Use of Dexmedetomidine in Cardiac Surgery (CABG, Valve Replacement or Total Aortic Arch Replacement)NCT06958913
Effect of Dexmedetomidine on Hemodynamics in Cardiac Surgery
A study testing Propofol group and Dexmedetomidine in people with Use of Dexmedetomidine in Cardiac Surgery (CABG, Valve Replacement or Total Aortic Arch Replacement), run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
It is important to establish a stable haemodynamics in patients undergoing cardiac surgery. Haemodynamic depression is common during induction of anaesthesia [1]. Sympathetic response due to tracheal intubation creates unwanted hypertensive responses on haemodynamics. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Use of Dexmedetomidine in Cardiac Surgery (CABG, Valve Replacement or Total Aortic Arch Replacement)
- What is being tested?
- Propofol group and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2022to 5 Nov 2022
- 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 over 18 years of age who underwent cardiovascular surgery (coronary artery bypass grafting, valve replacement or total aortic arch replacement) for ischaemic heart disease, valvular disease or aortic arch aneurysm were included.
Who cannot join
- Severe cardiovascular disease [(NYHA class 4 or left ventricular ejection fraction (LVEF) less than 30%)] ,
- Concomitant systemic disorders (e.g. patients with severe liver dysfunction or chronic renal failure on haemodialysis),
- Pregnant women,
- Emergency cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Hemodynamic Response and Cardiac Protective Effects of Propofol Versus Dexmedetomidine at Induction of Anesthesia in Cardiac Surgery: a Randomized Controlled Trial
It is important to establish a stable haemodynamics in patients undergoing cardiac surgery. Haemodynamic depression is common during induction of anaesthesia [1]. Sympathetic response due to tracheal intubation creates unwanted hypertensive responses on haemodynamics. Dexmedetomidine decreases stress responses and may provide a stable haemodynamics in situations such as surgery or induction of anaesthesia [2-4]. It may increase the tendency to hypotension and bradycardia by weakening the hyperdynamic response caused by sympathetic effect [5,6]. Concurrent use of dexmedetomidine may reduce anaesthetic opioid doses and provide more stable haemodynamics on systolic arterial pressure in patients undergoing CABG [7].
During cardiopulmonary bypass, dexmedetomidine may provide myocardial protection by exerting anti-inflammatory effects and may be beneficial for rapid recovery [6,8,9]. In cardiac surgery, dexmedetomidine provided bidirectional regulation of the anti-inflammatory response in which it showed antioxidant properties by inhibiting proinflammatory cytokine production and lipid peroxidation [10,11]. Dexmedetomidine in combination with propofol resulted in lower myocardial enzyme values than propofol alone [12]. The cardioprotective effects of propofol are dose-dependent; however, haemodynamic instability may be a concern at higher doses. In addition, dexmedetomidine may be considered a valid alternative to propofol, mainly because of its haemodynamic stability and possible myocardial protective effects [13]. It has been shown that dexmedetomidine pretreatment in valvular heart surgery can reduce the dose of propofol and the duration of mechanical ventilation and provide myocardial protection without an increase in adverse events [14]. Our study had two aims. The first was to provide a more stable haemodynamics by adding dexmedetomidine to induction in open cardiovascular surgery anaesthesia. Hypotension during induction and hypertensive response during tracheal intubation were tried to decrease. The second was to evaluate the effect of dexmedetomidine on cardiac enzymes only during induction, i.e. to evaluate its cardiac protective efficacy.
- Conditions
- Use of Dexmedetomidine in Cardiac Surgery (CABG, Valve Replacement or Total Aortic Arch Replacement)
- Being tested
- Propofol group, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol groupDrug
In group P, 0.125 cc/kg saline infusion was administered in 10 minutes. Fentanyl was administered at a dose of 3 mcg/kg at 5 minutes of this application. Then propofol was administered until the eyelash reflex disappeared and the BIS value was 40. 0.6 mg/kg rocuronium was administered to facilitate intubation. All patients received 8 mg dexamethasone and lidocaine at a dose of 1 mg/kg.
