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

NCT06700681 | Enrolling By Invitation DMC

• 1 other identifier: 2024-06-005B
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamic; Remimazolam; Propofol; Cardiac Electrophysiology

Outcome Measures

Primary Outcomes (1)

• Hemodynamic stability--Vasopressor dosage

  Total dosage of vasopressor used during the procedure

  Introperative

Secondary Outcomes (10)

• Respiratory depression require intubation

  Introperative

• TIVA failure rate

  Introperative

• LOC time

  Introperative

• Emergence time

  Introperative

• Sanctification of cardiologist

  Perioperative

Study Arms (4)

TIVA with Propofol and intubation

PLACEBO COMPARATOR

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; Device: With intubation and controlled ventilation to maintain airway

TIVA with Remimazolam and intubation

EXPERIMENTAL

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

Drug: Remimazolam; Device: With intubation and controlled ventilation to maintain airway

TIVA with Propofol and non-Intubated

EXPERIMENTAL

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; Device: Maintain spontaneous ventilation without intubation

TIVA with Remimazolam and non-Intubated

EXPERIMENTAL

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; Device: Maintain spontaneous ventilation without intubation

Interventions

Propofol DRUG

TIVA induction and maintain with Propofol.

TIVA with Propofol and intubation; TIVA with Propofol and non-Intubated

Remimazolam DRUG

TIVA induction and maintain with Remimazolam.

TIVA with Remimazolam and intubation; TIVA with Remimazolam and non-Intubated

With intubation and controlled ventilation to maintain airway DEVICE

Patient receives intubation and controlled ventilation to maintain airway.

TIVA with Propofol and intubation; TIVA with Remimazolam and intubation

Maintain spontaneous ventilation without intubation DEVICE

Patient maintains spontaneous ventilation without intubation.

TIVA with Propofol and non-Intubated; TIVA with Remimazolam and non-Intubated

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Interventions

Propofol; remimazolam; Intubation

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Therapeutics; Investigative Techniques

Study Officials

• Li Yi-Shiuan, Bachelor's

  Taipei Veterans General Hospital, Taiwan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: November 22, 2024
• Study Start: September 20, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)