Impact of Two Different Types of Sedation on ICEB

Knee Osteoarthritis Clinical Trial

Official title:

Evaluation of the Effects of Two Different Sedation Protocols Used in Patients Undergoing Spinal Anesthesia on Cardiac Electrophysiology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05757063
• Other study ID #: ICEB
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dexmedetomidine
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Propofol
• QT Interval, Variation in

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