Orthopedic SurgeryNCT05298228
Dose Finding Study of Remimazolam for Laryngeal Mask Airway Insertion
A study testing Remimazolam bolus does administration in people with Orthopedic Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
Laryngeal mask airways (LMA) are widely used in patients receiving general anesthesia and are known to have the following advantages over the endotracheal tube: lower incidence of postoperative sore throat, lower incidence of cough during emergence, and lower incidence of postoperative vomiting. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Orthopedic Surgery
- What is being tested?
- Remimazolam bolus does administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2022to 27 Jul 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 19~65 year
- ASA class I~III
- Patients scheduled for orthopedic surgery under general anesthesia and eligible for LMA use.
Who cannot join
- Patient refusal
- Patients unable to read consent form
- Anticipated difficult mask ventilation
- Active URI or uncontrolled asthma
- Pneumonia
- Risk of aspiration such as GERD
Show all 11Show fewer
- History of allergies to benzodiazepines
- Decreased liver or kidney function
- Pregnant or breastfeeding patients
- BMI > 30kg/m2
- History of substance abuse/addiction
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
Seokyung Shin, 82-2-2228-5785, skshin@yuhs.ac
About this study
Laryngeal mask airways (LMA) are widely used in patients receiving general anesthesia and are known to have the following advantages over the endotracheal tube: lower incidence of postoperative sore throat, lower incidence of cough during emergence, and lower incidence of postoperative vomiting. Although LMAs can be inserted without the use of muscle relaxants, a sufficient depth of anesthesia is necessary for placement. Remimazolam is a newer anesthetic that is ultra-short acting with a rapid onset and short context-sensitive half-life allowing for fast recovery. However, the dose of remimazolam needed for LMA insertion without muscle relaxants is not well known. This dose-finding study aims to find the ED50 and ED95 of a single bolus dose of remimazolam for LMA insertion without muscle relaxants in adult patients.
This is an interventional study done in a single group using the Dixon's up-and-down method which requires at least six success/failure pairs in the same direction. The primary endpoint of this study is to investigate the dose of remimazolam associated with 50% (ED50) and 95% (ED95) probability for adequate depth of anesthesia for LMA insertion without muscle relaxants. The beginning dose of remimazolam is 0.3 mg/kg, and when LMA insertion is successful, the dose will be decreased by 0.05 mg/kg in the next patient. When LMA insertion is unsuccessful (failed), the dose will be increased by 0.05 mg/kg in the next patient. Successful LMA insertion is defined as symmetrical chest wall movement and square-wave capnographic traces observed with manual ventilation.
- Conditions
- Orthopedic Surgery
- Being tested
- Remimazolam bolus does administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam bolus does administrationDrug
The beginning dose of remimazolam is 0.3 mg/kg, and when LMA insertion is successful, the dose will be decreased by 0.05 mg/kg in the next patient. When LMA insertion is unsuccessful (failed), the dose will be increased by 0.05 mg/kg in the next patient.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam | Experimental | A bolus dose of remimazolam is administered to facilitate LMA insertion Receives: Drug: Remimazolam bolus does administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of remimazolam associated with 50% (ED50) probability for adequate depth of anesthesia for LMA insertion without muscle relaxants.
The primary outcome of this study will be determined based on the data of "success" or "failure" of LMA insertion at predetermined doses of remimazolam. Successful LMA insertion is defined as symmetrical chest wall movement and square-wave capnographic traces observed with manual ventilation which will be assessed immediately after LMA insertion attempt.
Measured: During procedure (Immediately after LMA insertion attempt)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study startMar 2022 (estimated)
- Primary completion26 Jul 2023 (estimated)
- Study completion27 Jul 2023 (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 Orthopedic SurgeryStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT05298228
- Sponsor's protocol ID
- 4-2021-1706
- Status last verified
- Mar 2022
- First submitted
- 6 Mar 2022
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho E, Roh YH, Moon J, Kim Y, Shin S. Effective bolus dose of remimazolam for i-gel(R) insertion in nonparalyzed patients: a dose-finding study. Can J Anaesth. 2024 Sep;71(9):1251-1260. doi: 10.1007/s12630-024-02762-w. Epub 2024 Apr 26.
