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Comparison of Remifentanil and Dexmedetomidine for Monitored Anaesthesia Care During Vertebroplasty and Kyphoplasty

Comparison of Remifentanil and Dexmedetomidine for Monitored Anaesthesia Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02476981
Enrollment
75
Registered
2015-06-22
Start date
2012-08-31
Completion date
2014-10-31
Last updated
2015-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fractures, Compression

Brief 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)). 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.

Interventions

DRUGRemifentanil

Patients given remifentanil received continuous infusion of the drug at 1-5 µg/kg/h

DRUGDexmedetomidine

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

DRUGmidazolam

All patients were premedicated with midazolam 0.02 mg/kg before induction.

DRUGpropofol

All patients in both groups received a bolus dose of propofol 0.3 mg/kg for sedative effect.

DRUGephedrine

Ephedrine 5 mg was injected when systolic blood pressure decreased below 90 mmHg

Sponsors

Hallym University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients who are scheduled for vertebroplasty or kyphoplasty under monitored anesthesia care * ASA status I-III * aged more than 65 years old.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
The frequencies of oxygen desaturation during proceduresAbout 1 hour through the procedures

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026