Fractures, CompressionNCT02476981
Comparison of Remifentanil and Dexmedetomidine for Monitored Anaesthesia Care During Vertebroplasty and Kyphoplasty
A study testing Remifentanil, Dexmedetomidine and midazolam in people with Fractures, Compression, run by Hallym University Medical Center at 1 site in South Korea.
Trial summary
This randomised, double-blind study compared remifentanil and dexmedetomidine for monitored anaesthesia care (MAC) during minimally invasive corrections of vertebral compression fracture (vertebroplasty (VP) and kyphoplasty (KP)). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fractures, Compression
- What is being tested?
- Remifentanil, Dexmedetomidine and midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to Oct 2014
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients who are scheduled for vertebroplasty or kyphoplasty under monitored anesthesia care
- ASA status I-III
- aged more than 65 years old.
Who cannot join
- obesity (BMI > 30 kg/m2)
- hypotension (systolic blood pressure < 100 mmHg)
- bradycardia (heart rate < 60 bpm)
- heart block
- baseline oxygen desaturation (SpO2 < 90%)
- sleep apnea
- asthma, or chronic obstructive pulmonary disease
- those who refused to give informed consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hallym University Sacred Heart Hospital
Anyang-si, Dongan-gu
About this study
Official title: Comparison of Remifentanil and Dexmedetomidine for Monitored Anaesthesia Care
This randomised, double-blind study compared remifentanil and dexmedetomidine for monitored anaesthesia care (MAC) during minimally invasive corrections of vertebral compression fracture (vertebroplasty (VP) and kyphoplasty (KP)).
In total, 80 ASA physical status I-III patients scheduled for VP and KP randomly received remifentanil or dexmedetomidine to maintain OAA/S scale ≤ 4 during the procedures. Multiple hemodynamic variables of patients were recorded and the frequency of oxygen desaturation, respiratory depression, intraoperative need for other opioids, recovery time, operator satisfaction score, and patients' overall pain experiences were also compared.
The investigators are expecting that both remifentanil and dexmedetomidine appear to be quite safe for MAC during VP and KP. Thus, dexmedetomidine may be an alternative for MAC during VP and KP in elderly patients.
Read the detailed description
All patients fasted for 8 h before the procedure and were premedicated with midazolam 0.02 mg/kg. In the prone position, patients were monitored by ECG, non-invasive blood pressure, and pulse oximetry, and received supplemental oxygen (3 L/min) via a nasal cannula during the procedure.
Study drugs were prepared in 20 mL and 50 mL syringes to maintain a double-blind design. One anaesthesiologist administered normal saline or dexmedetomidine contained in the 20-mL syringe during the initial 10 min for loading dose of dexmedetomidine. Then, another investigator who did not know which syringes contained remifentanil or dexmedetomidine adjusted the infusion rate with a 50-mL syringe according to patients' response. After all patients in both groups received a bolus dose of propofol 0.3 mg/kg, patients given remifentanil received continuous infusion of the drug at 1-5 µg/kg/h, and patients receiving dexmedetomidine were given that drug at 0.3-0.4 µg/kg over 10 min, followed by continuous infusion of dexmedetomidine 0.2-1 µg/kg/h throughout the procedure. Levels of patient sedation were checked during the procedure and infusion rates of the study drugs were adjusted to maintain alertness/sedation below 4 on the OAA/S scale.
Mean arterial pressure (MAP), heart rate (HR), oxygen saturation (SpO2), respiratory rate (RR), and adverse effects of the study drugs were recorded during the procedure. Ephedrine 5 mg was injected when systolic blood pressure decreased below 90 mmHg. Duration of PACU stay was also recorded.
Operator satisfaction score and patient's overall pain experience were also recorded.
