Impact of Two Different Types of Sedation on ICEB
Primary Purpose
Propofol, Dexmedetomidine, Electrophysiological Balance Index
Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sedation with propofol
sedation with dexmedetomidine
Sponsored by
About this trial
This is an interventional treatment trial for Propofol
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
Sites / Locations
- Ankara City Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Propofol
Dexmedetomidine
Arm Description
Sedation procedure with propofol
Sedation procudure with dexmedetomidine
Outcomes
Primary Outcome Measures
ICEBc
QTc/QRS formula
Secondary Outcome Measures
ICEB
Index of cardio-electrophysiological balance (iCEB); calculated as QT distance divided by QRS duration (QT/ QRS), it will be calculated from the ECG.
ICEBc
QTc/QRS formula
QT
The investigator will assess the QT interval
QTc
The investigator will assess the QTc interval
QTd
maxQT-minQT
Tpe
Tpeak-Tend
Heart Rate
The investigator will assess the Heart Rate from ECG
Bispektral index
bispectral index measurement
non invaziv systolic blood pressure
non invasive systolic blood pressure measurement
non invaziv diastolic blood pressure
non invasive diastolic blood pressure measurement
Full Information
NCT ID
NCT05757063
First Posted
February 22, 2023
Last Updated
March 3, 2023
Sponsor
Ankara City Hospital Bilkent
1. Study Identification
Unique Protocol Identification Number
NCT05757063
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara City Hospital Bilkent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Propofol, Dexmedetomidine, Electrophysiological Balance Index, QT Interval, Variation in, Tp-e Interval, QT Dispersion, Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
Sedation procedure with propofol
Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Description
Sedation procudure with dexmedetomidine
Intervention Type
Other
Intervention Name(s)
Sedation with propofol
Intervention Description
After spinal anesthesia, patients will be sedated with propofol.
Intervention Type
Other
Intervention Name(s)
sedation with dexmedetomidine
Intervention Description
After spinal anesthesia, patients will be sedated with dexmedetomidine.
Primary Outcome Measure Information:
Title
ICEBc
Description
QTc/QRS formula
Time Frame
İntraoperative 10th minute
Secondary Outcome Measure Information:
Title
ICEB
Description
Index of cardio-electrophysiological balance (iCEB); calculated as QT distance divided by QRS duration (QT/ QRS), it will be calculated from the ECG.
Time Frame
Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
Title
ICEBc
Description
QTc/QRS formula
Time Frame
Baseline,İntraoperative 1th,5th,15th,30th,45th,75th minute
Title
QT
Description
The investigator will assess the QT interval
Time Frame
Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
Title
QTc
Description
The investigator will assess the QTc interval
Time Frame
Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
Title
QTd
Description
maxQT-minQT
Time Frame
Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
Title
Tpe
Description
Tpeak-Tend
Time Frame
Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
Title
Heart Rate
Description
The investigator will assess the Heart Rate from ECG
Time Frame
Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
Title
Bispektral index
Description
bispectral index measurement
Time Frame
Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
Title
non invaziv systolic blood pressure
Description
non invasive systolic blood pressure measurement
Time Frame
Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
Title
non invaziv diastolic blood pressure
Description
non invasive diastolic blood pressure measurement
Time Frame
Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
selvinaz durantas
Phone
+905545053548
Email
selvinaz3355@gmail.com
Facility Information:
Facility Name
Ankara City Hospital
City
Ankara
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Two Different Types of Sedation on ICEB
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