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

Taipei Veterans General Hospital

Status: Invitation-only

Conditions: Remimazolam; Propofol; Cardiac Electrophysiology; Hemodynamic

Treatments: Drug: Propofol; Device: With intubation and controlled ventilation to maintain airway; Drug: Remimazolam; Device: Maintain spontaneous ventilation without intubation

Study type: Interventional

Funder types: Other

Identifiers

NCT06700681

2024-06-005B

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 4 patient groups, including a placebo group

TIVA with Propofol and intubation

Placebo Comparator group

Description:

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

Treatment:

Device: With intubation and controlled ventilation to maintain airway

Drug: Propofol

TIVA with Remimazolam and intubation

Experimental group

Description:

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

Treatment:

Drug: Remimazolam

Device: With intubation and controlled ventilation to maintain airway

TIVA with Propofol and non-Intubated

Experimental group

Description:

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).

Treatment:

Device: Maintain spontaneous ventilation without intubation

Drug: Propofol

TIVA with Remimazolam and non-Intubated

Experimental group

Description:

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).

Treatment:

Device: Maintain spontaneous ventilation without intubation

Drug: Remimazolam