Clinical trial NCT05757063: Impact of Two Different Types of Sedation on ICEB
Official title: Evaluation of the Effects of Two Different Sedation Protocols Used in Patients Undergoing Spinal Anesthesia on Cardiac Electrophysiology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Propofol
Dexmedetomidine
Electrophysiological Balance Index
QT Interval, Variation in
Tp-e Interval
QT Dispersion
Knee Osteoarthritis
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patients with ASA Ⅰ-Ⅱ ,
* 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

Primary outcomes:
measure: ICEBc
timeFrame: İntraoperative 10th minute
Secondary outcomes:
measure: ICEB
timeFrame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
measure: ICEBc
timeFrame: Baseline,İntraoperative 1th,5th,15th,30th,45th,75th minute
measure: QT
timeFrame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
measure: QTc
timeFrame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
measure: QTd
timeFrame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
measure: Tpe
timeFrame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
measure: Heart Rate
timeFrame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
measure: Bispektral index
timeFrame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
measure: non invaziv systolic blood pressure
timeFrame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
measure: non invaziv diastolic blood pressure
timeFrame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
References: