- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02476981
Comparison of Remifentanil and Dexmedetomidine for Monitored Anaesthesia Care During Vertebroplasty and Kyphoplasty
Comparison of Remifentanil and Dexmedetomidine for Monitored Anaesthesia Care
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Dongan-gu
-
Anyang-si, Dongan-gu, Korea, Republic of
- Hallym University Sacred Heart Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Remifentanil
Remifentanil is commonly used in monitored anesthesia care because of its rapid onset and short duration of action.
|
Patients given remifentanil received continuous infusion of the drug at 1-5 µg/kg/h
Other Names:
|
EXPERIMENTAL: Dexmedetomidine
Dexmedetomidine is a highly selective α 2 adrenergic agonist and has both sedative and analgesic properties, and rarely causes respiratory depression.
|
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 Names:
|
OTHER: midazolam
Midazolam is commonly used before induction for its anxiolytic effect.
|
Patients given remifentanil received continuous infusion of the drug at 1-5 µg/kg/h
Other Names:
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 Names:
All patients were premedicated with midazolam 0.02 mg/kg before induction.
|
OTHER: propofol
Propofol is the most commonly used in sedative analgesia for its rapid onset and recovery time.
|
Patients given remifentanil received continuous infusion of the drug at 1-5 µg/kg/h
Other Names:
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 Names:
All patients in both groups received a bolus dose of propofol 0.3 mg/kg for sedative effect.
Other Names:
|
OTHER: ephedrine
Adrenergic agonist to treat hypotension
|
Patients given remifentanil received continuous infusion of the drug at 1-5 µg/kg/h
Other Names:
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 Names:
Ephedrine 5 mg was injected when systolic blood pressure decreased below 90 mmHg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The frequencies of oxygen desaturation during procedures
Time Frame: About 1 hour through the procedures
|
About 1 hour through the procedures
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Eun Young Park, MD, Hallym University Medical Center
Publications and helpful links
General Publications
- Nevitt MC, Ettinger B, Black DM, Stone K, Jamal SA, Ensrud K, Segal M, Genant HK, Cummings SR. The association of radiographically detected vertebral fractures with back pain and function: a prospective study. Ann Intern Med. 1998 May 15;128(10):793-800. doi: 10.7326/0003-4819-128-10-199805150-00001.
- Sen J, Sen B. A comparative study on monitored anesthesia care. Anesth Essays Res. 2014 Sep-Dec;8(3):313-8. doi: 10.4103/0259-1162.143121.
- Ryu JH, Lee SW, Lee JH, Lee EH, Do SH, Kim CS. Randomized double-blind study of remifentanil and dexmedetomidine for flexible bronchoscopy. Br J Anaesth. 2012 Mar;108(3):503-11. doi: 10.1093/bja/aer400. Epub 2011 Dec 15.
- Holas A, Krafft P, Marcovic M, Quehenberger F. Remifentanil, propofol or both for conscious sedation during eye surgery under regional anaesthesia. Eur J Anaesthesiol. 1999 Nov;16(11):741-8. doi: 10.1046/j.1365-2346.1999.00574.x.
- 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.
- Mohr M, Pillich D, Kirsch M, Mueller JU, Fleck S, Hosten N, Langner S. Percutaneous balloon kyphoplasty with the patient under intravenous analgesia and sedation: a feasibility study. AJNR Am J Neuroradiol. 2011 Apr;32(4):649-53. doi: 10.3174/ajnr.A2345. Epub 2011 Jan 27.
- Della Puppa A, Andreula C, Frass M. Assisted sedation: a safe and easy method for pain-free percutaneous vertebroplasty. Minerva Anestesiol. 2008 Mar;74(3):57-62.
- Lee JM, Lee SK, Lee SJ, Hwang WS, Jang SW, Park EY. Comparison of remifentanil with dexmedetomidine for monitored anaesthesia care in elderly patients during vertebroplasty and kyphoplasty. J Int Med Res. 2016 Apr;44(2):307-16. doi: 10.1177/0300060515607385. Epub 2016 Feb 18.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Fractures, Bone
- Wounds and Injuries
- Fractures, Compression
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Analgesics, Opioid
- Narcotics
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Central Nervous System Stimulants
- Sympathomimetics
- Vasoconstrictor Agents
- Remifentanil
- Midazolam
- Propofol
- Dexmedetomidine
- Ephedrine
Other Study ID Numbers
- 2012-I039
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