NCT02515188

Brief Summary

Sedation for catheter ablation of atrial fibrillation should be performed to achieve analgesia, immobilization, and maintenance of airway. Various anesthetic agents such as propofol, dexmedetomidine, and midazolam were investigated to achieve this goal. However, propofol and midazolam causes respiratory depression and dexmedetomidine occasionally accompanies hypotension or hypertension and bradycardia. Therefore, anesthetic agent that does not induce respiratory depression with stable hemodynamics is needed. Propacetamol (Denogan®, Yungjin, Seoul, Korea) is injectable prodrug of acetaminophen and 1st line drug for fever and pain. In a previous study, paracetamol reduced morphine consumption after surgery. And paracetamol does not cause respiratory depression. Thus, the investigators hypothesized that addition of propacetamol to previously used sedatives midazolam-remifentanil will reduce opioid consumption during the catheter ablation. Therefore, the investigators designed this study to investigate the role of addition of propacetamol to previous used midazolam-remifentanil sedation. This study will compare the opioid consumption and respiratory effect of propacetamol with placebo-control for catheter ablation of atrial fibrillation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

August 7, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2016

Completed
Last Updated

January 28, 2019

Status Verified

January 1, 2019

Enrollment Period

11 months

First QC Date

July 30, 2015

Last Update Submit

January 24, 2019

Conditions

Arrhythmia

Outcome Measures

Primary Outcomes (1)

  • total amount of opioid consumption

    Total opioid consumption during the procedure will be recorded. And post procedural consumption of analgesics also will be recorded.

    1 day

Secondary Outcomes (9)

  • Respiratory rate

    1 day

  • Depth of sedation

    1 day

  • Post procedural pain

    1 day

  • nausea point

    1 day

  • number of vomiting

    1 day

  • +4 more secondary outcomes

Study Arms (2)

propacetamol group

EXPERIMENTAL
Drug: Propacetamol

placebo group

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PropacetamolDRUG

Randomly selected patients of the propacetamol group are given intravenous propacetamol 2g for 15 minutes on the beginning of the procedure.

Also known as: Propacetamol (Denogan®, Yungjin, Seoul, Korea)
propacetamol group
PlaceboDRUG

Placebo group are given intravenous Normal Saline 2g for 15 minutes on the beginning of the procedure.

Also known as: Normal Saline
placebo group

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who are scheduled to undergo catheter ablation for arrhythmia

You may not qualify if:

  • Subjects are ineligible if they have liver disease, kidney disease,
  • American society of anesthesiology class 3 or 4,
  • age under 20 years,
  • cognitive dysfunction,
  • disabling mental change disorder,
  • patients are unable to communicate or speak Korean

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

propacetamolSaline Solution

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

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

Study Record Dates

First Submitted

July 30, 2015

First Posted

August 4, 2015

Study Start

August 7, 2015

Primary Completion

June 23, 2016

Study Completion

June 23, 2016

Last Updated

January 28, 2019

Record last verified: 2019-01

Locations

KR(1)