Gynecological SurgeryNCT06385002
Effect of Combined Administration of Sevoflurane and Remimazolam on Emergence
A study testing Remimazolam in people with Gynecological Surgery, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial summary
Enhanced recovery after surgery (ERAS) protocols are being explored to improve patient outcomes. The method of inducing anesthesia and maintenance using inhalation anesthetics is common but may delay recovery. Remimazolam, a benzodiazepine-class drug, is noted for its rapid metabolism and fewer hemodynamic changes. Read more about this study
- Who is it for?
- Ages 19 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecological Surgery
- What is being tested?
- Remimazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Jul 2023to 30 Jun 2025
- Phase
- Interventional
- 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 19 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients aged 19 to 70 undergoing gynecologic and laparoscopic surgery under general anesthesia
- Patients classified as American Society of Anesthesiologists (ASA) physical status classification I or II
- According to the American Society of Anesthesiologists (ASA) physical status classification:
- Class I - Healthy patients without systemic disease Class II - Patients with mild systemic disease without functional limitation Class III - Patients with severe systemic disease that limits activity but is not incapacitating Class IV - Patients with incapacitating systemic disease that is a constant threat to life Class V - Moribund patients who are not expected to survive without the operation Class VI - Brain-dead patients for organ donation
Who cannot join
- Patients classified as ASA physical status classification III or above
- Pregnant women
- Patients with hypersensitivity to sevoflurane or other halogenated anesthetics, malignant hyperthermia, or a history of it in the patient or family
- Patients with preoperative impairment of consciousness or coma
- Patients undergoing emergency surgery or those who are hemodynamically unstable preoperatively
- Patients with a history of neuromuscular disorders or medication affecting neuromuscular function
Show all 14Show fewer
- Patients who have taken sedatives (anxiolytics, hypnotics, antipsychotics, antidepressants, or sleeping pills) within 24 hours
- Patients receiving long-term benzodiazepine therapy
- Patients with alcohol or substance dependence
- Patients with allergy history to benzodiazepines or flumazenil
- Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Patients with severe hypersensitivity reactions to dextran 40
- Patients with chronic renal failure requiring hemodialysis
- Patients with a history of acute angle-closure glaucoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Combined Administration of Sevoflurane and Remimazolam on Emergence in Patients Undergoing Gynecological Laparoscopic Surgery Under General Anesthesia: a Prospective Randomized Controlled Study
Enhanced recovery after surgery (ERAS) protocols are being explored to improve patient outcomes. The method of inducing anesthesia and maintenance using inhalation anesthetics is common but may delay recovery. Remimazolam, a benzodiazepine-class drug, is noted for its rapid metabolism and fewer hemodynamic changes. Research suggests combining sevoflurane and propofol for anesthesia in adults enhances recovery, while studies in pediatric patients indicate a reduction in emergence agitation with remimazolam. However, the impact of combining sevoflurane and remimazolam on postoperative recovery in adult patients undergoing gynecologic and laparoscopic surgery is not yet studied. The study aims to compare the time to emergence from anesthesia and tracheal extubation between concurrent sevoflurane and remimazolam administration versus sevoflurane alone.
Read the detailed description
- Laparoscopic oophorectomy or hysterectomy is a commonly performed gynecological surgery, and rapid recovery, pain management, prevention of postoperative nausea and vomiting are important factors determining early discharge and patient satisfaction. With the recent emergence of enhanced recovery after surgery (ERAS), various clinical studies are being conducted to improve the quality of patient recovery through decisions regarding anesthesia methods and agents, fluid administration, prevention of nausea and vomiting, and pain management during surgery.
- The method of inducing anesthesia with intravenous injection of anesthetic agents such as propofol followed by maintenance of anesthesia using inhalation anesthetics is generally performed as a method of general anesthesia. Inhalation anesthetics commonly used for maintenance of anesthesia can be easily administered and removed via ventilation, and they have the advantage of maintaining anesthesia depth relatively easily by monitoring parameters such as bispectral Index (BIS) and end-tidal gas concentration. However, it has the disadvantage of delaying recovery and increasing hospital stay due to postoperative nausea and vomiting, and it decreases average arterial pressure proportionally to the dose due to systemic vasodilation.
- Remimazolam (Byfavo Inj., Hana Pharm Col, Ltd., Seoul, Korea) is a benzodiazepine-class drug used for induction and maintenance of general anesthesia and for sedation during procedures. When remimazolam is used as a general anesthetic, it is rapidly metabolized by enzymes in the liver compared to propofol, resulting in a short context-sensitive half-life of 7.5 minutes and allowing for reversal with flumazenil. Additionally, it is known to induce fewer hemodynamic changes.
- There is research indicating that combining sevoflurane and propofol (target plasma concentration 1.2 mcg/mL) for general anesthesia in adult patients reduces arousal excitement and provides rapid recovery. However, in general anesthesia using desflurane or remimazolam, the time to tracheal extubation was longer in the remimazolam group. Furthermore, there is research suggesting that combining remimazolam with inhalation anesthesia during general anesthesia in pediatric patients can reduce the occurrence of emergence agitation after surgery, but the time to emergence is longer. However, there is currently no research on the effects of combining sevoflurane and remimazolam for general anesthesia in adult patients on postoperative arousal and recovery.