PubMed 38671251
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Finding Study of Remimazolam for Laryngeal Mask Airway Insertion
- ClinicalTrials.gov ID
- NCT05298228
- Acronym / sponsor ID
- 4-2021-1706
- Conditions
- Orthopedic Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- 26 Jul 2023 (estimated)
- Study completion
- 27 Jul 2023 (estimated)
- First posted
- 28 Mar 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.
Laryngeal mask airways (LMA) are widely used in patients receiving general anesthesia and are known to have the following advantages over the endotracheal tube: lower incidence of postoperative sore throat, lower incidence of cough during emergence, and lower incidence of postoperative vomiting. Although LMAs can be inserted without the use of muscle relaxants, a sufficient depth of anesthesia is necessary for placement. Remimazolam is a newer anesthetic that is ultra-short acting with a rapid onset and short context-sensitive half-life allowing for fast recovery. However, the dose of remimazolam needed for LMA insertion without muscle relaxants is not well known. This dose-finding study aims to find the ED50 and ED95 of a single bolus dose of remimazolam for LMA insertion without muscle relaxants in adult patients.
This is an interventional study done in a single group using the Dixon's up-and-down method which requires at least six success/failure pairs in the same direction. The primary endpoint of this study is to investigate the dose of remimazolam associated with 50% (ED50) and 95% (ED95) probability for adequate depth of anesthesia for LMA insertion without muscle relaxants. The beginning dose of remimazolam is 0.3 mg/kg, and when LMA insertion is successful, the dose will be decreased by 0.05 mg/kg in the next patient. When LMA insertion is unsuccessful (failed), the dose will be increased by 0.05 mg/kg in the next patient. Successful LMA insertion is defined as symmetrical chest wall movement and square-wave capnographic traces observed with manual ventilation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remimazolam | Experimental | Drug: Remimazolam bolus does administrationA bolus dose of remimazolam is administered to facilitate LMA insertion |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients aged 19~65 year
- ASA class I~III
- Patients scheduled for orthopedic surgery under general anesthesia and eligible for LMA use.
Key exclusion criteria (11 listed)
- Patient refusal
- Patients unable to read consent form
- Anticipated difficult mask ventilation
- Active URI or uncontrolled asthma
- Pneumonia
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 bolus does administrationThe beginning dose of remimazolam is 0.3 mg/kg, and when LMA insertion is successful, the dose will be decreased by 0.05 mg/kg in the next patient. When LMA insertion is unsuccessful (failed), the dose will be increased by 0.05 mg/kg in the next patient. | Drug | Remimazolam |
Primary outcome
Dose of remimazolam associated with 50% (ED50) probability for adequate depth of anesthesia for LMA insertion without muscle relaxants.
Time frame: During procedure (Immediately after LMA insertion attempt)
The primary outcome of this study will be determined based on the data of "success" or "failure" of LMA insertion at predetermined doses of remimazolam. Successful LMA insertion is defined as symmetrical chest wall movement and square-wave capnographic traces observed with manual ventilation which will be assessed immediately after LMA insertion attempt.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- Derived from this study: PubMed 38671251Cho E, Roh YH, Moon J, Kim Y, Shin S. Effective bolus dose of remimazolam for i-gel(R) insertion in nonparalyzed patients: a dose-finding study. Can J Anaesth. 2024 Sep;71(9):1251-1260. doi: 10.1007/s12630-024-02762-w. Epub 2024 Apr 26.
- Individual participant dataSharing planned: No
Related trials for Orthopedic Surgery
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingObservational study
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
Preoperative Anxiety, Orthopedic Surgery
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruitingPhase 4
Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture
Hip Fractures (ICD-10 72.01-72.2), Post Operative Analgesia
Enrolling by invitationPhase 4
PPP Versus Corticosteroid for Thigh Muscle Injuries
Thigh Muscle Injury, Thigh Injury
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 bolus does administration in people with Orthopedic Surgery, 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 3 inclusion and 11 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 28 Mar 2022. 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 Seokyung Shin (82-2-2228-5785, skshin@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose of remimazolam associated with 50% (ED50) probability for adequate depth of anesthesia for LMA insertion without muscle relaxants. (time frame: During procedure (Immediately after LMA insertion attempt)). 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 NCT05298228, 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 28 Mar 2022.