Hemodynamic Effects of Remimazolam vs Propofol During Robot-assisted Gynecologic Surgery
NCT ID: NCT07251101
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
58 participants
INTERVENTIONAL
2026-01-02
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Group_R
TIVA with remimazolam plus remifentanil
Remimazolam
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.
Group_P
TIVA with propofol plus remifentanil
Propofol
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.
Interventions
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Remimazolam
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.
Propofol
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists (ASA) physical status I-II
* Scheduled to undergo robotic hysterectomy under general anesthesia
Exclusion Criteria
* 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
65 Years
FEMALE
No
Sponsors
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Ilsan Cha hospital
OTHER
Responsible Party
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Joohyun Lee
Assistant Professor, Department of Anesthesiology and Pain Medicine, CHA University
Locations
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CHA Ilsan Medical Center
Goyang-si, Gyeonggi-do, South Korea
CHA Ilsan Medical Center
Goyang-si, , South Korea
Countries
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Central Contacts
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Joohyun Lee Assistant Professor, Dept. of Anesthesiology and Pain Medicine, MD
Role: CONTACT
Other Identifiers
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ICHA 2025-07-005
Identifier Type: -
Identifier Source: org_study_id
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