PropofolNCT05757063
Impact of Two Different Types of Sedation on ICEB
A study testing Sedation with propofol and sedation with dexmedetomidine in people with Propofol and Dexmedetomidine, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Propofol, Dexmedetomidine, Electrophysiological Balance Index
- What is being tested?
- Sedation with propofol and sedation with dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ASA Ⅰ-Ⅱ ,
- 18-80 years old, who will be operated under spinal anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Propofol, Dexmedetomidine, Electrophysiological Balance Index, QT Interval, Variation in, Tp-e Interval, QT Dispersion
- Being tested
- Sedation with propofol, sedation with dexmedetomidine
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedation with propofolOther
After spinal anesthesia, patients will be sedated with propofol.
sedation with dexmedetomidineOther
After spinal anesthesia, patients will be sedated with dexmedetomidine.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | Sedation procedure with propofol Receives: Other: Sedation with propofol |
| Dexmedetomidine | Active comparator | Sedation procudure with dexmedetomidine Receives: Other: sedation with dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICEBc
QTc/QRS formula
Measured: İntraoperative 10th minute
Secondary outcomes (10)
ICEB
Index of cardio-electrophysiological balance (iCEB); calculated as QT distance divided by QRS duration (QT/ QRS), it will be calculated from the ECG.
Measured: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
ICEBc
QTc/QRS formula
Measured: Baseline,İntraoperative 1th,5th,15th,30th,45th,75th minute
QT
The investigator will assess the QT interval
Measured: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
QTc
The investigator will assess the QTc interval
Measured: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
QTd
maxQT-minQT
Measured: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
Tpe
Tpeak-Tend
Measured: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
Heart Rate
The investigator will assess the Heart Rate from ECG
Measured: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
Bispektral index
bispectral index measurement
Measured: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
non invaziv systolic blood pressure
non invasive systolic blood pressure measurement
Measured: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
non invaziv diastolic blood pressure
non invasive diastolic blood pressure measurement
Measured: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start1 Mar 2023
- Primary completion1 Jul 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PropofolStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak NALBANT, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757063
- Sponsor's protocol ID
- ICEB
- Status last verified
- Dec 2023
- First submitted
- 22 Feb 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Two Different Sedation Protocols Used in Patients Undergoing Spinal Anesthesia on Cardiac Electrophysiology
- ClinicalTrials.gov ID
- NCT05757063
- Acronym / sponsor ID
- ICEB
- Conditions
- Propofol, Dexmedetomidine, Electrophysiological Balance Index, QT Interval, Variation in, Tp-e Interval, QT Dispersion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Other: Sedation with propofolSedation procedure with propofol |
| Dexmedetomidine | Active comparator | Other: sedation with dexmedetomidineSedation procudure with dexmedetomidine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with ASA Ⅰ-Ⅱ ,
- 18-80 years old, who will be operated under spinal anesthesia
Key exclusion criteria (8 listed)
- Hypersensitivity to the propofol,dexmedotimidine
- preoperative QTc prolongation
- preoperative heart disease
- use of drugs that affect the QT interval
- severe sinus bradycardia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sedation with propofolAfter spinal anesthesia, patients will be sedated with propofol. | Other | Propofol |
| sedation with dexmedetomidineAfter spinal anesthesia, patients will be sedated with dexmedetomidine. | Other | Dexmedetomidine |
Primary outcome
ICEBc
Time frame: İntraoperative 10th minute
QTc/QRS formula
10 secondary outcomes
ICEB
Time frame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
ICEBc
Time frame: Baseline,İntraoperative 1th,5th,15th,30th,45th,75th minute
QT
Time frame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
QTc
Time frame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
QTd
Time frame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
Tpe
Time frame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
Heart Rate
Time frame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
Bispektral index
Time frame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
non invaziv systolic blood pressure
Time frame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
non invaziv diastolic blood pressure
Time frame: Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedation with propofol and sedation with dexmedetomidine in people with Propofol and Dexmedetomidine, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICEBc (time frame: İntraoperative 10th minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.