- Conditions
- Fractures, Compression
- Being tested
- Remifentanil, Dexmedetomidine, midazolam, propofol, ephedrine
- Medical subject headings
- Fractures, Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called Ultiva
Patients given remifentanil received continuous infusion of the drug at 1-5 µg/kg/h
DexmedetomidineDrug
Also called Precedex
Patients receiving dexmedetomidine were given that drug at 0.3-0.4 µg/kg over 10 min, followed by continuous infusion of 0.2 1 µg/kg/h
midazolamDrug
All patients were premedicated with midazolam 0.02 mg/kg before induction.
propofolDrug
Also called Pofol
All patients in both groups received a bolus dose of propofol 0.3 mg/kg for sedative effect.
ephedrineDrug
Ephedrine 5 mg was injected when systolic blood pressure decreased below 90 mmHg
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil | Experimental | Remifentanil is commonly used in monitored anesthesia care because of its rapid onset and short duration of action. Receives: Drug: Remifentanil |
| Dexmedetomidine | Experimental | Dexmedetomidine is a highly selective α 2 adrenergic agonist and has both sedative and analgesic properties, and rarely causes respiratory depression. Receives: Drug: Dexmedetomidine |
| midazolam | Other | Midazolam is commonly used before induction for its anxiolytic effect. Receives: Drug: Remifentanil; Drug: Dexmedetomidine; Drug: midazolam |
| propofol | Other | Propofol is the most commonly used in sedative analgesia for its rapid onset and recovery time. Receives: Drug: Remifentanil; Drug: Dexmedetomidine; Drug: propofol |
| ephedrine | Other | Adrenergic agonist to treat hypotension Receives: Drug: Remifentanil; Drug: Dexmedetomidine; Drug: ephedrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequencies of oxygen desaturation during procedures
Measured: About 1 hour through the procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2015 (estimated)
- Study startAug 2012
- Primary completionJul 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Fractures, CompressionStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eun Young Park, MD, Study chair, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476981
- Sponsor's protocol ID
- 2012-I039
- Status last verified
- Jun 2015
- First submitted
- 16 Jun 2015
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Nevitt MC, Ettinger B, Black DM, Stone K, Jamal SA, Ensrud K, Segal M, Genant HK, Cummings SR. The association of radiographically detected vertebral fractures with back pain and function: a prospective study. Ann Intern Med. 1998 May 15;128(10):793-800. doi: 10.7326/0003-4819-128-10-199805150-00001.
PubMed 9599190Sen J, Sen B. A comparative study on monitored anesthesia care. Anesth Essays Res. 2014 Sep-Dec;8(3):313-8. doi: 10.4103/0259-1162.143121.
PubMed 25886327Ryu JH, Lee SW, Lee JH, Lee EH, Do SH, Kim CS. Randomized double-blind study of remifentanil and dexmedetomidine for flexible bronchoscopy. Br J Anaesth. 2012 Mar;108(3):503-11. doi: 10.1093/bja/aer400. Epub 2011 Dec 15.
PubMed 22174346Holas A, Krafft P, Marcovic M, Quehenberger F. Remifentanil, propofol or both for conscious sedation during eye surgery under regional anaesthesia. Eur J Anaesthesiol. 1999 Nov;16(11):741-8. doi: 10.1046/j.1365-2346.1999.00574.x.
PubMed 10713867Hsu YW, Cortinez LI, Robertson KM, Keifer JC, Sum-Ping ST, Moretti EW, Young CC, Wright DR, Macleod DB, Somma J. Dexmedetomidine pharmacodynamics: part I: crossover comparison of the respiratory effects of dexmedetomidine and remifentanil in healthy volunteers. Anesthesiology. 2004 Nov;101(5):1066-76. doi: 10.1097/00000542-200411000-00005.
PubMed 15505441Mohr M, Pillich D, Kirsch M, Mueller JU, Fleck S, Hosten N, Langner S. Percutaneous balloon kyphoplasty with the patient under intravenous analgesia and sedation: a feasibility study. AJNR Am J Neuroradiol. 2011 Apr;32(4):649-53. doi: 10.3174/ajnr.A2345. Epub 2011 Jan 27.
PubMed 21273350Della Puppa A, Andreula C, Frass M. Assisted sedation: a safe and easy method for pain-free percutaneous vertebroplasty. Minerva Anestesiol. 2008 Mar;74(3):57-62.
PubMed 18288067Lee JM, Lee SK, Lee SJ, Hwang WS, Jang SW, Park EY. Comparison of remifentanil with dexmedetomidine for monitored anaesthesia care in elderly patients during vertebroplasty and kyphoplasty. J Int Med Res. 2016 Apr;44(2):307-16. doi: 10.1177/0300060515607385. Epub 2016 Feb 18.
PubMed 26912506
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Remifentanil and Dexmedetomidine for Monitored Anaesthesia Care
- ClinicalTrials.gov ID
- NCT02476981
- Acronym / sponsor ID
- 2012-I039
- Conditions
- Fractures, Compression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 22 Jun 2015 (estimated)
- 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 randomised, double-blind study compared remifentanil and dexmedetomidine for monitored anaesthesia care (MAC) during minimally invasive corrections of vertebral compression fracture (vertebroplasty (VP) and kyphoplasty (KP)).
In total, 80 ASA physical status I-III patients scheduled for VP and KP randomly received remifentanil or dexmedetomidine to maintain OAA/S scale ≤ 4 during the procedures. Multiple hemodynamic variables of patients were recorded and the frequency of oxygen desaturation, respiratory depression, intraoperative need for other opioids, recovery time, operator satisfaction score, and patients' overall pain experiences were also compared.
The investigators are expecting that both remifentanil and dexmedetomidine appear to be quite safe for MAC during VP and KP. Thus, dexmedetomidine may be an alternative for MAC during VP and KP in elderly patients.
Detailed description
All patients fasted for 8 h before the procedure and were premedicated with midazolam 0.02 mg/kg. In the prone position, patients were monitored by ECG, non-invasive blood pressure, and pulse oximetry, and received supplemental oxygen (3 L/min) via a nasal cannula during the procedure.
Study drugs were prepared in 20 mL and 50 mL syringes to maintain a double-blind design. One anaesthesiologist administered normal saline or dexmedetomidine contained in the 20-mL syringe during the initial 10 min for loading dose of dexmedetomidine. Then, another investigator who did not know which syringes contained remifentanil or dexmedetomidine adjusted the infusion rate with a 50-mL syringe according to patients' response. After all patients in both groups received a bolus dose of propofol 0.3 mg/kg, patients given remifentanil received continuous infusion of the drug at 1-5 µg/kg/h, and patients receiving dexmedetomidine were given that drug at 0.3-0.4 µg/kg over 10 min, followed by continuous infusion of dexmedetomidine 0.2-1 µg/kg/h throughout the procedure. Levels of patient sedation were checked during the procedure and infusion rates of the study drugs were adjusted to maintain alertness/sedation below 4 on the OAA/S scale.
Mean arterial pressure (MAP), heart rate (HR), oxygen saturation (SpO2), respiratory rate (RR), and adverse effects of the study drugs were recorded during the procedure. Ephedrine 5 mg was injected when systolic blood pressure decreased below 90 mmHg. Duration of PACU stay was also recorded.
Operator satisfaction score and patient's overall pain experience were also recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Remifentanil | Experimental | Drug: RemifentanilRemifentanil is commonly used in monitored anesthesia care because of its rapid onset and short duration of action. |
| Dexmedetomidine | Experimental | Drug: DexmedetomidineDexmedetomidine is a highly selective α 2 adrenergic agonist and has both sedative and analgesic properties, and rarely causes respiratory depression. |
| midazolam | Other | Drug: Remifentanil, Drug: Dexmedetomidine, Drug: midazolamMidazolam is commonly used before induction for its anxiolytic effect. |
| propofol | Other | Drug: Remifentanil, Drug: Dexmedetomidine, Drug: propofolPropofol is the most commonly used in sedative analgesia for its rapid onset and recovery time. |
| ephedrine | Other | Drug: Remifentanil, Drug: Dexmedetomidine, Drug: ephedrineAdrenergic agonist to treat hypotension |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- patients who are scheduled for vertebroplasty or kyphoplasty under monitored anesthesia care
- ASA status I-III
- aged more than 65 years old.
