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

June 22, 2015 updated by: Hallym University Medical Center

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

Completed

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

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Dongan-gu
      • Anyang-si, Dongan-gu, Korea, Republic of
        • Hallym University Sacred Heart Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Drug: Remifentanil
Patients given remifentanil received continuous infusion of the drug at 1-5 µg/kg/h
Other Names:
  • 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 Names:
  • Precedex
OTHER: 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 Names:
  • 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 Names:
  • Precedex
Drug: midazolam
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.
Drug: Remifentanil
Patients given remifentanil received continuous infusion of the drug at 1-5 µg/kg/h
Other Names:
  • 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 Names:
  • Precedex
Drug: propofol
All patients in both groups received a bolus dose of propofol 0.3 mg/kg for sedative effect.
Other Names:
  • Pofol
OTHER: ephedrine
Adrenergic agonist to treat hypotension
Drug: Remifentanil
Patients given remifentanil received continuous infusion of the drug at 1-5 µg/kg/h
Other Names:
  • 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 Names:
  • Precedex
Drug: ephedrine
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

This is where you will find people and organizations involved with this study.

Sponsor

Hallym University Medical Center

Investigators

  • Study Chair: Eun Young Park, MD, Hallym University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

June 16, 2015

First Submitted That Met QC Criteria

June 19, 2015

First Posted (ESTIMATE)

June 22, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2015

Last Update Submitted That Met QC Criteria

June 22, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-I039

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fractures, Compression

Clinical Trials on Remifentanil

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe