RemifentanilPhase 4NCT05876039
Optimal Dosage of Remifentanil for Vertebroplasty
A Phase 4 study testing Initial remifentanil effect-site concentration in people with Remifentanil and Analgesia, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
Percutaneous vertebroplasty has become a mainstay in the management of osteoporotic and malignant vertebral fractures. Procedural analgesia and sedation (PAS) with propofol and remifentanil may provides optimal hypnotic and analgesic effects. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Remifentanil, Analgesia
- What is being tested?
- Initial remifentanil effect-site concentration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 May 2023to 27 Dec 2024
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) score of I-III patients receiving percutaneous vertebroplasty under procedural sedation and analgesia with remifentanil and propofol
Who cannot join
- Age < 20 or > 80 years
- ASA classifications > III
- Pregnancy
- Known allergies to opioids, propofol or any drugs used in the study
- Emergency surgery
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Dosage of Remifentanil Infusion Combined With Propofol-based Total Intravenous Anesthesia in Percutaneous Vertebroplasty
Percutaneous vertebroplasty has become a mainstay in the management of osteoporotic and malignant vertebral fractures. Procedural analgesia and sedation (PAS) with propofol and remifentanil may provides optimal hypnotic and analgesic effects.
Read the detailed description
Percutaneous vertebroplasty has become a mainstay in the management of osteoporotic and malignant vertebral fractures. Many anesthetic methods have been used in percutaneous vertebroplasty; however, there is no gold-standard method. Procedural analgesia and sedation (PAS) are one of the commonly used approaches. For its unique properties, including rapid onset, precise intraoperative control, and a fast recovery profile, remifentanil is preferable to other opioids administration in a target-controlled infusion (TCI) pump. Combination of remifentanil with propofol may improve sedation experience; however, it can increase a risk of respiratory depression. Moreover, propofol and remifentanil are often administered with 2 TCI pumps to, respectively, provide hypnotic and analgesic effects, which together are considered to be an ideal anesthetic technique.
- Conditions
- Remifentanil, Analgesia
- Being tested
- Initial remifentanil effect-site concentration
- Keywords
- Vertebroplasty, Remifentanil, Target-controlled infusion, Procedural analgesia and sedation
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial remifentanil effect-site concentrationDrug
Different initial remifentanil effect-site concentration
| Study group | Role | What they receive |
|---|---|---|
| Group remifentanil of 1.0 ng/mL | Experimental | Initial remifentanil effect-site concentration of 1.0 ng/mL Receives: Drug: Initial remifentanil effect-site concentration |
| Group remifentanil 2.0 ng/mL | Active comparator | Initial remifentanil effect-site concentration of 2.0 ng/mL Receives: Drug: Initial remifentanil effect-site concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate analgesia at the time of the trocar needle insertion
Remaining moveless at the time of the trocar needle insertion
Measured: Time at the trocar needle placement
Adequate analgesia at the time of the bone cement injection
Remaining moveless at the time of the bone cement injection
Measured: Time at the bone cement injection
Secondary outcomes (7)
Hypotension at the time of the trocar needle placement
Mean blood pressure > 30% decrease from baseline
Measured: Time at the trocar needle placement
Hypotension at the time of the bone cement injection
Mean blood pressure > 30% decrease from baseline
Measured: Time at the bone cement injection
Apnea with desaturation at the time of the trocar needle placement
Oxygen saturation < 95%
Measured: Time at the trocar needle placement
Apnea with desaturation at the time of the bone cement injection
Oxygen saturation < 95%
Measured: Time at the bone cement injection
TCI pump adjustments at the time of the trocar needle placement
Frequency of TCI pump adjustments
Measured: Time at the trocar needle placement
TCI pump adjustments at the time of the bone cement injection
Frequency of TCI pump adjustments
Measured: Time at the bone cement injection
Numeric rating scale
Postoperative numeric rating scale. NRS scores is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible.
Measured: Postoperative one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start20 May 2023
- Primary completion24 Aug 2024
- Study completion27 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for RemifentanilStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei-Cheng Tseng, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876039
- Sponsor's protocol ID
- 210705163-V3
- Status last verified
- May 2023
- First submitted
- 3 May 2023
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Lai HC, Chen CL, Huang YH, Wu KL, Huang RC, Lin BF, Chan SM, Wu ZF. Comparison of 2 effect-site concentrations of remifentanil with midazolam during transrectal ultrasound-guided prostate biopsy under procedural analgesia and sedation: A randomized controlled study. Medicine (Baltimore). 2022 Sep 9;101(36):e30466. doi: 10.1097/MD.0000000000030466.
PubMed 36086764Lai HC, Tsai YT, Huang YH, Wu KL, Huang RC, Lin BF, Chan SM, Wu ZF. Comparison of 2 effect-site concentrations of remifentanil with midazolam during percutaneous transluminal balloon angioplasty under monitored anesthesia care: A randomized controlled study. Medicine (Baltimore). 2021 Jul 30;100(30):e26780. doi: 10.1097/MD.0000000000026780.
PubMed 34397727Cannata F, Spinoglio A, Di Marco P, Luzi M, Canneti A, Ricciuti G, Reale C. Total intravenous anesthesia using remifentanil in extracorporeal shock wave lithotripsy (ESWL). Comparison of two dosages: a randomized clinical trial. Minerva Anestesiol. 2014 Jan;80(1):58-65. Epub 2013 Jul 9.
