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

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ClinicalTrials.gov Identifier: NCT02476981
Recruitment Status : Completed
First Posted : June 22, 2015
Last Update Posted : June 24, 2015
Sponsor:
Information provided by (Responsible Party):
Hallym University Medical Center

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.


Condition or disease Intervention/treatment Phase
Fractures, Compression Drug: Remifentanil Drug: Dexmedetomidine Drug: midazolam Drug: propofol Drug: ephedrine Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Remifentanil and Dexmedetomidine for Monitored Anaesthesia Care
Study Start Date : August 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Remifentanil
Remifentanil is commonly used in monitored anesthesia care because of its rapid onset and short duration of action.
Drug: Remifentanil
Patients given remifentanil received continuous infusion of the drug at 1-5 µg/kg/h
Other Name: Ultiva

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

midazolam
Midazolam is commonly used before induction for its anxiolytic effect.
Drug: Remifentanil
Patients given remifentanil received continuous infusion of the drug at 1-5 µg/kg/h
Other Name: Ultiva

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
Other Name: Precedex

Drug: midazolam
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.
Drug: Remifentanil
Patients given remifentanil received continuous infusion of the drug at 1-5 µg/kg/h
Other Name: Ultiva

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
Other Name: Precedex

Drug: propofol
All patients in both groups received a bolus dose of propofol 0.3 mg/kg for sedative effect.
Other Name: Pofol

ephedrine
Adrenergic agonist to treat hypotension
Drug: Remifentanil
Patients given remifentanil received continuous infusion of the drug at 1-5 µg/kg/h
Other Name: Ultiva

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
Other Name: Precedex

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




Primary Outcome Measures :
  1. The frequencies of oxygen desaturation during procedures [ Time Frame: About 1 hour through the procedures ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476981


Locations
Korea, Republic of
Hallym University Sacred Heart Hospital
Anyang-si, Dongan-gu, Korea, Republic of
Sponsors and Collaborators
Hallym University Medical Center
Investigators
Study Chair: Eun Young Park, MD Hallym University Medical Center

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT02476981     History of Changes
Other Study ID Numbers: 2012-I039
First Posted: June 22, 2015    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Fractures, Compression
Fractures, Bone
Wounds and Injuries
Anesthetics
Propofol
Midazolam
Remifentanil
Dexmedetomidine
Ephedrine
Adrenergic Agonists
Pseudoephedrine
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators