Anesthesia, IntravenousBy_HDNCT07251101
Hemodynamic Effects of Remimazolam vs Propofol During Robot-assisted Gynecologic Surgery
A study testing Remimazolam and Propofol in people with Anesthesia, Intravenous and Hemodynamic Stability, run by Ilsan Cha hospital at 2 sites in South Korea.
Trial summary
This single-center study at CHA Ilsan Medical Center compares intraoperative hemodynamics between remimazolam- and propofol-based total intravenous anesthesia (TIVA) in patients undergoing robot-assisted gynecologic surgery requiring pneumoperitoneum and steep Trendelenburg positioning. Read more about this study
- Who is it for?
- Ages Up to 65 years, women only
- Conditions the study is for
- Anesthesia, Intravenous, Hemodynamic Stability, Gynecologic Surgery
- What is being tested?
- Remimazolam and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 2 May 2026to 30 Dec 2027
- Phase
- Interventional
- 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 Up to 65 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female patients <65 years of age
- American Society of Anesthesiologists (ASA) physical status I-II
- Scheduled to undergo robotic hysterectomy under general anesthesia
Who cannot join
- Body mass index (BMI) > 35 kg/m²
- Baseline hypotension (systolic blood pressure <100 mmHg) or bradycardia (heart rate <60 bpm)
- History of ischemic heart disease or cardiac conduction block
- Significant cardiopulmonary disease, including hypoxemia (SpO₂ <90%), uncontrolled asthma, or chronic obstructive pulmonary disease (COPD)
- Use of inhalational anesthetics during anesthesia
- Conversion from robotic/laparoscopic surgery to open laparotomy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Joohyun Lee Assistant Professor, Dept. of Anesthesiology and Pain Medicine, MD contact
South Korea2 sites
CHA Ilsan Medical Center
Goyang-si, Gyeonggi-do, 10414
CHA Ilsan Medical Center
Goyang-si
About this study
Official title: A Randomized, Parallel, Open-label With Blinded Assessment Study Comparing Hemodynamic Profiles Between Remimazolam- and Propofol-based Total Intravenous Anesthesia in Patients Undergoing Robot-assisted Gynecologic Surgery
This single-center study at CHA Ilsan Medical Center compares intraoperative hemodynamics between remimazolam- and propofol-based total intravenous anesthesia (TIVA) in patients undergoing robot-assisted gynecologic surgery requiring pneumoperitoneum and steep Trendelenburg positioning.
Read the detailed description
This study aims to compare intraoperative hemodynamic characteristics between remimazolam- and propofol-based total intravenous anesthesia (TIVA) in patients undergoing robot-assisted gynecologic surgery. Continuous invasive blood pressure will be analyzed to evaluate time-weighted average (TWA) and area-under-the-curve (AUC) differences between groups. The study is designed as a randomized, parallel, open-label with blinded assessment trial.
- Being tested
- Remimazolam, Propofol
- Keywords
- remimazolam, propofol, hemodynamics, laparoscopic surgery, general anesthesia, Trendelenburg position, pneumoperitoneum, gynecologic surgery, total intravenous anesthesia (TIVA)
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Also called Byfavo
Induction with remimazolam 6 mg·kg-¹·h-¹ with remifentanil Ce 4 ng·mL-¹ (Minto model); maintenance remimazolam 1-2 mg·kg-¹·h-¹, titrated (±0.2) to maintain PSI 25-50 and hemodynamic targets. Standard care otherwise per protocol.