DexmedetomidineDrug
In group DP, dexmedetomidine at a dose of 0.5 mck/kg was administered over 10 minutes. At the 5th minute of this infusion, fentanyl was administered at a dose of 3 mcg/kg. Propofol was added until the BIS value was 40. The patients received 0.6 mg/kg rocuronium, 8 mg dexamethasone, and 1 mg/kg lidocaine.
| Study group | Role | What they receive |
|---|---|---|
| Group P | Active comparator | In group P, 0.125 cc/kg saline infusion was administered in 10 minutes. Fentanyl was administered at a dose of 3 mcg/kg at 5 minutes of this application. Then propofol was administered until the eyelash reflex disappeared and the BIS value was 40. 0.6 mg/kg rocuronium was administered to facilitate intubation. All patients received 8 mg dexamethasone and lidocaine at a dose of 1 mg/kg. Receives: Drug: Propofol group |
| Group DP | Experimental | In group DP, dexmedetomidine at a dose of 0.5 mck/kg was administered over 10 minutes. At the 5th minute of this infusion, fentanyl was administered at a dose of 3 mcg/kg. Propofol was added until the BIS value was 40. The patients received 0.6 mg/kg rocuronium, 8 mg dexamethasone, and 1 mg/kg lidocaine. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of dexmedetomidine on systolic blood pressure (SBP mm/hg)
Datawere (SBP mm/hg) recorded during induction, before intubation, after intubation and before the start of surgery.
Measured: SBP was recorded as the first basal value after monitoring of the patient. Data were recorded at 5 and 10 minutes after the start of induction and just before intubation. The highest value in the first 5 minutes after intubation was recorded.
Effect of dexmedetomidine on diastolic blood pressure (DBP mm/hg)
Datawere(DBP mm/hg) recorded during induction, before intubation, after intubation and before the start of surgery.
Measured: DBP was recorded as the first basal value after monitoring of the patient. Data were recorded at 5 and 10 minutes after the start of induction and just before intubation. The highest value in the first 5 minutes after intubation was recorded.
Effect of dexmedetomidine on heart rate (HR bpm)
Datawere (HR bpm) recorded during induction, before intubation, after intubation and before the start of surgery.
Measured: HR was recorded as the first basal value after monitoring of the patient. Data were recorded at 5 and 10 minutes after the start of induction and just before intubation. The highest value in the first 5 minutes after intubation was recorded.
Effect of dexmedetomidine on mean arterial pressure (MAP mm/hg)
Datawere (MAP mm/hg) recorded during induction, before intubation, after intubation and before the start of surgery.
Measured: MAP was recorded as the first basal value after monitoring of the patient. Data were recorded at 5 and 10 minutes after the start of induction and just before intubation. The highest value in the first 5 minutes after intubation was recorded.
Secondary outcomes (2)
Creatin kinase MB (IU/L) level for cardiac protective effect
To evaluate the cardiac protective efficacy of dexmedetomidine, cardiac enzyme CKMB (IU/L) was recorded preoperatively, postoperative 1st hour and 24th hour.
Measured: Creatin kinase MB was recorded 1 day before, 1 hour and 24 hours after surgery.
Troponin I (ng/mL) level for cardiac protective effect
To evaluate the cardiac protective efficacy of dexmedetomidine, cardiac enzyme Troponin I (ng/mL) was recorded preoperatively, postoperative 1st hour and 24th hour.
Measured: Troponin I was recorded 1 day before, 1 hour and 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start5 May 2022
- Primary completion5 Nov 2022
- Study completion5 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Use of Dexmedetomidine in Cardiac Surgery (CABG, Valve Replacement or Total Aortic Arch Replacement)Studies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selvinaz Yüksel Tanrıverdi, Pamukkale University
- Investigators
- Selvinaz Yüksel Tanrıverdi, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958913
- Sponsor's protocol ID
- PamukkaleUSyüksel-002
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Soliman R, Zohry G. The myocardial protective effect of dexmedetomidine in high-risk patients undergoing aortic vascular surgery. Ann Card Anaesth. 2016 Oct-Dec;19(4):606-613. doi: 10.4103/0971-9784.191570.
