Myoma;UterusNCT05025410
Remimazolam and Remifentanil Without Neuromuscular Blocking Agent
An observational study of Myoma;Uterus and Polyp Endometrium, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Remimazolam is a novel drug approved for induction and maintenance of general anesthesia. This study aims to check the appropriate dose and patient response by administering remimazolam and remifentanil in surgery that does not require a neuromuscular blocking agents. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Myoma;Uterus, Polyp Endometrium, Unspecified Condition Associated With Female Genital Organs and Menstrual Cycle
- What is being tested?
- Remimazolam
- Type of treatment
- Injection or infusion
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2021to 31 Jan 2022
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult woman scheduled for gynecological surgery under general anesthesia
Who may be able to join
- Adult woman scheduled for gynecological surgery under general anesthesia
- American Society of Anesthesiology grade 1 or 2
- When using a laryngeal mask airway to maintain general anesthesia
Who cannot join
- Underlying diseases: liver, kidney, brain nervous system, glaucoma
- Patients with BMI greater than 30 and less than 18.5
- Patients diagnosed with sleep apnea
- Alcohol or drug dependent patients
- Patients with severe or acute respiratory failure
- Lactose intolerance
- Dextran 40 hypersensitivity
- Patients in shock or coma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: General Anesthesia Using Remimazolam and Remifentanil Without Neuromuscular Blocking Agent: Prospective Observational Study
Remimazolam is a novel drug approved for induction and maintenance of general anesthesia. This study aims to check the appropriate dose and patient response by administering remimazolam and remifentanil in surgery that does not require a neuromuscular blocking agents.
- Conditions
- Myoma;Uterus, Polyp Endometrium, Unspecified Condition Associated With Female Genital Organs and Menstrual Cycle
- Being tested
- Remimazolam
- Medical subject headings
- Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Loading for anesthesia induction: Remimazolam 6 mg/kg/h until loss of consciousness Continuous infusion for anesthesia maintenance: Remimazolam 1-2 mg/kg/h under the Bispectral index monitoring
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia using remimazolam and remifentanil | Adult female patients scheduled for gynecological surgery under general anesthesia using remimazolam and remifentanil Receives: Drug: Remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remimazolam induction dose
Measured: During the anesthesia induction (from initiation of anesthesia until the insertion of laryngeal mask airway)
Remimazolam maintenance dose
Measured: During the anesthesia maintenance (from the insertion of laryngeal mask airway until stopping remimazolam infusion)
Secondary outcomes (3)
Use of rescue midazolam
Measured: During the anesthesia (from initiation of anesthesia until stopping remimazolam infusion)
Use of rescue rocuronium
Measured: During the anesthesia (from initiation of anesthesia until stopping remimazolam infusion)
Use of flumazenil
Measured: During the anesthesia recovery (from stopping remimazolam infusion until the recovery of consciousness)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 Nov 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
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 Myoma;UterusStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025410
- Sponsor's protocol ID
- B-2109-706-301
- Status last verified
- Apr 2022
- First submitted
- 23 Aug 2021
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park I, Cho M, Nam SW, Hwang JW, Do SH, Na HS. Total intravenous anesthesia induced and maintained by a combination of remimazolam and remifentanil without a neuromuscular blocking agent: a prospective, observational pilot study. BMC Anesthesiol. 2022 Jul 26;22(1):237. doi: 10.1186/s12871-022-01779-2.
PubMed 35883039
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Anesthesia Using Remimazolam and Remifentanil Without Neuromuscular Blocking Agent: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05025410
- Acronym / sponsor ID
- B-2109-706-301
- Conditions
- Myoma;Uterus, Polyp Endometrium, Unspecified Condition Associated With Female Genital Organs and Menstrual Cycle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 27 Aug 2021 (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.
Remimazolam is a novel drug approved for induction and maintenance of general anesthesia. This study aims to check the appropriate dose and patient response by administering remimazolam and remifentanil in surgery that does not require a neuromuscular blocking agents.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General anesthesia using remimazolam and remifentanil | – | Drug: RemimazolamAdult female patients scheduled for gynecological surgery under general anesthesia using remimazolam and remifentanil |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult woman scheduled for gynecological surgery under general anesthesia
Key inclusion criteria (3 listed)
- Adult woman scheduled for gynecological surgery under general anesthesia
- American Society of Anesthesiology grade 1 or 2
- When using a laryngeal mask airway to maintain general anesthesia
Key exclusion criteria (8 listed)
- Underlying diseases: liver, kidney, brain nervous system, glaucoma
- Patients with BMI greater than 30 and less than 18.5
- Patients diagnosed with sleep apnea
- Alcohol or drug dependent patients
- Patients with severe or acute respiratory failure
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 |
|---|---|---|
| RemimazolamLoading for anesthesia induction: Remimazolam 6 mg/kg/h until loss of consciousness Continuous infusion for anesthesia maintenance: Remimazolam 1-2 mg/kg/h under the Bispectral index monitoring | Drug | General anesthesia using remimazolam and remifentanil |
Primary outcome
Remimazolam induction dose
Time frame: During the anesthesia induction (from initiation of anesthesia until the insertion of laryngeal mask airway)
Remimazolam maintenance dose
Time frame: During the anesthesia maintenance (from the insertion of laryngeal mask airway until stopping remimazolam infusion)
3 secondary outcomes
Use of rescue midazolam
Time frame: During the anesthesia (from initiation of anesthesia until stopping remimazolam infusion)
Use of rescue rocuronium
Time frame: During the anesthesia (from initiation of anesthesia until stopping remimazolam infusion)
Use of flumazenil
Time frame: During the anesthesia recovery (from stopping remimazolam infusion until the recovery of consciousness)
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 25 Apr 2022.
- Derived from this study: PubMed 35883039Park I, Cho M, Nam SW, Hwang JW, Do SH, Na HS. Total intravenous anesthesia induced and maintained by a combination of remimazolam and remifentanil without a neuromuscular blocking agent: a prospective, observational pilot study. BMC Anesthesiol. 2022 Jul 26;22(1):237. doi: 10.1186/s12871-022-01779-2.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myoma;Uterus and Polyp Endometrium, run by Seoul National University Bundang 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 3 inclusion and 8 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 25 Apr 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?
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?
Remimazolam induction dose (time frame: During the anesthesia induction (from initiation of anesthesia until the insertion of laryngeal mask airway)). 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?
On the ClinicalTrials.gov record for NCT05025410, 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 25 Apr 2022.