Impact of Two Different Types of Sedation on ICEB

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Ankara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Propofol; Sedation procedure with propofol	Other: Sedation with propofol; After spinal anesthesia, patients will be sedated with propofol.
Active Comparator: Dexmedetomidine; Sedation procudure with dexmedetomidine	Other: sedation with dexmedetomidine; After spinal anesthesia, patients will be sedated with dexmedetomidine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICEBc	QTc/QRS formula	İntraoperative 10th minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
ICEBc	QTc/QRS formula	Baseline,İntraoperative 1th,5th,15th,30th,45th,75th minute
QT	The investigator will assess the QT interval	Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
QTc	The investigator will assess the QTc interval	Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
QTd	maxQT-minQT	Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
Tpe	Tpeak-Tend	Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
Heart Rate	The investigator will assess the Heart Rate from ECG	Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
Bispektral index	bispectral index measurement	Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
non invaziv systolic blood pressure	non invasive systolic blood pressure measurement	Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
non invaziv diastolic blood pressure	non invasive diastolic blood pressure measurement	Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 7, 2023

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Propofol; Dexmedetomidine
• Other Study ID Numbers: ICEB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No