Patients Undergoing Transurethral Resection of BladderNCT06217055
Comparison of Remimazolam-based MAC With Inhalation General Anesthesia Under the Guidance of an ANI Monitor During TURB
A study testing remimazolam based MAC and general anesthesia with sevoflurane in people with Patients Undergoing Transurethral Resection of Bladder, run by Yonsei University at 1 site in South Korea.
Trial summary
In patients undergoing transurethral resection of bladder, the effect of remimazolam-based monitored anesthesia care (MAC) and inhalational general anesthesia will be compared under guidance by analgesia nociception index (ANI) monitoring. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Patients Undergoing Transurethral Resection of Bladder
- What is being tested?
- remimazolam based MAC and general anesthesia with sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2024to Oct 2024
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing transurethral bladder resection
Who cannot join
- ASA class 4
- emergency surgery
- history of hypersensitivity to sevoflurane, propofol and remimazolam
- galactose intolerance
- patient refusal
- patients in whom muscular relaxation are needed.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei university college of medicine
Seoul
Jin Ha Park, 82-2-2228-2420, realsummer@yuhs.ac
About this study
Official title: Comparison of Remimazolam-based Monitored Anesthesia Care With Inhalation General Anesthesia Under the Guidance of an ANI Monitor During TURB: a Randomized Controlled Trial
In patients undergoing transurethral resection of bladder, the effect of remimazolam-based monitored anesthesia care (MAC) and inhalational general anesthesia will be compared under guidance by analgesia nociception index (ANI) monitoring. Anesthesia time, operation time, anesthesia time excluding operation time and total dose of opioid will be compared.
Read the detailed description
In remimazolam-based MAC group, anesthesia will be induced with remimazolam and spontaneous breathing will be maintained. The dose of remimazolam and remifentanil will be adjusted according to the patient state index (PSI) and the analgesia nociception index(ANI).
In inhalation general anesthesia group, anesthesia will be induced with propofol and rocuronium and maintained with sevoflurane and remifentanil. Mechanical ventilation will be maintained by inserting laryngeal mask airway (LMA) or endotracheal tube. The doses of sevoflurane and remifentanil will be adjusted according to the patient state index (PSI) and the analgesia nociception index(ANI).
Surgery cost, anesthesia cost, patient and surgeon's satisfaction score, pain score, PONV score and the incidence of hypotension and hypoxemia will be compared.
- Being tested
- remimazolam based MAC, general anesthesia with sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remimazolam based MACDrug
The surgery will be performed under monitored anesthesia care by maintaining spontaneous breathing using remimazolam.
general anesthesia with sevofluraneDrug
The surgery will be performed under mechanical ventilation with inhalation general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| remimazolam based MAC group | Experimental | remimazolam based monitored anesthesia care Receives: Drug: remimazolam based MAC |
| inhalation general anesthesia group | Active comparator | general anesthesia with sevoflurane Receives: Drug: general anesthesia with sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
anesthesia time excluding operation time
anesthesia time excluding operation time
Measured: 0-1 hour after the end of surgery (Time point at which patient exit the operating room)
Secondary outcomes (7)
surgery cost and anesthesia cost
surgery cost and anesthesia cost: insured cost and non-insured cost
Measured: 1 month after surgery
surgeon's satisfaction score
surgeon's satisfaction score: very poor (1)/ poor (2)/ satisfactory (3)/ good (4)/excellent (5)
Measured: At the end of surgery
patient's satisfaction score
patient's satisfaction score: very poor (1)/ poor (2)/ satisfactory (3)/ good (4)/excellent (5)
Measured: 0-2 hour after surgery (Time points at patient discharge from recovery room)
pain score
pain score : NRS 0-10 The numerical rating scale requires the patient to rate their pain or nausea/vomiting on a defined scale. Numerical rating scale (NRS) is the simplest and most commonly used scale. The numerical scale is most commonly 0 to 10, with 0 being "no pain or no nausea/vomiting" and 10 being "the worst pain or nausea/vomiting imaginable.
