Remimazolam, sufentanil, cisatracurium. Maintenance: Remimazolam, remifentanil, cisatracurium. |
| Propofol TIVA | Active comparator | Drug: PropofolInduction: Propofol, sufentanil, cisatracurium. Maintenance: Propofol, remifentanil, cisatracurium. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥45 years;
- Undergoing elective major surgery under general anesthesia (expected surgery time >2 h, expected length of postoperative stay >2 d);
- Need for intraoperative invasive blood pressure monitoring via arterial line;
- Fulfilling ≥1 of the following criteria (a-k):
Key exclusion criteria (11 listed)
- Undergoing organ transplantation, cardiac, neurological, or adrenal gland surgery;
- Planned intraoperative MAP higher or lower than 65 mmHg;
- Severe untreated or uncontrolled hypertension (preoperative SBP >180 mmHg and/or DBP >110 mmHg);
- End-stage renal disease requiring renal-replacement therapy;
- ASA score ≥5;
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 is administered intravenously for induction and maintenance of general anesthesia. The dose is titrated to maintain Bispectral Index value between 40 and 60. | Drug | Remimazolam TIVA |
| PropofolPropofol is administered intravenously for induction and maintenance of general anesthesia. The dose is titrated to maintain Bispectral Index value between 40 and 60. | Drug | Propofol TIVA |
Primary outcome
Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 65 mmHg.
Time frame: MAP measurements are recorded every minute from of anesthesia induction to end of wound closure.
TWA-MAP under 65 mmHg for each patient is derived by dividing area under the curve (AUC)-MAP under 65 mmHg by the time interval between the first and the last MAP measurements.
11 secondary outcomes
AUC-MAP under 65 mmHg.
Time frame: From of anesthesia induction to end of wound closure.
Duration of MAP under 65 mmHg.
Time frame: From of anesthesia induction to end of wound closure.
Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 70 mmHg.
Time frame: From of anesthesia induction to end of wound closure.
AUC-MAP under 70 mmHg.
Time frame: From of anesthesia induction to end of wound closure.
Duration of MAP under 70 mmHg.
Time frame: From of anesthesia induction to end of wound closure.
Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 60 mmHg.
Time frame: From of anesthesia induction to end of wound closure.
AUC-MAP under 60 mmHg.
Time frame: From of anesthesia induction to end of wound closure.
Duration of MAP under 60 mmHg.
Time frame: From of anesthesia induction to end of wound closure.
Postoperative complications.
Time frame: From end of surgery to 30 days after surgery.
Days alive and at home.
Time frame: From end of surgery to 30 days after surgery.
Postoperative quality of recovery.
Time frame: At postoperative day 1.
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 6 Feb 2025.
- Individual participant dataSharing planned: Yes. The deidentified IPD will be shared upon reasonable request after study completion.
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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 4 study testing Remimazolam and Propofol in people with Intraoperative Hypotension, run by Nanfang Hospital, Southern Medical 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 15 inclusion and 11 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 6 Feb 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?
Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 65 mmHg. (time frame: MAP measurements are recorded every minute from of anesthesia induction to end of wound closure.). 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 6 Feb 2025.