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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06700681
Enrollment
200
Registered
2024-11-22
Start date
2024-09-20
Completion date
2026-12-31
Last updated
2024-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Electrophysiology, Hemodynamic, Propofol, Remimazolam

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.

Interventions

DRUGPropofol

TIVA induction and maintain with Propofol.

DRUGRemimazolam

TIVA induction and maintain with Remimazolam.

DEVICEWith intubation and controlled ventilation to maintain airway

Patient receives intubation and controlled ventilation to maintain airway.

DEVICEMaintain spontaneous ventilation without intubation

Patient maintains spontaneous ventilation without intubation.

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hemodynamic stability--Vasopressor dosageIntroperativeTotal dosage of vasopressor used during the procedure

Secondary

MeasureTime frameDescription
TIVA failure rateIntroperativeThe incidence of TIVA shift to inhalation anesthetics
LOC timeIntroperativeTime from start induction to loss of conscious
Emergence timeIntroperativeTime from stop intravenous anesthetics infusion to eye opening
Sanctification of cardiologistPerioperativeThe sanctification score of the cardiologist
Respiratory depression require intubationIntroperativeThe incidence of patients in non-intubated groups receive intubation
Mini-CogPreoperative to post-operative day 1The result of Mini-Cog score
Length of hospital stayUpto 1 monthLength of hospital stay
Adverse outcomeUpto 1 monthAny adverse outcome
Length of CU stayUpto 1 monthLength of CU stay
QoR-15Preoperative to post-operative day 1The result of QoR-15 score

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026