Impact of Two Different Types of Sedation on ICEB
Evaluation of the Effects of Two Different Sedation Protocols Used in Patients Undergoing Spinal Anesthesia on Cardiac Electrophysiology
1 other identifier
interventional
70
1 country
1
Brief Summary
The QT interval is a measure of the combination of cardiac depolarization and repolarization as it encompasses both the QRS complex and the J-T interval. QT, QTc, QTd prolongation or shortening has been associated with ventricular arrhythmias . In order to define non-torsogenic drug-induced arrhythmias, the index of cardio-electrophysiological balance (iCEB), which is a new marker calculated with the QT/QRS formula, has been defined. In our study, we planned to evaluate the effects of dexmedetomidine and propofol on cardiac electrophysiology with all these parameters, especially the newly defined iCEB.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2023
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedFirst Posted
Study publicly available on registry
March 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedDecember 18, 2023
December 1, 2023
4 months
February 22, 2023
December 12, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
ICEBc
QTc/QRS formula
İntraoperative 10th minute
Secondary Outcomes (10)
ICEB
Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
ICEBc
Baseline,İntraoperative 1th,5th,15th,30th,45th,75th minute
QT
Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
QTc
Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
QTd
Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
- +5 more secondary outcomes
Study Arms (2)
Propofol
ACTIVE COMPARATORSedation procedure with propofol
Dexmedetomidine
ACTIVE COMPARATORSedation procudure with dexmedetomidine
Interventions
After spinal anesthesia, patients will be sedated with dexmedetomidine.
Eligibility Criteria
You may qualify if:
- Patients with ASA Ⅰ-Ⅱ ,
- years old, who will be operated under spinal anesthesia
You may not qualify if:
- Hypersensitivity to the propofol,dexmedotimidine
- preoperative QTc prolongation
- preoperative heart disease
- use of drugs that affect the QT interval
- severe sinus bradycardia
- preoperative electrolyte abnormalities
- liver and kidney function abnormalities
- non-sinus rhythm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara City Hospital
Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
February 22, 2023
First Posted
March 7, 2023
Study Start
March 1, 2023
Primary Completion
July 1, 2023
Study Completion
August 1, 2023
Last Updated
December 18, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share