Knee Osteoarthritis Clinical Trial
Official title:
Evaluation of the Effects of Two Different Sedation Protocols Used in Patients Undergoing Spinal Anesthesia on Cardiac Electrophysiology
NCT number | NCT05757063 |
Other study ID # | ICEB |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2023 |
Est. completion date | August 1, 2023 |
Verified date | December 2023 |
Source | Ankara City Hospital Bilkent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | August 1, 2023 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Patients with ASA ?-? , - 18-80 years old, who will be operated under spinal anesthesia Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara City Hospital | Ankara |
Lead Sponsor | Collaborator |
---|---|
Ankara City Hospital Bilkent |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ICEBc | QTc/QRS formula | Intraoperative 10th minute | |
Secondary | ICEB | Index of cardio-electrophysiological balance (iCEB); calculated as QT distance divided by QRS duration (QT/ QRS), it will be calculated from the ECG. | Baseline,Intraoperative 1th,5th,10th,15th,30th,45th,75th minute | |
Secondary | ICEBc | QTc/QRS formula | Baseline,Intraoperative 1th,5th,15th,30th,45th,75th minute | |
Secondary | QT | The investigator will assess the QT interval | Baseline,Intraoperative 1th,5th,10th,15th,30th,45th,75th minute | |
Secondary | QTc | The investigator will assess the QTc interval | Baseline,Intraoperative 1th,5th,10th,15th,30th,45th,75th minute | |
Secondary | QTd | maxQT-minQT | Baseline,Intraoperative 1th,5th,10th,15th,30th,45th,75th minute | |
Secondary | Tpe | Tpeak-Tend | Baseline,Intraoperative 1th,5th,10th,15th,30th,45th,75th minute | |
Secondary | Heart Rate | The investigator will assess the Heart Rate from ECG | Baseline,Intraoperative 1th,5th,10th,15th,30th,45th,75th minute | |
Secondary | Bispektral index | bispectral index measurement | Baseline,Intraoperative 1th,5th,10th,15th,30th,45th,75th minute | |
Secondary | non invaziv systolic blood pressure | non invasive systolic blood pressure measurement | Baseline,Intraoperative 1th,5th,10th,15th,30th,45th,75th minute | |
Secondary | non invaziv diastolic blood pressure | non invasive diastolic blood pressure measurement | Baseline,Intraoperative 1th,5th,10th,15th,30th,45th,75th minute |
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