Effect of Dexmedetomidine on Hemodynamics in Cardiac Surgery

NCT ID: NCT06958913

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-05
• Study Completion Date: 2022-11-05

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.

Conditions

Use of Dexmedetomidine in Cardiac Surgery (CABG, Valve Replacement or Total Aortic Arch Replacement)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Propofol group

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Selvinaz Yüksel Tanrıverdi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Selvinaz Yüksel Tanrıverdi

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Locations

Pamukkale University

Denizli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 27716690 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21901330 (View on PubMed)

Other Identifiers

PamukkaleUSyüksel-002

Identifier Type: -

Identifier Source: org_study_id