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Completed

NCT Number: NCT05757063

Impact of Two Different Types of Sedation on ICEB

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.

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Key information

Conditions

Propofol Arthritis Dexmedetomidine Electrophysiological Balance Index Joint Diseases Knee Osteoarthritis Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee QT Dispersion Qt Interval, Variation in Rheumatic Diseases Tp-e Interval

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara City Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sedation with propofol

Other

After spinal anesthesia, patients will be sedated with propofol.

sedation with dexmedetomidine

Other

After spinal anesthesia, patients will be sedated with dexmedetomidine.

Primary outcomes

  1. ICEBc

    Time frame: İntraoperative 10th minute

    QTc/QRS formula

Secondary outcomes

  1. ICEB

    Time frame: 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.

  2. ICEBc

    Time frame: Baseline,İntraoperative 1th,5th,15th,30th,45th,75th minute

    QTc/QRS formula

  3. QT

    Time frame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute

    The investigator will assess the QT interval

  4. QTc

    Time frame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute

    The investigator will assess the QTc interval

  5. QTd

    Time frame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute

    maxQT-minQT

  6. Tpe

    Time frame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute

    Tpeak-Tend

  7. Heart Rate

    Time frame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute

    The investigator will assess the Heart Rate from ECG

  8. Bispektral index

    Time frame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute

    bispectral index measurement

  9. non invaziv systolic blood pressure

    Time frame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute

    non invasive systolic blood pressure measurement

  10. non invaziv diastolic blood pressure

    Time frame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute

    non invasive diastolic blood pressure measurement

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 7, 2023
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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