Hemodynamic Effect of Dexmedetomidine Alone With Dexmedetomidine Plus Ketamine Combination in CABG

• ClinicalTrials.gov Identifier: NCT05218161
• Recruitment Status: Active, not recruiting
• First Posted: February 1, 2022
• Last Update Posted: February 1, 2022
• Sponsor: Chaudhry Pervaiz Elahi Institute of Cardiology
• Information provided by (Responsible Party): Shumaila rai, Chaudhry Pervaiz Elahi Institute of Cardiology

Study Description

Brief Summary:

In post cardiac surgery, many cardiovascular and other complications may occur that lead to increase in mortality and hospital stays. Meticulous perioperative management is important to avoid these adverse events. Tachycardia is the main cause of post coronary artery bypass graft (CABG) myocardial ischemia which can be decreased by sedation and analgesia.

Condition or disease	Intervention/treatment	Phase
Hemodynamic Instability	Drug: Dexmedetomidine alone	Not Applicable

Detailed Description:

Dexmedetomidine is a highly specific alpha 2 adrenoreceptor agonist. Its sedative effect results from stimulation of alpha 2 adrenoreceptors in the central nervous system (in the locus coeruleus) independent of GABA system contrary to other drugs.Dexmedetomidine has better sedative effect and similar respiratory and hemodynamic effects to midazolam. It does not depress respiratory drive or decrease arterial oxygen saturation so intravenous (IV) continuous sedation with dexmedetomidine does not change the normal course of ventilator weaning and extubation. It produces a unique EEG pattern of sleep that closely resembles that of normal physiological sleep that allows easy arousal. Dexmedetomidine also has analgesic effect. All these properties make dexmedetomidine a first line drug for the cooperative sedation management in the Intensive Care Unit (ICU). Ketamine is a phencyclidine nonbarbiturate derivative that binds with N methyl d aspartate and sigma opioid receptors to produce dissociative anesthesia, analgesia, and amnesia with little or no respiratory or cardiovascular depression. Ketamine inhibits endothelial nitric oxide production leading to positive inotropic action and vasoconstriction which preserves hemodynamic stability. Dexmedetomidine can effectively and safely attenuate the ketamine induced hemodynamic pressor response and psychomimetic effects. Dexmedetomidine expected to prevent the tachycardia, hypertension, salivation, and emergence phenomena associated with ketamine. Ketamine may prevent the bradycardia and hypotension that have been reported with dexmedetomidine. Review of literature has shown that there are very few studies present on the comparison of combination of Ketamine and dexmedetomidine with dexmedetomidine alone especially in post cardiac surgery patients and therefore further studies are required to ascertain the role of dexmedetomidine in terms of hemodynamic effects after cardiac surgery.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Comparing the Hemodynamic Effect of Dexmedetomidine Alone With Dexmedetomidine Plus Ketamine Combination in Post Cardiac Surgery Patients: A Randomized Controlled Trial
• Actual Study Start Date: January 1, 2021
• Estimated Primary Completion Date: February 1, 2022
• Estimated Study Completion Date: March 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: DA; Group DA: will be assigned to patients in whom dexmedetomidine alone will be used.	Drug: Dexmedetomidine alone; All the patients in group DA will be sedated using dexmedetomidine 1mcg/kg IV bolus, followed by 0.3-0.7mcg/kg/h infusion to maintain Ramsay sedation score ≥4 during assisted ventilation.
Experimental: KD; Group KD: will be assigned to patients receiving ketamine plus dexmedetomidine.	Drug: Dexmedetomidine alone; All the patients in group DA will be sedated using dexmedetomidine 1mcg/kg IV bolus, followed by 0.3-0.7mcg/kg/h infusion to maintain Ramsay sedation score ≥4 during assisted ventilation.

Outcome Measures

Primary Outcome Measures :

1. Hemodynamic stability [ Time Frame: 06 months ]

   Hemodynamic stability:If blood pressure and heart rate are with in appropriate limits,it will be considered as hemodynamically stable.

   Blood pressure:MAP>65 mmhg is considered stable. Heart rate:80-100 bpm is considered stable.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Patients of 40-60 years old Hemodynamically stable with normal or moderately impaired left ventricular function Ejection fraction >40% that underwent elective surgery CABG surgery for single vessel

Exclusion Criteria:

Hemodynamic instability intraoperative. Patients on moderate to high vasopressors or ionotropes. Ejection fraction less than 40%. Off pump surgery. Patient on mechanical supports.

Contacts and Locations

Locations

Pakistan

CPEIC

Multan, Pakistan

Sponsors and Collaborators

Chaudhry Pervaiz Elahi Institute of Cardiology

Investigators

• Principal Investigator: Dr Shumaila Rai, FCPS; Chaudhry Pervaiz Elahi Institute of Cardiology

More Information

• Responsible Party: Shumaila rai, Consultant anesthetist, Chaudhry Pervaiz Elahi Institute of Cardiology
• ClinicalTrials.gov Identifier: NCT05218161
• Other Study ID Numbers: CPEIC No. 153; 153 ( Registry Identifier: CPEIC )
• First Posted: February 1, 2022
• Last Update Posted: February 1, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shumaila rai, Chaudhry Pervaiz Elahi Institute of Cardiology:

Cardiac Surgery; Dexmedetomidine; Extubation; Hemodynamics; Ketamine; Fentanyl

Additional relevant MeSH terms:

Dexmedetomidine; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action