HypotensionNCT05375747
Remimazolam Versus Propopol Based Total Intravenous Anesthesia for Breast Surgery
A study testing Remimazolam and Propofol in people with Hypotension, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Comparison of the incidence of hypotension under remimazolam and propofol-based anesthesia in patients undergoing breast surgery under general anesthesia Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- 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
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jun 2022to 9 Jan 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients over the age of 19 undergoing elective breast cancer surgery under general anesthesia at Seoul National University Hospital
Who cannot join
- patients with acute narrow-angle glaucoma/ shock or coma/ acute alcohol poisoning/ sleep apnea/ alcohol or drug dependency/ severe or acute respiratory failure/ galactose intolerance/ Lapp lactase deficiency/ glucose galactose malabsorption/ severe hypersensitivity to dextran.
- Patients with myasthenia gravis/ pulmonary heart disease/ chronic obstructive pulmonary disease/ bronchial asthma
- Patients with cardiovascular diseases such as ischemic heart disease/ coronary artery disease/ angina pectoris/ myocardial infarction/ atherosclerosis/ arrhythmia/ cerebrovascular disease/ and stroke
- Patients with chronic renal failure
- Patients with severe hepatic impairment (Child Pugh class C)
- Patients with American Society of Anesthesiology score III or higher
Show all 13Show fewer
- Patients with hypersensitivity to propofol and soy or peanuts
- Epilepsy patients
- Patient with fat metabolism abnormality
- Patients with high intracranial pressure
- Pregnant woman
- Patients unable to use supraglottic airway due to poor dental condition
- In cases that the researcher judges to be unsuitable for this clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Remimazolam Versus Propopol Based Total Intravenous Anesthesia for Breast Surgery : a Randomized Controlled Trial
Comparison of the incidence of hypotension under remimazolam and propofol-based anesthesia in patients undergoing breast surgery under general anesthesia
Read the detailed description
The purpose of this study was to investigate whether remimazolam-based general anesthesia could reduce the incidence of hypotension in patients undergoing breast surgery under general anesthesia compared to propofol-based general anesthesia. The purpose of this study is to establish and test the hypothesis that the incidence of hypotension under general anesthesia based on remimazolam will be less than that of propofol based general anesthesia. In addition, this study compares the proportion of patients who require a vasopressor, the time taken for anesthesia induction, the time to recover from anesthesia, postoperative pain, the incidence of postoperative nausea and vomiting, the quality of postoperative recovery, and patient satisfaction.
- Conditions
- Hypotension
- Being tested
- 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.
RemimazolamDrug
For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of remimazolam and remifentanil.
PropofolDrug
For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of propofol and remifentanil.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam based total intravenous anesthesia | Experimental | For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of remimazolam and remifentanil. Receives: Drug: Remimazolam |
| Propofol based total intravenous anesthesia | Active comparator | For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of propofol and remifentanil. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotension incidence
Incidence of hypotension (MAP <65 mmHg) from induction of anesthesia to end of surgery
Measured: from induction of anesthesia to end of surgery
Secondary outcomes (26)
Use of vasopressor
Proportion of patients using vasopressors due to hypotension from induction of anesthesia to completion of surgery
Measured: from induction of anesthesia to end of surgery
Number of occurrences of hypotension during surgery
Number of occurrences of hypotension during surgery
Measured: from induction of anesthesia to end of surgery
Type of vasopressor used
Type of vasopressor used
Measured: from induction of anesthesia to end of surgery
Total dose of vasopressor used
Total dose of vasopressor used
Measured: from induction of anesthesia to end of surgery
Blood pressure
Blood pressure during operation, noninvasive blood pressure is measured at lower leg
Measured: from induction of anesthesia to end of surgery
Heart rate
Heart rate during operation
Measured: from induction of anesthesia to end of surgery
Saturation of percutaneous oxygen (SpO2)
Saturation of percutaneous oxygen (SpO2) during operation
Measured: from induction of anesthesia to end of surgery
Patient State Index (PSi)
Patient State Index (PSi) during operation
Measured: from induction of anesthesia to end of surgery
Incidence of bradycardia
Incidence of bradycardia during operation, bradycardia is defined as heart rate less than 50
Measured: from induction of anesthesia to end of surgery
Severity of injection pain
Severity of injection pain of sedative(propofol or remimazolam depending on group assignment) during induction of anethesia: none/ mild/ moderate/ severe
Measured: At the start of induction of general anesthesia
Incidence of intraoperative awareness
Incedence of intraoperative awareness during operation
Measured: from induction of anesthesia to end of surgery
Incidence of intraoperative body movement
Incidence of intraoperative body movement during operation
Measured: from induction of anesthesia to end of surgery