PropofolDrug
Also called Fresofol MCT 2%
Induction with propofol Ce 4 ng·mL-¹ with remifentanil Ce 4 ng·mL-¹; maintenance propofol Ce 2.5-3.5 ng·mL-¹, titrated (±0.2) to maintain PSI 25-50 and hemodynamic targets. Standard care otherwise per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Group_R | Experimental | TIVA with remimazolam plus remifentanil Receives: Drug: Remimazolam |
| Group_P | Active comparator | TIVA with propofol plus remifentanil Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAP (Time-Weighted Average)
Continuous invasive arterial pressure is recorded throughout anesthesia. For each participant, TWA-MAP is computed as the integral of MAP over elapsed time divided by total observation time (trapezoidal rule). Data are aggregated at ~1-min resolution when possible. Implausible artifacts (e.g., MAP <30 or >180 mmHg) are excluded. The primary comparison is the between-group difference in TWA-MAP (remimazolam vs propofol) for validating hypothesis (remimazolam-based TIVA maintains ≥20% higher intraoperative MAP than propofol-based TIVA). Primary analysis will use ANCOVA adjusting for baseline MAP and prespecified covariates, with a one-sided significance level of 0.05.
Measured: from induction start (first anesthetic administration) to operating room exit (transfer from OR), approximately up to 5 hours per participant.
Secondary outcomes (2)
Area Under the Curve (AUC) for Hypertensive Burden
Continuous invasive arterial pressure is recorded throughout anesthesia. For each participant, the AUC above the hypertensive threshold (SBP ≥140 mmHg or MAP ≥100 mmHg) is calculated as mmHg·minutes using the trapezoidal rule. This measure represents the cumulative burden of intraoperative hypertension. Group comparisons will assess whether remimazolam-based TIVA differs from propofol-based TIVA in hypertensive burden.
Measured: from anesthesia induction to operating room exit, assessed continuously during surgery (approximately 2 to 5 hours per participant).
Area Under the Curve (AUC) for Hypotensive Burden
Continuous invasive arterial pressure is recorded throughout anesthesia. For each participant, the AUC below the hypotensive threshold (SBP <90 mmHg or MAP <65 mmHg) is calculated as mmHg·minutes using the trapezoidal rule. This measure represents the cumulative burden of intraoperative hypotension. Group comparisons will assess whether remimazolam-based TIVA differs from propofol-based TIVA in hypotensive burden.
Measured: from anesthesia induction to operating room exit, assessed continuously during surgery (approximately 2 to 5 hours per participant).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start2 May 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
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 Anesthesia, IntravenousStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ilsan Cha hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joohyun Lee, Ilsan Cha hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251101
- Sponsor's protocol ID
- ICHA 2025-07-005
- Acronym
- By_HD
- Status last verified
- Mar 2026
- First submitted
- 25 Sep 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Summary results will be published in peer-reviewed journals and presented at scientific meetings.
Publications
Lee JM, Lee J, Kang SH, Jung K, Yeo H, Lee JY, Joo Y. Comparison of intraoperative hemodynamic parameters between propofol- and remimazolam-based total intravenous anesthesia in patients undergoing robotic gynecologic surgery: a randomized controlled trial protocol. Front Pharmacol. 2026 Jul 20;17:1775804. doi: 10.3389/fphar.2026.1775804. eCollection 2026.
PubMed 42544348
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel, Open-label With Blinded Assessment Study Comparing Hemodynamic Profiles Between Remimazolam- and Propofol-based Total Intravenous Anesthesia in Patients Undergoing Robot-assisted Gynecologic Surgery
- ClinicalTrials.gov ID
- NCT07251101
- Acronym / sponsor ID
- By_HD / ICHA 2025-07-005
- Keywords
- remimazolam, propofol, hemodynamics, laparoscopic surgery, general anesthesia, Trendelenburg position, pneumoperitoneum, gynecologic surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Ilsan Cha hospitalUniversity, hospital or other
- Study start
- 2 May 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 26 Nov 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.
This single-center study at CHA Ilsan Medical Center compares intraoperative hemodynamics between remimazolam- and propofol-based total intravenous anesthesia (TIVA) in patients undergoing robot-assisted gynecologic surgery requiring pneumoperitoneum and steep Trendelenburg positioning.
