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

Primary Purpose

Fractures, Compression

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Remifentanil
Dexmedetomidine
midazolam
propofol
ephedrine
Sponsored by
Hallym University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fractures, Compression

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hallym University Sacred Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Other

Other

Other

Arm Label

Remifentanil

Dexmedetomidine

midazolam

propofol

ephedrine

Arm Description

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

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

Midazolam is commonly used before induction for its anxiolytic effect.

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

Adrenergic agonist to treat hypotension

Outcomes

Primary Outcome Measures

The frequencies of oxygen desaturation during procedures

Secondary Outcome Measures

Full Information

First Posted
June 16, 2015
Last Updated
June 22, 2015
Sponsor
Hallym University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02476981
Brief Title
Comparison of Remifentanil and Dexmedetomidine for Monitored Anaesthesia Care During Vertebroplasty and Kyphoplasty
Official Title
Comparison of Remifentanil and Dexmedetomidine for Monitored Anaesthesia Care
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hallym University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Compression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remifentanil
Arm Type
Experimental
Arm Description
Remifentanil is commonly used in monitored anesthesia care because of its rapid onset and short duration of action.
Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
Dexmedetomidine is a highly selective α 2 adrenergic agonist and has both sedative and analgesic properties, and rarely causes respiratory depression.
Arm Title
midazolam
Arm Type
Other
Arm Description
Midazolam is commonly used before induction for its anxiolytic effect.
Arm Title
propofol
Arm Type
Other
Arm Description
Propofol is the most commonly used in sedative analgesia for its rapid onset and recovery time.
Arm Title
ephedrine
Arm Type
Other
Arm Description
Adrenergic agonist to treat hypotension
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
Ultiva
Intervention Description
Patients given remifentanil received continuous infusion of the drug at 1-5 µg/kg/h
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
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
Intervention Name(s)
midazolam
Intervention Description
All patients were premedicated with midazolam 0.02 mg/kg before induction.
Intervention Type
Drug
Intervention Name(s)
propofol
Other Intervention Name(s)
Pofol
Intervention Description
All patients in both groups received a bolus dose of propofol 0.3 mg/kg for sedative effect.
Intervention Type
Drug
Intervention Name(s)
ephedrine
Intervention Description
Ephedrine 5 mg was injected when systolic blood pressure decreased below 90 mmHg
Primary Outcome Measure Information:
Title
The frequencies of oxygen desaturation during procedures
Time Frame
About 1 hour through the procedures

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eun Young Park, MD
Organizational Affiliation
Hallym University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang-si
State/Province
Dongan-gu
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
9599190
Citation
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Results Reference
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25886327
Citation
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Results Reference
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PubMed Identifier
22174346
Citation
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Results Reference
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PubMed Identifier
10713867
Citation
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Results Reference
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PubMed Identifier
15505441
Citation
Hsu 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.
Results Reference
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PubMed Identifier
21273350
Citation
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Results Reference
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Citation
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Citation
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Results Reference
derived

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

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