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

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

Tracking Information
First Submitted Date  ICMJE January 18, 2022
First Posted Date  ICMJE February 1, 2022
Last Update Posted Date February 1, 2022
Actual Study Start Date  ICMJE January 1, 2021
Estimated Primary Completion Date February 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2022)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hemodynamic Effect of Dexmedetomidine Alone With Dexmedetomidine Plus Ketamine Combination in CABG
Official Title  ICMJE Comparing the Hemodynamic Effect of Dexmedetomidine Alone With Dexmedetomidine Plus Ketamine Combination in Post Cardiac Surgery Patients: A Randomized Controlled Trial
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Hemodynamic Instability
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: DA
    Group DA: will be assigned to patients in whom dexmedetomidine alone will be used.
    Intervention: Drug: Dexmedetomidine alone
  • Experimental: KD
    Group KD: will be assigned to patients receiving ketamine plus dexmedetomidine.
    Intervention: Drug: Dexmedetomidine alone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 28, 2022)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2022
Estimated Primary Completion Date February 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05218161
Other Study ID Numbers  ICMJE CPEIC No. 153
153 ( Registry Identifier: CPEIC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Shumaila rai, Chaudhry Pervaiz Elahi Institute of Cardiology
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Chaudhry Pervaiz Elahi Institute of Cardiology
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr Shumaila Rai, FCPS Chaudhry Pervaiz Elahi Institute of Cardiology
PRS Account Chaudhry Pervaiz Elahi Institute of Cardiology
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP