CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 75 enrolled
Drug / intervention
Remifentanil +4 moredrug
Likely dose
Remifentanil 5 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02476981
NCT02476981N/ACompleted

Comparison of Remifentanil and Dexmedetomidine for Monitored Anaesthesia Care

Hallym University Medical Center·interventional·Posted Jun 22, 2015·Updated Jun 24, 2015

In Brief

A clinical study evaluating Remifentanil, Dexmedetomidine, and 3 other interventions for Fractures, Compression. Completed, enrolled 75 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 22, 2015
Enrollment StartAug 1, 2012
Primary CompletionJul 1, 2014
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.0 years ago

Interventions

Remifentanildrug

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

Dexmedetomidinedrug

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

midazolamdrug

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

propofoldrug

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

ephedrinedrug

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