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

November 19, 2024 updated by: Taipei Veterans General Hospital, Taiwan

Safety and Efficacy of Remimazolam Compared With Propofol Under EEG DSA Guiding During Cardiac Electrophysiology Studies and Ablation: Randomized Controlled Trial

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Drug: Propofol
TIVA induction and maintain with Propofol.
Device: With intubation and controlled ventilation to maintain airway
Patient receives intubation and controlled ventilation to maintain airway.
Experimental: 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.
Device: With intubation and controlled ventilation to maintain airway
Patient receives intubation and controlled ventilation to maintain airway.
Drug: Remimazolam
TIVA induction and maintain with Remimazolam.
Experimental: 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).
Drug: Propofol
TIVA induction and maintain with Propofol.
Device: Maintain spontaneous ventilation without intubation
Patient maintains spontaneous ventilation without intubation.
Experimental: 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).
Drug: Remimazolam
TIVA induction and maintain with Remimazolam.
Device: Maintain spontaneous ventilation without intubation
Patient maintains spontaneous ventilation without intubation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodynamic stability--Vasopressor dosage
Time Frame: Introperative
Total dosage of vasopressor used during the procedure
Introperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory depression require intubation
Time Frame: Introperative
The incidence of patients in non-intubated groups receive intubation
Introperative
TIVA failure rate
Time Frame: Introperative
The incidence of TIVA shift to inhalation anesthetics
Introperative
LOC time
Time Frame: Introperative
Time from start induction to loss of conscious
Introperative
Emergence time
Time Frame: Introperative
Time from stop intravenous anesthetics infusion to eye opening
Introperative
Sanctification of cardiologist
Time Frame: Perioperative
The sanctification score of the cardiologist
Perioperative
QoR-15
Time Frame: Preoperative to post-operative day 1
The result of QoR-15 score
Preoperative to post-operative day 1
Mini-Cog
Time Frame: Preoperative to post-operative day 1
The result of Mini-Cog score
Preoperative to post-operative day 1
Length of hospital stay
Time Frame: Upto 1 month
Length of hospital stay
Upto 1 month
Adverse outcome
Time Frame: Upto 1 month
Any adverse outcome
Upto 1 month
Length of CU stay
Time Frame: Upto 1 month
Length of CU stay
Upto 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Investigators

  • Study Director: Li Yi-Shiuan, Bachelor's, Taipei Veterans General Hospital, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 10, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Estimated)

November 22, 2024

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-06-005B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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