Detailed description
This study aims to compare intraoperative hemodynamic characteristics between remimazolam- and propofol-based total intravenous anesthesia (TIVA) in patients undergoing robot-assisted gynecologic surgery. Continuous invasive blood pressure will be analyzed to evaluate time-weighted average (TWA) and area-under-the-curve (AUC) differences between groups. The study is designed as a randomized, parallel, open-label with blinded assessment trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group_R | Experimental | Drug: RemimazolamTIVA with remimazolam plus remifentanil |
| Group_P | Active comparator | Drug: PropofolTIVA with propofol plus remifentanil |
Who may qualify
- Ages
- Up to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients <65 years of age
- American Society of Anesthesiologists (ASA) physical status I-II
- Scheduled to undergo robotic hysterectomy under general anesthesia
Key exclusion criteria (6 listed)
- Body mass index (BMI) > 35 kg/m²
- Baseline hypotension (systolic blood pressure <100 mmHg) or bradycardia (heart rate <60 bpm)
- History of ischemic heart disease or cardiac conduction block
- Significant cardiopulmonary disease, including hypoxemia (SpO₂ <90%), uncontrolled asthma, or chronic obstructive pulmonary disease (COPD)
- Use of inhalational anesthetics during anesthesia
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: ByfavoInduction with remimazolam 6 mg·kg-¹·h-¹ with remifentanil Ce 4 ng·mL-¹ (Minto model); maintenance remimazolam 1-2 mg·kg-¹·h-¹, titrated (±0.2) to maintain PSI 25-50 and hemodynamic targets. Standard care otherwise per protocol. | Drug | Group_R |
| PropofolAlso: Fresofol MCT 2%Induction with propofol Ce 4 ng·mL-¹ with remifentanil Ce 4 ng·mL-¹; maintenance propofol Ce 2.5-3.5 ng·mL-¹, titrated (±0.2) to maintain PSI 25-50 and hemodynamic targets. Standard care otherwise per protocol. | Drug | Group_P |
Primary outcome
MAP (Time-Weighted Average)
Time frame: from induction start (first anesthetic administration) to operating room exit (transfer from OR), approximately up to 5 hours per participant.
Continuous invasive arterial pressure is recorded throughout anesthesia. For each participant, TWA-MAP is computed as the integral of MAP over elapsed time divided by total observation time (trapezoidal rule). Data are aggregated at ~1-min resolution when possible. Implausible artifacts (e.g., MAP <30 or >180 mmHg) are excluded. The primary comparison is the between-group difference in TWA-MAP (remimazolam vs propofol) for validating hypothesis (remimazolam-based TIVA maintains ≥20% higher intraoperative MAP than propofol-based TIVA). Primary analysis will use ANCOVA adjusting for baseline MAP and prespecified covariates, with a one-sided significance level of 0.05.
2 secondary outcomes
Area Under the Curve (AUC) for Hypertensive Burden
Time frame: from anesthesia induction to operating room exit, assessed continuously during surgery (approximately 2 to 5 hours per participant).
Area Under the Curve (AUC) for Hypotensive Burden
Time frame: from anesthesia induction to operating room exit, assessed continuously during surgery (approximately 2 to 5 hours per participant).
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 27 Mar 2026.
- Derived from this study: PubMed 42544348Lee JM, Lee J, Kang SH, Jung K, Yeo H, Lee JY, Joo Y. Comparison of intraoperative hemodynamic parameters between propofol- and remimazolam-based total intravenous anesthesia in patients undergoing robotic gynecologic surgery: a randomized controlled trial protocol. Front Pharmacol. 2026 Jul 20;17:1775804. doi: 10.3389/fphar.2026.1775804. eCollection 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Summary results will be published in peer-reviewed journals and presented at scientific meetings.
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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.
Joohyun Lee Assistant Professor, Dept. of Anesthesiology and Pain Medicine, MD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam and Propofol in people with Anesthesia, Intravenous and Hemodynamic Stability, run by Ilsan Cha hospital at 2 sites in South Korea.
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 3 inclusion and 6 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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.
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 Joohyun Lee Assistant Professor, Dept. of Anesthesiology and Pain Medicine, MD (+82-31-782-8415, hightothesky1004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MAP (Time-Weighted Average) (time frame: from induction start (first anesthetic administration) to operating room exit (transfer from OR), approximately up to 5 hours per participant.). 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 NCT07251101, 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 27 Mar 2026.