Key exclusion criteria (8 listed)
- obesity (BMI > 30 kg/m2)
- hypotension (systolic blood pressure < 100 mmHg)
- bradycardia (heart rate < 60 bpm)
- heart block
- baseline oxygen desaturation (SpO2 < 90%)
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 |
|---|---|---|
| RemifentanilAlso: UltivaPatients given remifentanil received continuous infusion of the drug at 1-5 µg/kg/h | Drug | Remifentanil, ephedrine, midazolam, propofol |
| DexmedetomidineAlso: PrecedexPatients receiving dexmedetomidine were given that drug at 0.3-0.4 µg/kg over 10 min, followed by continuous infusion of 0.2 1 µg/kg/h | Drug | Dexmedetomidine, ephedrine, midazolam, propofol |
| midazolamAll patients were premedicated with midazolam 0.02 mg/kg before induction. | Drug | midazolam |
| propofolAlso: PofolAll patients in both groups received a bolus dose of propofol 0.3 mg/kg for sedative effect. | Drug | propofol |
| ephedrineEphedrine 5 mg was injected when systolic blood pressure decreased below 90 mmHg | Drug | ephedrine |
Primary outcome
The frequencies of oxygen desaturation during procedures
Time frame: About 1 hour through the procedures
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 24 Jun 2015.
- Background: PubMed 9599190Nevitt MC, Ettinger B, Black DM, Stone K, Jamal SA, Ensrud K, Segal M, Genant HK, Cummings SR. The association of radiographically detected vertebral fractures with back pain and function: a prospective study. Ann Intern Med. 1998 May 15;128(10):793-800. doi: 10.7326/0003-4819-128-10-199805150-00001.
- Background: PubMed 25886327Sen J, Sen B. A comparative study on monitored anesthesia care. Anesth Essays Res. 2014 Sep-Dec;8(3):313-8. doi: 10.4103/0259-1162.143121.
- Background: PubMed 22174346Ryu JH, Lee SW, Lee JH, Lee EH, Do SH, Kim CS. Randomized double-blind study of remifentanil and dexmedetomidine for flexible bronchoscopy. Br J Anaesth. 2012 Mar;108(3):503-11. doi: 10.1093/bja/aer400. Epub 2011 Dec 15.
- Background: PubMed 10713867Holas A, Krafft P, Marcovic M, Quehenberger F. Remifentanil, propofol or both for conscious sedation during eye surgery under regional anaesthesia. Eur J Anaesthesiol. 1999 Nov;16(11):741-8. doi: 10.1046/j.1365-2346.1999.00574.x.
- Background: PubMed 15505441Hsu YW, Cortinez LI, Robertson KM, Keifer JC, Sum-Ping ST, Moretti EW, Young CC, Wright DR, Macleod DB, Somma J. Dexmedetomidine pharmacodynamics: part I: crossover comparison of the respiratory effects of dexmedetomidine and remifentanil in healthy volunteers. Anesthesiology. 2004 Nov;101(5):1066-76. doi: 10.1097/00000542-200411000-00005.
- Background: PubMed 21273350Mohr M, Pillich D, Kirsch M, Mueller JU, Fleck S, Hosten N, Langner S. Percutaneous balloon kyphoplasty with the patient under intravenous analgesia and sedation: a feasibility study. AJNR Am J Neuroradiol. 2011 Apr;32(4):649-53. doi: 10.3174/ajnr.A2345. Epub 2011 Jan 27.
- Background: PubMed 18288067Della Puppa A, Andreula C, Frass M. Assisted sedation: a safe and easy method for pain-free percutaneous vertebroplasty. Minerva Anestesiol. 2008 Mar;74(3):57-62.
- Derived from this study: PubMed 26912506Lee JM, Lee SK, Lee SJ, Hwang WS, Jang SW, Park EY. Comparison of remifentanil with dexmedetomidine for monitored anaesthesia care in elderly patients during vertebroplasty and kyphoplasty. J Int Med Res. 2016 Apr;44(2):307-16. doi: 10.1177/0300060515607385. Epub 2016 Feb 18.
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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.
Eun Young Park, MD study chair
Hallym University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remifentanil, Dexmedetomidine and midazolam in people with Fractures, Compression, run by Hallym University Medical Center 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 24 Jun 2015. 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?
The frequencies of oxygen desaturation during procedures (time frame: About 1 hour through the procedures). 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 NCT02476981, which also lists 8 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 24 Jun 2015.