An interventional study of Remifentanil and Dexmedetomidine in Fractures, Compression, sponsored by Hallym University Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2015-06-24.
Sponsored by Hallym University Medical Center · Not applicable, Interventional, and Treatment
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.
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.
50 studies on the registry are indexed under Fractures, Compression; 10 are open to participants now.
This study's enrollment of 75 is close to the median of 73 across 32 interventional studies indexed under Fractures, Compression.
Browse Fractures, Compression studies →Hallym University Medical Center is the lead sponsor of 53 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Remifentanil is commonly used in monitored anesthesia care because of its rapid onset and short duration of action.
Drug: Remifentanil
Dexmedetomidine is a highly selective α 2 adrenergic agonist and has both sedative and analgesic properties, and rarely causes respiratory depression.
Drug: Dexmedetomidine
Midazolam is commonly used before induction for its anxiolytic effect.
Drug: Remifentanil · Drug: Dexmedetomidine · Drug: midazolam
Propofol is the most commonly used in sedative analgesia for its rapid onset and recovery time.
Drug: Remifentanil · Drug: Dexmedetomidine · Drug: propofol
Adrenergic agonist to treat hypotension
Drug: Remifentanil · Drug: Dexmedetomidine · Drug: ephedrine
Patients given remifentanil received continuous infusion of the drug at 1-5 µg/kg/h
Also known as: Ultiva
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
Also known as: Precedex
All patients were premedicated with midazolam 0.02 mg/kg before induction.
All patients in both groups received a bolus dose of propofol 0.3 mg/kg for sedative effect.
Also known as: Pofol
Ephedrine 5 mg was injected when systolic blood pressure decreased below 90 mmHg
The frequencies of oxygen desaturation during procedures
Time frame: About 1 hour through the procedures
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Remifentanil · Dexmedetomidine
Hallym University Medical Center