Measured: 0-2 hour after surgery (Time points at patient discharge from recovery room), and 6 hour after surgery
PONV score
PONV was defined as nausea or vomiting score.
Measured: 0-2 hour after surgery (Time points at patient discharge from recovery room), and 6 hour after surgery
incidence of hypotension
hypotension: baseline BP reduction (20%)
Measured: At the end of surgery
incidence of hypoxemia
hypoxemia : unresponsive to a jaw thrust maneuver and SPO2 <92%
Measured: At the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Transurethral Resection of BladderStudies of the same condition, open and under way.
- More trials run by Yonsei 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217055
- Sponsor's protocol ID
- 4-2023-1206
- Status last verified
- Jan 2024
- First submitted
- 22 Nov 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Remimazolam-based Monitored Anesthesia Care With Inhalation General Anesthesia Under the Guidance of an ANI Monitor During TURB: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06217055
- Acronym / sponsor ID
- 4-2023-1206
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 22 Jan 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.
In patients undergoing transurethral resection of bladder, the effect of remimazolam-based monitored anesthesia care (MAC) and inhalational general anesthesia will be compared under guidance by analgesia nociception index (ANI) monitoring. Anesthesia time, operation time, anesthesia time excluding operation time and total dose of opioid will be compared.
Detailed description
In remimazolam-based MAC group, anesthesia will be induced with remimazolam and spontaneous breathing will be maintained. The dose of remimazolam and remifentanil will be adjusted according to the patient state index (PSI) and the analgesia nociception index(ANI).
In inhalation general anesthesia group, anesthesia will be induced with propofol and rocuronium and maintained with sevoflurane and remifentanil. Mechanical ventilation will be maintained by inserting laryngeal mask airway (LMA) or endotracheal tube. The doses of sevoflurane and remifentanil will be adjusted according to the patient state index (PSI) and the analgesia nociception index(ANI).
Surgery cost, anesthesia cost, patient and surgeon's satisfaction score, pain score, PONV score and the incidence of hypotension and hypoxemia will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remimazolam based MAC group | Experimental | Drug: remimazolam based MACremimazolam based monitored anesthesia care |
| inhalation general anesthesia group | Active comparator | Drug: general anesthesia with sevofluranegeneral anesthesia with sevoflurane |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing transurethral bladder resection
Key exclusion criteria (6 listed)
- ASA class 4
- emergency surgery
- history of hypersensitivity to sevoflurane, propofol and remimazolam
- galactose intolerance
- patient refusal
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 |
|---|---|---|
| remimazolam based MACThe surgery will be performed under monitored anesthesia care by maintaining spontaneous breathing using remimazolam. | Drug | remimazolam based MAC group |
| general anesthesia with sevofluraneThe surgery will be performed under mechanical ventilation with inhalation general anesthesia | Drug | inhalation general anesthesia group |
Primary outcome
anesthesia time excluding operation time
Time frame: 0-1 hour after the end of surgery (Time point at which patient exit the operating room)
anesthesia time excluding operation time
7 secondary outcomes
surgery cost and anesthesia cost
Time frame: 1 month after surgery
surgeon's satisfaction score
Time frame: At the end of surgery
patient's satisfaction score
Time frame: 0-2 hour after surgery (Time points at patient discharge from recovery room)
pain score
Time frame: 0-2 hour after surgery (Time points at patient discharge from recovery room), and 6 hour after surgery
PONV score
Time frame: 0-2 hour after surgery (Time points at patient discharge from recovery room), and 6 hour after surgery
incidence of hypotension
Time frame: At the end of surgery
incidence of hypoxemia
Time frame: At the end of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 based MAC and general anesthesia with sevoflurane in people with Patients Undergoing Transurethral Resection of Bladder, run by Yonsei University 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 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: status not confirmed, as of the sponsor's last update on 22 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Ha Park (82-2-2228-2420, realsummer@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anesthesia time excluding operation time (time frame: 0-1 hour after the end of surgery (Time point at which patient exit the operating room)). 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 22 Jan 2024.