RCT Comparing Remimazolam With Propofol Under EEG DSA Guidance During Cardiac Electrophysiology Studies and Ablation

NCT ID: NCT06700681

Last Updated: 2024-11-22

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

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-20

Study Completion Date

2026-12-31

Brief Summary

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Brief Summary:

The goal of this RCT is to compare the Safety and efficacy of remimazolam compared with propofol under EEG DSA guiding during cardiac electrophysiology studies and ablation. The main questions it aims to answer are:

* Is Remimazolam as efficacy as propofol in cardiac electrophysiology studies and ablation?
* Is Remimazolam lower hypotension episodes or lower vasopressor dosages compare with propofol in cardiac electrophysiology studies and ablation? If there is a comparison group: Researchers will compare \[arm information\] to see if \[insert effects\].

Researchers will compare Remimazolam to Propofol to see if Remimazolam is more feasible in cardiac electrophysiology studies and ablation.

Participants will receive either Remimazolam or Propofol sedation during study period.

Detailed Description

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Conditions

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Hemodynamic Remimazolam Propofol Cardiac Electrophysiology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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TIVA with Propofol and intubation

Patient received cardiac electrophysiology studies and ablation under TIVA with Propofol induction and maintenance and airway is maintained with intubation and controlled ventilation.

Group Type PLACEBO_COMPARATOR

Propofol

Intervention Type DRUG

TIVA induction and maintain with Propofol.

With intubation and controlled ventilation to maintain airway

Intervention Type DEVICE

Patient receives intubation and controlled ventilation to maintain airway.

TIVA with Remimazolam and intubation

Patient received cardiac electrophysiology studies and ablation under TIVA with Remimazolam induction and maintenance and airway is maintained with intubation and controlled ventilation.

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

TIVA induction and maintain with Remimazolam.

With intubation and controlled ventilation to maintain airway

Intervention Type DEVICE

Patient receives intubation and controlled ventilation to maintain airway.

TIVA with Propofol and non-Intubated

Patient received cardiac electrophysiology studies and ablation under TIVA with Propofol induction and maintenance and airway is maintained with spontaneous ventilation without intubation(non-intubated).

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

TIVA induction and maintain with Propofol.

Maintain spontaneous ventilation without intubation

Intervention Type DEVICE

Patient maintains spontaneous ventilation without intubation.

TIVA with Remimazolam and non-Intubated

Patient received cardiac electrophysiology studies and ablation under TIVA with Remimazolam induction and maintenance and airway is maintained with spontaneous ventilation without intubation(non-intubated).

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

TIVA induction and maintain with Remimazolam.

Maintain spontaneous ventilation without intubation

Intervention Type DEVICE

Patient maintains spontaneous ventilation without intubation.

Interventions

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Propofol

TIVA induction and maintain with Propofol.

Intervention Type DRUG

Remimazolam

TIVA induction and maintain with Remimazolam.

Intervention Type DRUG

With intubation and controlled ventilation to maintain airway

Patient receives intubation and controlled ventilation to maintain airway.

Intervention Type DEVICE

Maintain spontaneous ventilation without intubation

Patient maintains spontaneous ventilation without intubation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient receives scheduled cardiac electrophysiology studies and ablation by the same cardiologist(one of the study investigator).

Exclusion Criteria

* With existing vasopressor or shock status
* Patient refusal or cannot finish Mini-Cog or QoR-15 preoperatively
* Canceled by cardiologist
* Allergy history to the anesthetics used in this study
* History of abnormal lung function or required oxygen therapy preoperative
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li Yi-Shiuan, Bachelor's

Role: STUDY_DIRECTOR

Taipei Veterans General Hospital, Taiwan

Locations

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Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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2024-06-005B

Identifier Type: -

Identifier Source: org_study_id

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