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

Not Applicable

• Conditions: Hemodynamic; Remimazolam; Propofol; Cardiac Electrophysiology
• Interventions: Drug: Propofol; Drug: Remimazolam; Device: With intubation and controlled ventilation to maintain airway; Device: Maintain spontaneous ventilation without intubation

• Registration Number: NCT06700681
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2024-09-10
• Study Start: 2024-09-20
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TIVA with Propofol and intubation	Propofol	Patient received cardiac electrophysiology studies and ablation under TIVA with Propofol induction and maintenance and airway is maintained with intubation and controlled ventilation.
TIVA with Propofol and intubation	With intubation and controlled ventilation to maintain airway	Patient received cardiac electrophysiology studies and ablation under TIVA with Propofol induction and maintenance and airway is maintained with intubation and controlled ventilation.
TIVA with Remimazolam and intubation	Remimazolam	Patient received cardiac electrophysiology studies and ablation under TIVA with Remimazolam induction and maintenance and airway is maintained with intubation and controlled ventilation.
TIVA with Remimazolam and intubation	With intubation and controlled ventilation to maintain airway	Patient received cardiac electrophysiology studies and ablation under TIVA with Remimazolam induction and maintenance and airway is maintained with intubation and controlled ventilation.
TIVA with Propofol and non-Intubated	Propofol	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).
TIVA with Propofol and non-Intubated	Maintain spontaneous ventilation without intubation	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).
TIVA with Remimazolam and non-Intubated	Remimazolam	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).
TIVA with Remimazolam and non-Intubated	Maintain spontaneous ventilation without intubation	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).

Primary Outcome Measures

Name	Time	Method
Hemodynamic stability--Vasopressor dosage	Introperative	Total dosage of vasopressor used during the procedure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan