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Sedation Regimen in Patients Undergoing Cardiac Electrophysiology Study and Ablation : a Comparison Between Dexmedetomidine-remifentanil and Midazolam-remifentanil Combinations

NCT ID: NCT01652586

Last Updated: 2012-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Arrhythmia

Keywords

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cardiac ablation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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dexmedetomidine-remifentanil

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

Group Type EXPERIMENTAL

dexmedetomidine-remifentanil

Intervention Type DRUG

midazolam-remifentanil

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

Group Type ACTIVE_COMPARATOR

midazolam-remifentanil

Intervention Type DRUG

Interventions

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dexmedetomidine-remifentanil

Intervention Type DRUG

midazolam-remifentanil

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients scheduled for elective cardiac ablation for atrial fibrillation

Exclusion Criteria

* ASA physical status class ≥ 3,
* respiratory disease,
* end stage renal disease,
* illiterate
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Young Lan Kwak, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Other Identifiers

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1-2011-0008

Identifier Type: -

Identifier Source: org_study_id