Adult Patients 19 or Older Scheduled for Elective Arthroscopic MeniscectomyNCT05280236
Comparison of Quality of Recovery Between Remimazolam and Propofol Anesthesia in Patients Undergoing Arthroscopic Meniscectomy
A study testing Propofol TIVA and Remimazolam TIVA in people with Adult Patients 19 or Older Scheduled for Elective Arthroscopic Meniscectomy, run by Yonsei University at 1 site in South Korea.
Trial summary
This study aims to compare quality of recovery after surgery and anesthesia between patients undergoing arthroscopic meniscectomy under general anesthesia with either propofol or remimazolam based total intravenous anesthesia. This study is a randomized trial with a 50% probability of being assigned to either group. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Adult Patients 19 or Older Scheduled for Elective Arthroscopic Meniscectomy
- What is being tested?
- Propofol TIVA and Remimazolam TIVA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Mar 2022to 30 Apr 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients 19 or older, ASA class I~III,
- scheduled for arthroscopic meniscectomy under general anesthesia and eligible for LMA use.
Who cannot join
- Patient refusal,
- patients unable to read consent form, active URI or uncontrolled asthma,
- pneumonia,
- history of allergies to propofol or benzodiazepines,
- decreased liver or kidney function, heart failure of ejection fraction<55%,
- pregnant or breastfeeding patients,
- history of substance abuse/addiction
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
This study aims to compare quality of recovery after surgery and anesthesia between patients undergoing arthroscopic meniscectomy under general anesthesia with either propofol or remimazolam based total intravenous anesthesia. This study is a randomized trial with a 50% probability of being assigned to either group. Randomization will be done by an anesthesiologist not involved in anesthesia or postoperative outcome assessment. Patients and the investigator in charge of postoperative outcomes assessment will be blinded to group allocation.
- Being tested
- Propofol TIVA, Remimazolam TIVA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol TIVADrug
Patients will receive propofol-based TIVA with propofol and remifentanil TCI (target controlled infusion)
Remimazolam TIVADrug
Patients will receive remimazolam-based TIVA with remimazolam infusion and remifentanil TCI
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | Patients receiving general anesthesia with propofol-based total intravenous anesthesia Receives: Drug: Propofol TIVA |
| Remimazolam | Experimental | Patients receiving general anesthesia with remimazolam-based total intravenous anesthesia Receives: Drug: Remimazolam TIVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery (QoR)-40 questionnaire
Quality of recovery assessed with the QoR-40 questionnaire, which is a widely-used, self-rated, self-completed questionnaire for postoperative patients.
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start14 Mar 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Patients 19 or Older Scheduled for Elective Arthroscopic MeniscectomyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280236
- Sponsor's protocol ID
- 4-2021-1803
- Status last verified
- Jul 2024
- First submitted
- 6 Mar 2022
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Quality of Recovery Between Remimazolam and Propofol Anesthesia in Patients Undergoing Arthroscopic Meniscectomy
- ClinicalTrials.gov ID
- NCT05280236
- Acronym / sponsor ID
- 4-2021-1803
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 15 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.
This study aims to compare quality of recovery after surgery and anesthesia between patients undergoing arthroscopic meniscectomy under general anesthesia with either propofol or remimazolam based total intravenous anesthesia. This study is a randomized trial with a 50% probability of being assigned to either group. Randomization will be done by an anesthesiologist not involved in anesthesia or postoperative outcome assessment. Patients and the investigator in charge of postoperative outcomes assessment will be blinded to group allocation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: Propofol TIVAPatients receiving general anesthesia with propofol-based total intravenous anesthesia |
| Remimazolam | Experimental | Drug: Remimazolam TIVAPatients receiving general anesthesia with remimazolam-based total intravenous anesthesia |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients 19 or older, ASA class I~III,
- scheduled for arthroscopic meniscectomy under general anesthesia and eligible for LMA use.
Key exclusion criteria (7 listed)
- Patient refusal,
- patients unable to read consent form, active URI or uncontrolled asthma,
- pneumonia,
- history of allergies to propofol or benzodiazepines,
- decreased liver or kidney function, heart failure of ejection fraction<55%,
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 |
|---|---|---|
| Propofol TIVAPatients will receive propofol-based TIVA with propofol and remifentanil TCI (target controlled infusion) | Drug | Propofol |
| Remimazolam TIVAPatients will receive remimazolam-based TIVA with remimazolam infusion and remifentanil TCI | Drug | Remimazolam |
Primary outcome
Quality of Recovery (QoR)-40 questionnaire
Time frame: Postoperative 24 hours
Quality of recovery assessed with the QoR-40 questionnaire, which is a widely-used, self-rated, self-completed questionnaire for postoperative patients.
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 8 Jul 2024.
- Individual participant dataSharing planned: No
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?
A study testing Propofol TIVA and Remimazolam TIVA in people with Adult Patients 19 or Older Scheduled for Elective Arthroscopic Meniscectomy, 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 2 inclusion and 7 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 8 Jul 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 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?
Quality of Recovery (QoR)-40 questionnaire (time frame: Postoperative 24 hours). 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 8 Jul 2024.