PubMed 27716690Kunisawa T, Ueno M, Kurosawa A, Nagashima M, Hayashi D, Sasakawa T, Suzuki A, Takahata O, Iwasaki H. Dexmedetomidine can stabilize hemodynamics and spare anesthetics before cardiopulmonary bypass. J Anesth. 2011 Dec;25(6):818-22. doi: 10.1007/s00540-011-1215-3. Epub 2011 Sep 8.
PubMed 21901330
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hemodynamic Response and Cardiac Protective Effects of Propofol Versus Dexmedetomidine at Induction of Anesthesia in Cardiac Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06958913
- Acronym / sponsor ID
- PamukkaleUSyüksel-002
- Conditions
- Use of Dexmedetomidine in Cardiac Surgery (CABG, Valve Replacement or Total Aortic Arch Replacement)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 5 Nov 2022 (actual)
- Study completion
- 5 Nov 2022 (actual)
- First posted
- 6 May 2025 (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.
It is important to establish a stable haemodynamics in patients undergoing cardiac surgery. Haemodynamic depression is common during induction of anaesthesia [1]. Sympathetic response due to tracheal intubation creates unwanted hypertensive responses on haemodynamics. Dexmedetomidine decreases stress responses and may provide a stable haemodynamics in situations such as surgery or induction of anaesthesia [2-4]. It may increase the tendency to hypotension and bradycardia by weakening the hyperdynamic response caused by sympathetic effect [5,6]. Concurrent use of dexmedetomidine may reduce anaesthetic opioid doses and provide more stable haemodynamics on systolic arterial pressure in patients undergoing CABG [7].
During cardiopulmonary bypass, dexmedetomidine may provide myocardial protection by exerting anti-inflammatory effects and may be beneficial for rapid recovery [6,8,9]. In cardiac surgery, dexmedetomidine provided bidirectional regulation of the anti-inflammatory response in which it showed antioxidant properties by inhibiting proinflammatory cytokine production and lipid peroxidation [10,11]. Dexmedetomidine in combination with propofol resulted in lower myocardial enzyme values than propofol alone [12]. The cardioprotective effects of propofol are dose-dependent; however, haemodynamic instability may be a concern at higher doses. In addition, dexmedetomidine may be considered a valid alternative to propofol, mainly because of its haemodynamic stability and possible myocardial protective effects [13]. It has been shown that dexmedetomidine pretreatment in valvular heart surgery can reduce the dose of propofol and the duration of mechanical ventilation and provide myocardial protection without an increase in adverse events [14]. Our study had two aims. The first was to provide a more stable haemodynamics by adding dexmedetomidine to induction in open cardiovascular surgery anaesthesia. Hypotension during induction and hypertensive response during tracheal intubation were tried to decrease. The second was to evaluate the effect of dexmedetomidine on cardiac enzymes only during induction, i.e. to evaluate its cardiac protective efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group P | Active comparator | Drug: Propofol groupIn group P, 0.125 cc/kg saline infusion was administered in 10 minutes. Fentanyl was administered at a dose of 3 mcg/kg at 5 minutes of this application. Then propofol was administered until the eyelash reflex disappeared and the BIS value was 40. 0.6 mg/kg rocuronium was administered to facilitate intubation. All patients received 8 mg dexamethasone and lidocaine at a dose of 1 mg/kg. |
| Group DP | Experimental | Drug: DexmedetomidineIn group DP, dexmedetomidine at a dose of 0.5 mck/kg was administered over 10 minutes. At the 5th minute of this infusion, fentanyl was administered at a dose of 3 mcg/kg. Propofol was added until the BIS value was 40. The patients received 0.6 mg/kg rocuronium, 8 mg dexamethasone, and 1 mg/kg lidocaine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years of age who underwent cardiovascular surgery (coronary artery bypass grafting, valve replacement or total aortic arch replacement) for ischaemic heart disease, valvular disease or aortic arch aneurysm were included.