PubMed 23839319
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Dosage of Remifentanil Infusion Combined With Propofol-based Total Intravenous Anesthesia in Percutaneous Vertebroplasty
- ClinicalTrials.gov ID
- NCT05876039
- Acronym / sponsor ID
- 210705163-V3
- Conditions
- Remifentanil, Analgesia
- Keywords
- Vertebroplasty, Remifentanil, Target-controlled infusion, Procedural analgesia and sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 20 May 2023 (actual)
- Primary completion
- 24 Aug 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 25 May 2023 (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.
Percutaneous vertebroplasty has become a mainstay in the management of osteoporotic and malignant vertebral fractures. Procedural analgesia and sedation (PAS) with propofol and remifentanil may provides optimal hypnotic and analgesic effects.
Detailed description
Percutaneous vertebroplasty has become a mainstay in the management of osteoporotic and malignant vertebral fractures. Many anesthetic methods have been used in percutaneous vertebroplasty; however, there is no gold-standard method. Procedural analgesia and sedation (PAS) are one of the commonly used approaches. For its unique properties, including rapid onset, precise intraoperative control, and a fast recovery profile, remifentanil is preferable to other opioids administration in a target-controlled infusion (TCI) pump. Combination of remifentanil with propofol may improve sedation experience; however, it can increase a risk of respiratory depression. Moreover, propofol and remifentanil are often administered with 2 TCI pumps to, respectively, provide hypnotic and analgesic effects, which together are considered to be an ideal anesthetic technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group remifentanil of 1.0 ng/mL | Experimental | Drug: Initial remifentanil effect-site concentrationInitial remifentanil effect-site concentration of 1.0 ng/mL |
| Group remifentanil 2.0 ng/mL | Active comparator | Drug: Initial remifentanil effect-site concentrationInitial remifentanil effect-site concentration of 2.0 ng/mL |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) score of I-III patients receiving percutaneous vertebroplasty under procedural sedation and analgesia with remifentanil and propofol
Key exclusion criteria (6 listed)
- Age < 20 or > 80 years
- ASA classifications > III
- Pregnancy
- Known allergies to opioids, propofol or any drugs used in the study
- Emergency surgery
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 |
|---|---|---|
| Initial remifentanil effect-site concentrationDifferent initial remifentanil effect-site concentration | Drug | Group remifentanil 2.0 ng/mL, Group remifentanil of 1.0 ng/mL |
Primary outcome
Adequate analgesia at the time of the trocar needle insertion
Time frame: Time at the trocar needle placement
Remaining moveless at the time of the trocar needle insertion
Adequate analgesia at the time of the bone cement injection
Time frame: Time at the bone cement injection
Remaining moveless at the time of the bone cement injection
7 secondary outcomes
Hypotension at the time of the trocar needle placement
Time frame: Time at the trocar needle placement
Hypotension at the time of the bone cement injection
Time frame: Time at the bone cement injection
Apnea with desaturation at the time of the trocar needle placement
Time frame: Time at the trocar needle placement
Apnea with desaturation at the time of the bone cement injection
Time frame: Time at the bone cement injection
TCI pump adjustments at the time of the trocar needle placement
Time frame: Time at the trocar needle placement
TCI pump adjustments at the time of the bone cement injection
Time frame: Time at the bone cement injection
Numeric rating scale
Time frame: Postoperative one hour
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 Jan 2025.
- Results publication: PubMed 36086764Lai HC, Chen CL, Huang YH, Wu KL, Huang RC, Lin BF, Chan SM, Wu ZF. Comparison of 2 effect-site concentrations of remifentanil with midazolam during transrectal ultrasound-guided prostate biopsy under procedural analgesia and sedation: A randomized controlled study. Medicine (Baltimore). 2022 Sep 9;101(36):e30466. doi: 10.1097/MD.0000000000030466.
- Results publication: PubMed 34397727Lai HC, Tsai YT, Huang YH, Wu KL, Huang RC, Lin BF, Chan SM, Wu ZF. Comparison of 2 effect-site concentrations of remifentanil with midazolam during percutaneous transluminal balloon angioplasty under monitored anesthesia care: A randomized controlled study. Medicine (Baltimore). 2021 Jul 30;100(30):e26780. doi: 10.1097/MD.0000000000026780.
- Results publication: PubMed 23839319Cannata F, Spinoglio A, Di Marco P, Luzi M, Canneti A, Ricciuti G, Reale C. Total intravenous anesthesia using remifentanil in extracorporeal shock wave lithotripsy (ESWL). Comparison of two dosages: a randomized clinical trial. Minerva Anestesiol. 2014 Jan;80(1):58-65. Epub 2013 Jul 9.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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 Phase 4 study testing Initial remifentanil effect-site concentration in people with Remifentanil and Analgesia, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
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: finished, as of the sponsor's last update on 8 Jan 2025. 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 Taiwan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Adequate analgesia at the time of the trocar needle insertion (time frame: Time at the trocar needle placement). 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 NCT05876039, which also lists 3 linked publications.
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 Jan 2025.