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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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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

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Fractures, Compression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Remifentanil

Remifentanil is commonly used in monitored anesthesia care because of its rapid onset and short duration of action.

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

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

Dexmedetomidine

Dexmedetomidine is a highly selective α 2 adrenergic agonist and has both sedative and analgesic properties, and rarely causes respiratory depression.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

midazolam

Midazolam is commonly used before induction for its anxiolytic effect.

Group Type OTHER

Remifentanil

Intervention Type DRUG

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

Dexmedetomidine

Intervention Type DRUG

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

midazolam

Intervention Type DRUG

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

propofol

Propofol is the most commonly used in sedative analgesia for its rapid onset and recovery time.

Group Type OTHER

Remifentanil

Intervention Type DRUG

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

Dexmedetomidine

Intervention Type DRUG

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

propofol

Intervention Type DRUG

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

ephedrine

Adrenergic agonist to treat hypotension

Group Type OTHER

Remifentanil

Intervention Type DRUG

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

Dexmedetomidine

Intervention Type DRUG

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

ephedrine

Intervention Type DRUG

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

Interventions

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Remifentanil

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

Intervention Type DRUG

Dexmedetomidine

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

Intervention Type DRUG

midazolam

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

Intervention Type DRUG

propofol

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

Intervention Type DRUG

ephedrine

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

Intervention Type DRUG

Other Intervention Names

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Ultiva Precedex Pofol

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No