Knee OsteoarthritisNCT05322902
Remimazolam Total Intravenous Anesthesia Under Analgesia Nociception Index-guidance
A study testing remimazolam group and propofol group in people with Knee Osteoarthritis and Total Knee Arthroplasty, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
The investigators hypothesized that intraoperative opioid consumption would be different between remimazolam and propofol if the ANI-guided remifentanil continuous infusion rate was adjusted when the depth of anesthesia was maintained at similar depths with remimazolam or propofol under total intravenous anesthesia. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Total Knee Arthroplasty, Remimazolam
- What is being tested?
- remimazolam group and propofol group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jun 2022to 18 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 19~80 years of age who are expected to elective total knee arthroplasty under general anesthesia
- ASA PS 1-3
Who cannot join
- Second total knee arthroplasty under a prior plan of staged total knee arthroplasty, both
- Previous hepatectomy or liver transplant
- Estimated glomerular filtration rate < 30 mL/min/1.73m2
- Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal)
- Uncontrolled hypertension (systolic blood pressure > 160mmHg)
- Acute narrow angle glaucoma
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- Myasthesia gravis
- Known allergy to the drugs included in the study
- Cardiac arrhthmia (non-sinus rhythm)
- Taking drugs that affect the autonomic nervous system of diabetes
- Psychiatric or neurologic disease (major depression disorder, dementia or cerebral infarction)
- History of drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intraoperative Remifentanil Requirements During Remimazolam Versus Propofol Total Intravenous Anesthesia With Analgesia Nociception Index-guided Remifentanil Administration: a Randomized Controlled Study
The investigators hypothesized that intraoperative opioid consumption would be different between remimazolam and propofol if the ANI-guided remifentanil continuous infusion rate was adjusted when the depth of anesthesia was maintained at similar depths with remimazolam or propofol under total intravenous anesthesia. The purpose of this study is to compare the intraoperative remifentanil requirement in patients undergoing total knee arthroplasty when the intraoperative remifentanil dose adjustment was performed under the ANI guidance while maintaining a similar depth of anesthesia with remimazolam or propofol.
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplasty, Remimazolam
- Being tested
- remimazolam group, propofol group
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remimazolam groupDrug
Remimazolam 6 mg/kg/hr is administered as an intravenous infusion until the patient loses consciousness. Anesthesia is maintained at 1 mg/kg/hr of remimazolam. After confirming that the eyelash reflex disappears, rocuronium 0.8 mg/kg is administered, and SGA insertion is performed. During maintenance of general anesthesia, the concentration of remifentanil is continuously adjusted so that the ANI is above 50.
propofol groupDrug
Propofol intravenous infusion is initiated by the application of a target concentration infusion (TCI) pump to cause the patient to lose consciousness. After confirming that the eyelash reflex disappears, rocuronium 0.8 mg/kg is administered, and SGA insertion is performed. During maintenance of general anesthesia, the concentration of remifentanil is continuously adjusted so that the ANI is above 50.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam group | Experimental | Total intravenous anesthesia with remimazolam and remifentanil Receives: Drug: remimazolam group |
| Propofol group | Active comparator | Total intravenous anesthesia with propofol and remifentanil Receives: Drug: propofol group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative remifentanil consumption (mcg/kg/min)
At the start of anesthesia induction, intravenous remifentanil infusion is started and the intraoperative remifentanil infusion rate is adjusted based on the ANI 50 during surgery. The total dose of remifentanil infused intraoperatively is recorded.
Measured: Day 0, intraoperative
Secondary outcomes (2)
Numeric rating scale pain score at rest
Pain intensity at rest will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) 1, 6, 24 hours after the surgery.
Measured: up to 24 hours after the surgery
Postoperative opioid consumption
Postoperative opioid consumption
Measured: up to 24 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start2 Jun 2022
- Primary completion10 Jul 2023
- Study completion18 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Do-Hyeong Kim, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322902
- Sponsor's protocol ID
- 3-2022-0039
- Status last verified
- Jul 2023
- First submitted
- 4 Apr 2022
- Last updated
- 19 Jul 2023
- 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 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraoperative Remifentanil Requirements During Remimazolam Versus Propofol Total Intravenous Anesthesia With Analgesia Nociception Index-guided Remifentanil Administration: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05322902
- Acronym / sponsor ID
- 3-2022-0039
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplasty, Remimazolam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 18 Jul 2023 (actual)
- First posted
- 12 Apr 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.
The investigators hypothesized that intraoperative opioid consumption would be different between remimazolam and propofol if the ANI-guided remifentanil continuous infusion rate was adjusted when the depth of anesthesia was maintained at similar depths with remimazolam or propofol under total intravenous anesthesia. The purpose of this study is to compare the intraoperative remifentanil requirement in patients undergoing total knee arthroplasty when the intraoperative remifentanil dose adjustment was performed under the ANI guidance while maintaining a similar depth of anesthesia with remimazolam or propofol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam group | Experimental | Drug: remimazolam groupTotal intravenous anesthesia with remimazolam and remifentanil |
| Propofol group | Active comparator | Drug: propofol groupTotal intravenous anesthesia with propofol and remifentanil |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 19~80 years of age who are expected to elective total knee arthroplasty under general anesthesia
- ASA PS 1-3
Key exclusion criteria (12 listed)
- Second total knee arthroplasty under a prior plan of staged total knee arthroplasty, both
- Previous hepatectomy or liver transplant
- Estimated glomerular filtration rate < 30 mL/min/1.73m2
- Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal)
- Uncontrolled hypertension (systolic blood pressure > 160mmHg)
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 groupRemimazolam 6 mg/kg/hr is administered as an intravenous infusion until the patient loses consciousness. Anesthesia is maintained at 1 mg/kg/hr of remimazolam. After confirming that the eyelash reflex disappears, rocuronium 0.8 mg/kg is administered, and SGA insertion is performed. During maintenance of general anesthesia, the concentration of remifentanil is continuously adjusted so that the ANI is above 50. | Drug | Remimazolam group |
| propofol groupPropofol intravenous infusion is initiated by the application of a target concentration infusion (TCI) pump to cause the patient to lose consciousness. After confirming that the eyelash reflex disappears, rocuronium 0.8 mg/kg is administered, and SGA insertion is performed. During maintenance of general anesthesia, the concentration of remifentanil is continuously adjusted so that the ANI is above 50. | Drug | Propofol group |
Primary outcome
Intraoperative remifentanil consumption (mcg/kg/min)
Time frame: Day 0, intraoperative
At the start of anesthesia induction, intravenous remifentanil infusion is started and the intraoperative remifentanil infusion rate is adjusted based on the ANI 50 during surgery. The total dose of remifentanil infused intraoperatively is recorded.
2 secondary outcomes
Numeric rating scale pain score at rest
Time frame: up to 24 hours after the surgery
Postoperative opioid consumption
Time frame: up to 24 hours after the surgery
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 19 Jul 2023.
- 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?
A study testing remimazolam group and propofol group in people with Knee Osteoarthritis and Total Knee Arthroplasty, run by Gangnam Severance 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 2 inclusion and 12 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 19 Jul 2023. 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?
Intraoperative remifentanil consumption (mcg/kg/min) (time frame: Day 0, intraoperative). 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 19 Jul 2023.