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

NCT02476981 | Completed

• 1 other identifier: 2012-I039
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Fractures, Compression

Outcome Measures

Primary Outcomes (1)

• The frequencies of oxygen desaturation during procedures

  About 1 hour through the procedures

Study Arms (5)

Remifentanil

EXPERIMENTAL

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

Drug: Remifentanil

Dexmedetomidine

EXPERIMENTAL

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

Drug: Dexmedetomidine

midazolam

OTHER

Midazolam is commonly used before induction for its anxiolytic effect.

Drug: Remifentanil; Drug: Dexmedetomidine; Drug: midazolam

propofol

OTHER

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

Drug: Remifentanil; Drug: Dexmedetomidine; Drug: propofol

ephedrine

OTHER

Adrenergic agonist to treat hypotension

Drug: Remifentanil; Drug: Dexmedetomidine; Drug: ephedrine

Interventions

Remifentanil DRUG

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

Also known as: Ultiva

Remifentanil; ephedrine; midazolam; propofol

Dexmedetomidine 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

Also known as: Precedex

Dexmedetomidine; ephedrine; midazolam; propofol

midazolam DRUG

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

midazolam

propofol DRUG

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

Also known as: Pofol

propofol

ephedrine DRUG

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

ephedrine

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• patients who are scheduled for vertebroplasty or kyphoplasty under monitored anesthesia care
• ASA status I-III
• aged more than 65 years old.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hallym University Medical Center: lead

Study Sites (1)

Hallym University Sacred Heart Hospital

Anyang-si, Dongan-gu, South Korea

Location

Related Publications (8)

• 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.

  PMID: 9599190 BACKGROUND

• 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.

  PMID: 25886327 BACKGROUND

• 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.

  PMID: 22174346 BACKGROUND

• 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.

  PMID: 10713867 BACKGROUND

• 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.

  PMID: 15505441 BACKGROUND

• 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.

  PMID: 21273350 BACKGROUND

• 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.

  PMID: 18288067 BACKGROUND

• 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.

  PMID: 26912506 DERIVED

MeSH Terms

Conditions

Fractures, Compression

Interventions

Remifentanil; Dexmedetomidine; Midazolam; Propofol; Ephedrine

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Phenethylamines; Ethylamines

Study Officials

• Eun Young Park, MD

  Hallym University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 22, 2015
• Study Start: August 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: October 1, 2014
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

KR (1)