Clinical trial NCT06958913: Effect of Dexmedetomidine on Hemodynamics in Cardiac Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Use of Dexmedetomidine in Cardiac Surgery (CABG, Valve Replacement or Total Aortic Arch Replacement)
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Effect of dexmedetomidine on systolic blood pressure (SBP mm/hg)
timeFrame: 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.
measure: Effect of dexmedetomidine on diastolic blood pressure (DBP mm/hg)
timeFrame: 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.
measure: Effect of dexmedetomidine on heart rate (HR bpm)
timeFrame: 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.
measure: Effect of dexmedetomidine on mean arterial pressure (MAP mm/hg)
timeFrame: 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:
measure: Creatin kinase MB (IU/L) level for cardiac protective effect
timeFrame: Creatin kinase MB was recorded 1 day before, 1 hour and 24 hours after surgery.
measure: Troponin I (ng/mL) level for cardiac protective effect
timeFrame: Troponin I was recorded 1 day before, 1 hour and 24 hours after surgery.
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Selvinaz Yüksel Tanrıverdi
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kunisawa 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.