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

Fractures, Compression Clinical Trial

Official title:

Comparison of Remifentanil and Dexmedetomidine for Monitored Anaesthesia Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02476981
• Other study ID #: 2012-I039
• Status: Completed
• Phase: N/A
• First received: June 16, 2015
• Last updated: June 22, 2015
• Start date: August 2012
• Est. completion date: October 2014

Study information

• Verified date: June 2015
• Source: Hallym University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Compression

Intervention

Drug:
• Remifentanil
Patients given remifentanil received continuous infusion of the drug at 1-5 µg/kg/h
• 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
• midazolam
All patients were premedicated with midazolam 0.02 mg/kg before induction.
• propofol
All patients in both groups received a bolus dose of propofol 0.3 mg/kg for sedative effect.
• ephedrine
Ephedrine 5 mg was injected when systolic blood pressure decreased below 90 mmHg

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang-si	Dongan-gu

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequencies of oxygen desaturation during procedures		About 1 hour through the procedures	No