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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date December 2023
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Seventy patients who underwent operation under regional anesthesia and received intraoperative sedation will be included in the study. The patients will be divided into two groups, Group D (dexmedetomidine) and Group P (propofol). Sedative agent infusion will be started immediately after spinal anesthesia is administered. Preoperative ASA (American Society of Anesthesiologists) scores, demographic data, comorbidities and medications used will be recorded. Vitals and ECG prior to spinal anesthesia will be recorded. After that, spinal anesthesia will be applied and vitals and ECG will be recorded at 1, 5, 10, 15, 45 and 75 minutes. The sedation levels of the patients will be measured noninvasively by bispectral index (BIS) monitoring. Patients will be kept within the limits of light sedation. The maximum dose of 1.4 micrograms/kg/hour in the dexmedetomidine group (group D, n=35) and 4.5 milligrams/kg/hour in the propofol group (group P, n=35) will not be exceeded. The following parameters were set as the safety endpoint during sedation: - Respiratory rate ≤8 - SpO2; 95 - Heart rate; 40 - Systolic blood pressure;80 At these endpoints, the patient's sedation dose will be reduced regardless of the BIS value. During sedation, patients will be given 3 liters of nasal oxygen per minute, which can be increased according to need. Just before and 1st, 5th, 10th, 15th, 45th, 75th minutes after spinal anesthesia systolic arterial pressure, diastolic arterial pressure, mean arterial pressure,peak heart rate, oxygen saturation, bispectral index, QT time, QTc, QT distribution, Tpe, iCEB will be evaluated.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
Sedation with propofol
After spinal anesthesia, patients will be sedated with propofol.
sedation with dexmedetomidine
After spinal anesthesia, patients will be sedated with dexmedetomidine.

Locations

Country Name City State
Turkey Ankara City Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

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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