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NCT Number: NCT06700681

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

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.

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Key information

Conditions

Hemodynamic Cardiac Electrophysiology Propofol Remimazolam

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Veterans General Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

TIVA induction and maintain with Propofol.

Remimazolam

Drug

TIVA induction and maintain with Remimazolam.

With intubation and controlled ventilation to maintain airway

Device

Patient receives intubation and controlled ventilation to maintain airway.

Maintain spontaneous ventilation without intubation

Device

Patient maintains spontaneous ventilation without intubation.

Primary outcomes

  1. Hemodynamic stability--Vasopressor dosage

    Time frame: Introperative

    Total dosage of vasopressor used during the procedure

Secondary outcomes

  1. Respiratory depression require intubation

    Time frame: Introperative

    The incidence of patients in non-intubated groups receive intubation

  2. TIVA failure rate

    Time frame: Introperative

    The incidence of TIVA shift to inhalation anesthetics

  3. LOC time

    Time frame: Introperative

    Time from start induction to loss of conscious

  4. Emergence time

    Time frame: Introperative

    Time from stop intravenous anesthetics infusion to eye opening

  5. Sanctification of cardiologist

    Time frame: Perioperative

    The sanctification score of the cardiologist

  6. QoR-15

    Time frame: Preoperative to post-operative day 1

    The result of QoR-15 score

  7. Mini-Cog

    Time frame: Preoperative to post-operative day 1

    The result of Mini-Cog score

  8. Length of hospital stay

    Time frame: Upto 1 month

    Length of hospital stay

  9. Adverse outcome

    Time frame: Upto 1 month

    Any adverse outcome

  10. Length of CU stay

    Time frame: Upto 1 month

    Length of CU stay

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 22, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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