The objective of this study is to investigate whether there is a difference in the time to emergence from anesthesia and time to tracheal extubation in patients undergoing gynecologic and laparoscopic surgery under general anesthesia, comparing the concurrent administration of sevoflurane and remimazolam with the maintenance of anesthesia using sevoflurane alone.
- Conditions
- Gynecological Surgery
- Being tested
- Remimazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Also called Byfavo
After tracheal intubation, the experimental group will maintain oxygen-air (O2-Air) at 2 liters/minute, and remimazolam will be infused at 1.0mg/kg/h, while adjusting the concentration of sevoflurane to maintain the depth of anesthesia with a bispectral index (BIS) of 40-60.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane group, S group | No intervention | The control group will maintain oxygen-air (O2-Air) at 2 L/min and adjust the concentration of sevoflurane to maintain the depth of anesthesia with a bispectral index (BIS) of 40-60. |
| Remimazolam/Sevoflurane group, RS group | Active comparator | After tracheal intubation, the experimental group will maintain oxygen-air (O2-Air) at 2 liters/minute, and remimazolam will be infused at 1.0mg/kg/h, while adjusting the concentration of sevoflurane to maintain the depth of anesthesia with a bispectral index (BIS) of 40-60. Receives: Drug: Remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to emergence
A comparison will be made between the time to emergence from anesthesia in patients receiving concurrent administration of sevoflurane and remimazolam versus those maintained on sevoflurane alone after surgery.
Measured: Immediate after the end of general anesthesia
time to tracheal extubation
A comparison will be made between the time to tracheal extubation in patients receiving concurrent administration of sevoflurane and remimazolam versus those maintained on sevoflurane alone after surgery.
Measured: Immediate after the end of general anesthesia
Secondary outcomes (5)
usage of vasopressors
usage of vasopressors during general anesthesia
Measured: During general anesthesia
severity of cough
severity of cough during tracheal extubation
Measured: immediate after the end of general anesthesia
time to discharge from the recovery room
time to discharge from the recovery room
Measured: immediate after entering the PACU until until achieving post-anesthesia recovery score of 9 or more
postoperative pain scores
Visual analog scale (VAS) is going to be measured after entering the PACU. The VAS is a validated, subjective measure for acute and chronic pain. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Measured: Immediate after entering the PACU, 15 minutes after entering the PACU
scores for postoperative nausea and vomiting
Postoperative nausea was evaluated by means of a classical VAS (0-10 cm) device and a 4-point VDS (verbal descriptive scale,0=no nausea, 1=mild, 2=moderate, 3=severe).
Measured: Immediate after entering the PACU, 15 minutes after entering the PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start31 Jul 2023
- Primary completion31 Aug 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological SurgeryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Hee Young, Pusan National University Yangsan Hospital
- Investigators
- Hee Young Kim, MD, PhD, Principal investigator, Department of Anesthesia and Pain Medicine, School of Medicine, Pusan National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385002
- Sponsor's protocol ID
- 2024-0158
- Status last verified
- Jul 2025
- First submitted
- 19 Apr 2024
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Administration of Sevoflurane and Remimazolam on Emergence in Patients Undergoing Gynecological Laparoscopic Surgery Under General Anesthesia: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06385002
- Acronym / sponsor ID
- 2024-0158
- Conditions
- Gynecological Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 25 Apr 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.
Enhanced recovery after surgery (ERAS) protocols are being explored to improve patient outcomes. The method of inducing anesthesia and maintenance using inhalation anesthetics is common but may delay recovery. Remimazolam, a benzodiazepine-class drug, is noted for its rapid metabolism and fewer hemodynamic changes. Research suggests combining sevoflurane and propofol for anesthesia in adults enhances recovery, while studies in pediatric patients indicate a reduction in emergence agitation with remimazolam. However, the impact of combining sevoflurane and remimazolam on postoperative recovery in adult patients undergoing gynecologic and laparoscopic surgery is not yet studied. The study aims to compare the time to emergence from anesthesia and tracheal extubation between concurrent sevoflurane and remimazolam administration versus sevoflurane alone.
Detailed description
- Laparoscopic oophorectomy or hysterectomy is a commonly performed gynecological surgery, and rapid recovery, pain management, prevention of postoperative nausea and vomiting are important factors determining early discharge and patient satisfaction. With the recent emergence of enhanced recovery after surgery (ERAS), various clinical studies are being conducted to improve the quality of patient recovery through decisions regarding anesthesia methods and agents, fluid administration, prevention of nausea and vomiting, and pain management during surgery.