Incidence of use of rescue sedative agents
Incidence of use of any kinds of rescue sedative agents
Measured: from induction of anesthesia to end of surgery
T ime from start of administration of sedative drug to loss of consciousness
T ime from start of administration of sedative drug to loss of consciousness
Measured: from induction of anesthesia to loss of consciousness
Time from the end of administration of sedative to eye opening
Time from the end of administration of sedative(propofol or remimazolam depending on group assignment) to eye opening
Measured: from end of administration of sedative to eye opening
Time from the end of administration of sedative to response to verbal command
Time from the end of administration of sedative(propofol or remimazolam depending on group assignment) to response to verbal command
Measured: from end of administration of sedative to response to verbal command
Time from the end of administration of sedative to supraglottic airway removal
Time from the end of administration of sedative(propofol or remimazolam depending on group assignment) to supraglottic airway removal
Measured: from end of administration of sedative to supraglottic airway removal
Duration of post anesthesia care unit stay
Duration of post anesthesia care unit stay
Measured: From entering post anesthesia care unit until leaving, post-operatively 1 hour average
Total analgesic consumption for 24 hours after surgery
Total analgesic consumption for 24 hours after surgery
Measured: For 24 hours after the end of surgery
Numeric rating scale score in the recovery room immediately after surgery
Numeric rating scale score in the recovery room immediately after surgery, Numeric rating scale: 0 points for no pain, 10 points for the worst pain imaginable / The higher the number, the more severe the pain
Measured: Immediate after end of surgery
Incidence of nausea and vomiting within 24 hours after surgery
Incidence of nausea and vomiting within 24 hours after surgery
Measured: within 24 hours after surgery
Severity of nausea and vomiting within 24 hours after surgery
Severity of nausea and vomiting within 24 hours after surgery: none,. mild, moderate, severe
Measured: within 24 hours after surgery
Subjective sleep quality on the day of surgery
Subjective sleep quality on the day of surgery, Score out of 10, the higher the number, the better the quality of sleep
Measured: During the day of surgery
Patient satisfaction with anesthesia
Patient satisfaction with anesthesia, Score out of 10, the higher the number, the better the quality of sleep
Measured: The day of operation
Hospital length of stay
Hospital length of stay
Measured: From administration to discharge, average 4 days
15 item Quality of Recovery
15 item Quality of Recovery: 15-item questionnaire about the degree of recovery after surgery, 10 points per question, total 150 points
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start13 Jun 2022
- Primary completion9 Jan 2023
- Study completion9 Jan 2023
Why it stopped: Unable to recruit participants due to hospital conditions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seokha Yoo, Seoul National University Hospital
- Investigators
- Seokha Yoo, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375747
- Sponsor's protocol ID
- 2112-150-1286
- Status last verified
- Nov 2024
- First submitted
- 6 May 2022
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Remimazolam Versus Propopol Based Total Intravenous Anesthesia for Breast Surgery : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05375747
- Acronym / sponsor ID
- 2112-150-1286
- Conditions
- Hypotension
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit participants due to hospital conditions
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 9 Jan 2023 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 17 May 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.
Comparison of the incidence of hypotension under remimazolam and propofol-based anesthesia in patients undergoing breast surgery under general anesthesia
Detailed description
The purpose of this study was to investigate whether remimazolam-based general anesthesia could reduce the incidence of hypotension in patients undergoing breast surgery under general anesthesia compared to propofol-based general anesthesia. The purpose of this study is to establish and test the hypothesis that the incidence of hypotension under general anesthesia based on remimazolam will be less than that of propofol based general anesthesia. In addition, this study compares the proportion of patients who require a vasopressor, the time taken for anesthesia induction, the time to recover from anesthesia, postoperative pain, the incidence of postoperative nausea and vomiting, the quality of postoperative recovery, and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam based total intravenous anesthesia | Experimental | Drug: RemimazolamFor induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of remimazolam and remifentanil. |
| Propofol based total intravenous anesthesia | Active comparator | Drug: PropofolFor induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of propofol and remifentanil. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients over the age of 19 undergoing elective breast cancer surgery under general anesthesia at Seoul National University Hospital
Key exclusion criteria (13 listed)
- patients with acute narrow-angle glaucoma/ shock or coma/ acute alcohol poisoning/ sleep apnea/ alcohol or drug dependency/ severe or acute respiratory failure/ galactose intolerance/ Lapp lactase deficiency/ glucose galactose malabsorption/ severe hypersensitivity to dextran.
