NCT01652586

Brief Summary

Cardiac ablation is an invasive procedure requiring anesthetic support for immobility and analgesia. Benzodiazepines and opioids are the most commonly used agents, while they are associated with respiratory depression and hypotension. The aim of this study was to compare the effect of remifentanil and dexmedetomidine, which exerts sedative and analgesic effect without serious respiratory depression, with conventional midazolam/remifentanil combination on sedative and analgesic levels in patients undergoing endocardial ablation.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2012

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

8 months

First QC Date

July 23, 2012

Last Update Submit

July 27, 2012

Conditions

Cardiac Arrhythmia

Keywords

cardiac ablation

Outcome Measures

Primary Outcomes (1)

  • change of sedation depth

    1. Ramsay sedation score (1 = anxious and agitated, restless; 2 = cooperative, oriented, tranquil; 3 = responsive to verbal commands, drowsy; 4 = asleep, responsive to light stimulation; 5 = asleep, slow response to stimulation; 6 = no response to stimulation) 2. the bispectral index

    5 min after study drug adminstration, and every 10 min thereafter

Study Arms (2)

dexmedetomidine-remifentanil

EXPERIMENTAL

intravenous infusion of 0.2-0.7 µg/kg/h of dexmedetomidine after a loading dose of 1 µg/kg over 10 min

Drug: dexmedetomidine-remifentanil

midazolam-remifentanil

ACTIVE COMPARATOR

remifentanil 3.6-7.2 mcg/kg/h midazolam 1-2mg

Drug: midazolam-remifentanil

Interventions

dexmedetomidine-remifentanilDRUG
dexmedetomidine-remifentanil
midazolam-remifentanilDRUG
midazolam-remifentanil

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients scheduled for elective cardiac ablation for atrial fibrillation

You may not qualify if:

  • ASA physical status class ≥ 3,
  • respiratory disease,
  • end stage renal disease,
  • illiterate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Young Lan Kwak, MD, PhD

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 23, 2012

First Posted

July 30, 2012

Study Start

April 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

July 30, 2012

Record last verified: 2012-07