- The method of inducing anesthesia with intravenous injection of anesthetic agents such as propofol followed by maintenance of anesthesia using inhalation anesthetics is generally performed as a method of general anesthesia. Inhalation anesthetics commonly used for maintenance of anesthesia can be easily administered and removed via ventilation, and they have the advantage of maintaining anesthesia depth relatively easily by monitoring parameters such as bispectral Index (BIS) and end-tidal gas concentration. However, it has the disadvantage of delaying recovery and increasing hospital stay due to postoperative nausea and vomiting, and it decreases average arterial pressure proportionally to the dose due to systemic vasodilation.
- Remimazolam (Byfavo Inj., Hana Pharm Col, Ltd., Seoul, Korea) is a benzodiazepine-class drug used for induction and maintenance of general anesthesia and for sedation during procedures. When remimazolam is used as a general anesthetic, it is rapidly metabolized by enzymes in the liver compared to propofol, resulting in a short context-sensitive half-life of 7.5 minutes and allowing for reversal with flumazenil. Additionally, it is known to induce fewer hemodynamic changes.
- There is research indicating that combining sevoflurane and propofol (target plasma concentration 1.2 mcg/mL) for general anesthesia in adult patients reduces arousal excitement and provides rapid recovery. However, in general anesthesia using desflurane or remimazolam, the time to tracheal extubation was longer in the remimazolam group. Furthermore, there is research suggesting that combining remimazolam with inhalation anesthesia during general anesthesia in pediatric patients can reduce the occurrence of emergence agitation after surgery, but the time to emergence is longer. However, there is currently no research on the effects of combining sevoflurane and remimazolam for general anesthesia in adult patients on postoperative arousal and recovery.
The objective of this study is to investigate whether there is a difference in the time to emergence from anesthesia and time to tracheal extubation in patients undergoing gynecologic and laparoscopic surgery under general anesthesia, comparing the concurrent administration of sevoflurane and remimazolam with the maintenance of anesthesia using sevoflurane alone.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane group, S group | No intervention | –The control group will maintain oxygen-air (O2-Air) at 2 L/min and adjust the concentration of sevoflurane to maintain the depth of anesthesia with a bispectral index (BIS) of 40-60. |
| Remimazolam/Sevoflurane group, RS group | Active comparator | Drug: RemimazolamAfter tracheal intubation, the experimental group will maintain oxygen-air (O2-Air) at 2 liters/minute, and remimazolam will be infused at 1.0mg/kg/h, while adjusting the concentration of sevoflurane to maintain the depth of anesthesia with a bispectral index (BIS) of 40-60. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients aged 19 to 70 undergoing gynecologic and laparoscopic surgery under general anesthesia
- Patients classified as American Society of Anesthesiologists (ASA) physical status classification I or II
- Class I - Healthy patients without systemic disease Class II - Patients with mild systemic disease without functional limitation Class III - Patients with severe systemic disease that limits activity but is not incapacitating Class IV - Patients with incapacitating systemic disease that is a constant threat to life Class V - Moribund patients who are not expected to survive without the operation Class VI - Brain-dead patients for organ donation
Key exclusion criteria (14 listed)
- Patients classified as ASA physical status classification III or above
- Pregnant women
- Patients with hypersensitivity to sevoflurane or other halogenated anesthetics, malignant hyperthermia, or a history of it in the patient or family
- Patients with preoperative impairment of consciousness or coma
- Patients undergoing emergency surgery or those who are hemodynamically unstable preoperatively
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: ByfavoAfter tracheal intubation, the experimental group will maintain oxygen-air (O2-Air) at 2 liters/minute, and remimazolam will be infused at 1.0mg/kg/h, while adjusting the concentration of sevoflurane to maintain the depth of anesthesia with a bispectral index (BIS) of 40-60. | Drug | Remimazolam/Sevoflurane group, RS group |
Primary outcome
time to emergence
Time frame: Immediate after the end of general anesthesia
A comparison will be made between the time to emergence from anesthesia in patients receiving concurrent administration of sevoflurane and remimazolam versus those maintained on sevoflurane alone after surgery.
time to tracheal extubation
Time frame: Immediate after the end of general anesthesia
A comparison will be made between the time to tracheal extubation in patients receiving concurrent administration of sevoflurane and remimazolam versus those maintained on sevoflurane alone after surgery.
5 secondary outcomes
usage of vasopressors
Time frame: During general anesthesia
severity of cough
Time frame: immediate after the end of general anesthesia
time to discharge from the recovery room
Time frame: immediate after entering the PACU until until achieving post-anesthesia recovery score of 9 or more
postoperative pain scores
Time frame: Immediate after entering the PACU, 15 minutes after entering the PACU
scores for postoperative nausea and vomiting
Time frame: Immediate after entering the PACU, 15 minutes after entering the PACU
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 1 Aug 2025.
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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.
Hee Young Kim, MD, PhD principal investigator
Department of Anesthesia and Pain Medicine, School of Medicine, Pusan National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam in people with Gynecological Surgery, run by Pusan National University Yangsan Hospital at 1 site 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 4 inclusion and 14 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 1 Aug 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 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?
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 to emergence (time frame: Immediate after the end of general anesthesia). The study lists 2 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 1 Aug 2025.