- Patients with myasthenia gravis/ pulmonary heart disease/ chronic obstructive pulmonary disease/ bronchial asthma
- Patients with cardiovascular diseases such as ischemic heart disease/ coronary artery disease/ angina pectoris/ myocardial infarction/ atherosclerosis/ arrhythmia/ cerebrovascular disease/ and stroke
- Patients with chronic renal failure
- Patients with severe hepatic impairment (Child Pugh class C)
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 |
|---|---|---|
| RemimazolamFor induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of remimazolam and remifentanil. | Drug | Remimazolam based total intravenous anesthesia |
| PropofolFor induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of propofol and remifentanil. | Drug | Propofol based total intravenous anesthesia |
Primary outcome
Hypotension incidence
Time frame: from induction of anesthesia to end of surgery
Incidence of hypotension (MAP <65 mmHg) from induction of anesthesia to end of surgery
26 secondary outcomes
Use of vasopressor
Time frame: from induction of anesthesia to end of surgery
Number of occurrences of hypotension during surgery
Time frame: from induction of anesthesia to end of surgery
Type of vasopressor used
Time frame: from induction of anesthesia to end of surgery
Total dose of vasopressor used
Time frame: from induction of anesthesia to end of surgery
Blood pressure
Time frame: from induction of anesthesia to end of surgery
Heart rate
Time frame: from induction of anesthesia to end of surgery
Saturation of percutaneous oxygen (SpO2)
Time frame: from induction of anesthesia to end of surgery
Patient State Index (PSi)
Time frame: from induction of anesthesia to end of surgery
Incidence of bradycardia
Time frame: from induction of anesthesia to end of surgery
Severity of injection pain
Time frame: At the start of induction of general anesthesia
Incidence of intraoperative awareness
Time frame: from induction of anesthesia to end of surgery
Incidence of intraoperative body movement
Time frame: from induction of anesthesia to end of surgery
Incidence of use of rescue sedative agents
Time frame: from induction of anesthesia to end of surgery
T ime from start of administration of sedative drug to loss of consciousness
Time frame: from induction of anesthesia to loss of consciousness
Time from the end of administration of sedative to eye opening
Time frame: from end of administration of sedative to eye opening
Time from the end of administration of sedative to response to verbal command
Time frame: from end of administration of sedative to response to verbal command
Time from the end of administration of sedative to supraglottic airway removal
Time frame: from end of administration of sedative to supraglottic airway removal
Duration of post anesthesia care unit stay
Time frame: From entering post anesthesia care unit until leaving, post-operatively 1 hour average
Total analgesic consumption for 24 hours after surgery
Time frame: For 24 hours after the end of surgery
Numeric rating scale score in the recovery room immediately after surgery
Time frame: Immediate after end of surgery
Incidence of nausea and vomiting within 24 hours after surgery
Time frame: within 24 hours after surgery
Severity of nausea and vomiting within 24 hours after surgery
Time frame: within 24 hours after surgery
Subjective sleep quality on the day of surgery
Time frame: During the day of surgery
Patient satisfaction with anesthesia
Time frame: The day of operation
Hospital length of stay
Time frame: From administration to discharge, average 4 days
15 item Quality of Recovery
Time frame: 24 hours after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
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Hypotension
RecruitingPhase 4
Remimazolam Versus Propofol for Maintenance of Anaesthesia During Major Hepatectomy Under Low Central Venous Pressure
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Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruitingObservational study
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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.
Seokha Yoo principal investigator
Seoul National University Hospital
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 and Propofol in people with Hypotension, run by Seoul National University 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 1 inclusion and 13 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: withdrawn, as of the sponsor's last update on 29 Nov 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Hypotension incidence (time frame: from induction of anesthesia to end of surgery). 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 29 Nov 2024.