Impact of Two Different Types of Sedation on ICEB

Not Applicable

Completed

• Conditions: Propofol; Electrophysiological Balance Index; QT Dispersion; QT Interval, Variation in; Dexmedetomidine; Tp-e Interval; Knee Osteoarthritis
• Interventions: Other: Sedation with propofol; Other: sedation with dexmedetomidine

• Registration Number: NCT05757063
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Study Timeline

• Study First Submitted: 2023-02-22
• Study Start: 2023-03-01
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-07
• Primary Completion: 2023-07-01
• Study Completion: 2023-08-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Sedation with propofol	Sedation procedure with propofol
Dexmedetomidine	sedation with dexmedetomidine	Sedation procudure with dexmedetomidine

Primary Outcome Measures

Name	Time	Method
ICEBc	İntraoperative 10th minute	QTc/QRS formula

Secondary Outcome Measures

Name	Time	Method
non invaziv diastolic blood pressure	Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute	non invasive diastolic blood pressure measurement
ICEB	Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute	Index of cardio-electrophysiological balance (iCEB); calculated as QT distance divided by QRS duration (QT/ QRS), it will be calculated from the ECG.
Tpe	Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute	Tpeak-Tend
QTc	Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute	The investigator will assess the QTc interval
non invaziv systolic blood pressure	Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute	non invasive systolic blood pressure measurement
ICEBc	Baseline,İntraoperative 1th,5th,15th,30th,45th,75th minute	QTc/QRS formula
QT	Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute	The investigator will assess the QT interval
Bispektral index	Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute	bispectral index measurement
QTd	Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute	maxQT-minQT
Heart Rate	Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute	The investigator will assess the Heart Rate from ECG

Trial Locations

Locations (1)

Ankara City Hospital; 🇹🇷 Ankara, Turkey