Effect of Dexmedetomidine on Hemodynamics in Cardiac Surgery

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.

Study Overview

• Status: Completed
• Conditions: Use of Dexmedetomidine in Cardiac Surgery (CABG, Valve Replacement or Total Aortic Arch Replacement)
• Intervention / Treatment: Drug: Propofol group; Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Denizli, Turkey, 20100
    • Pamukkale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group P; 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.	Drug: Propofol group; 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.
Experimental: Group DP; 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.	Drug: Dexmedetomidine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Troponin I was recorded 1 day before, 1 hour and 24 hours after surgery.

Collaborators and Investigators

• Sponsor: Pamukkale University
• Investigators: Principal Investigator: Selvinaz Yüksel Tanrıverdi, Pamukkale University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2022
• Primary Completion (Actual): November 5, 2022
• Study Completion (Actual): November 5, 2022

Study Registration Dates

• First Submitted: April 10, 2025
• First Submitted That Met QC Criteria: April 26, 2025
• First Posted (Actual): May 6, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: April 26, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexmedetomidine; Propofol
• Other Study ID Numbers: PamukkaleUSyüksel-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No