Key exclusion criteria (4 listed)
- Severe cardiovascular disease [(NYHA class 4 or left ventricular ejection fraction (LVEF) less than 30%)] ,
- Concomitant systemic disorders (e.g. patients with severe liver dysfunction or chronic renal failure on haemodialysis),
- Pregnant women,
- Emergency cases
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 |
|---|---|---|
| Propofol groupIn group P, 0.125 cc/kg saline infusion was administered in 10 minutes. Fentanyl was administered at a dose of 3 mcg/kg at 5 minutes of this application. Then propofol was administered until the eyelash reflex disappeared and the BIS value was 40. 0.6 mg/kg rocuronium was administered to facilitate intubation. All patients received 8 mg dexamethasone and lidocaine at a dose of 1 mg/kg. | Drug | Group P |
| DexmedetomidineIn group DP, dexmedetomidine at a dose of 0.5 mck/kg was administered over 10 minutes. At the 5th minute of this infusion, fentanyl was administered at a dose of 3 mcg/kg. Propofol was added until the BIS value was 40. The patients received 0.6 mg/kg rocuronium, 8 mg dexamethasone, and 1 mg/kg lidocaine. | Drug | Group DP |
Primary outcome
Effect of dexmedetomidine on systolic blood pressure (SBP mm/hg)
Time frame: SBP was recorded as the first basal value after monitoring of the patient. Data were recorded at 5 and 10 minutes after the start of induction and just before intubation. The highest value in the first 5 minutes after intubation was recorded.
Datawere (SBP mm/hg) recorded during induction, before intubation, after intubation and before the start of surgery.
Effect of dexmedetomidine on diastolic blood pressure (DBP mm/hg)
Time frame: DBP was recorded as the first basal value after monitoring of the patient. Data were recorded at 5 and 10 minutes after the start of induction and just before intubation. The highest value in the first 5 minutes after intubation was recorded.
Datawere(DBP mm/hg) recorded during induction, before intubation, after intubation and before the start of surgery.
Effect of dexmedetomidine on heart rate (HR bpm)
Time frame: HR was recorded as the first basal value after monitoring of the patient. Data were recorded at 5 and 10 minutes after the start of induction and just before intubation. The highest value in the first 5 minutes after intubation was recorded.
Datawere (HR bpm) recorded during induction, before intubation, after intubation and before the start of surgery.
Effect of dexmedetomidine on mean arterial pressure (MAP mm/hg)
Time frame: MAP was recorded as the first basal value after monitoring of the patient. Data were recorded at 5 and 10 minutes after the start of induction and just before intubation. The highest value in the first 5 minutes after intubation was recorded.
Datawere (MAP mm/hg) recorded during induction, before intubation, after intubation and before the start of surgery.
2 secondary outcomes
Creatin kinase MB (IU/L) level for cardiac protective effect
Time frame: Creatin kinase MB was recorded 1 day before, 1 hour and 24 hours after surgery.
Troponin I (ng/mL) level for cardiac protective effect
Time frame: Troponin I was recorded 1 day before, 1 hour and 24 hours after surgery.
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 6 May 2025.
- Background: PubMed 27716690Soliman R, Zohry G. The myocardial protective effect of dexmedetomidine in high-risk patients undergoing aortic vascular surgery. Ann Card Anaesth. 2016 Oct-Dec;19(4):606-613. doi: 10.4103/0971-9784.191570.
- Background: PubMed 21901330Kunisawa T, Ueno M, Kurosawa A, Nagashima M, Hayashi D, Sasakawa T, Suzuki A, Takahata O, Iwasaki H. Dexmedetomidine can stabilize hemodynamics and spare anesthetics before cardiopulmonary bypass. J Anesth. 2011 Dec;25(6):818-22. doi: 10.1007/s00540-011-1215-3. Epub 2011 Sep 8.
- Individual participant dataSharing planned: No
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.
Selvinaz Yüksel Tanrıverdi principal investigator
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol group and Dexmedetomidine in people with Use of Dexmedetomidine in Cardiac Surgery (CABG, Valve Replacement or Total Aortic Arch Replacement), run by Pamukkale University 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 1 inclusion and 4 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 6 May 2025. 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?
Effect of dexmedetomidine on systolic blood pressure (SBP mm/hg) (time frame: SBP was recorded as the first basal value after monitoring of the patient. Data were recorded at 5 and 10 minutes after the start of induction and just before intubation. The highest value in the first 5 minutes after intubation was recorded.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06958913, which also lists 2 linked publications.
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 6 May 2025.