Effect of Dexmedetomidine on Hemodynamics in Cardiac Surgery

NCT06958913 | Completed DMC

• 1 other identifier: PamukkaleUSyüksel-002
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Creatin kinase MB (IU/L) level for cardiac protective effect

  Creatin kinase MB was recorded 1 day before, 1 hour and 24 hours after surgery.

• Troponin I (ng/mL) level for cardiac protective effect

  Troponin I was recorded 1 day before, 1 hour and 24 hours after surgery.

Study Arms (2)

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.

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.

Drug: Dexmedetomidine

Interventions

Propofol group 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 P

Dexmedetomidine 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.

Group DP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, 20100, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 27716690 BACKGROUND

• 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.

  PMID: 21901330 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Selvinaz Yüksel Tanrıverdi

  Pamukkale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: May 6, 2025
• Study Start: May 5, 2022
• Primary Completion: November 5, 2022
• Study Completion: November 5, 2022
• Last Updated: May 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)