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History of Changes for Study: NCT05218161
Hemodynamic Effect of Dexmedetomidine Alone With Dexmedetomidine Plus Ketamine Combination in CABG
Latest version (submitted January 28, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 28, 2022 None (earliest Version on record)
Comparison Format:

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Study NCT05218161
Submitted Date:  January 28, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: CPEIC No. 153
Brief Title: Hemodynamic Effect of Dexmedetomidine Alone With Dexmedetomidine Plus Ketamine Combination in CABG
Official Title: Comparing the Hemodynamic Effect of Dexmedetomidine Alone With Dexmedetomidine Plus Ketamine Combination in Post Cardiac Surgery Patients: A Randomized Controlled Trial
Secondary IDs: 153 [Registry Identifier: CPEIC]
Open or close this module Study Status
Record Verification: January 2022
Overall Status: Active, not recruiting
Study Start: January 1, 2021
Primary Completion: February 1, 2022 [Anticipated]
Study Completion: March 1, 2022 [Anticipated]
First Submitted: January 18, 2022
First Submitted that
Met QC Criteria:
January 28, 2022
First Posted: February 1, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
January 28, 2022
Last Update Posted: February 1, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Chaudhry Pervaiz Elahi Institute of Cardiology
Responsible Party: Principal Investigator
Investigator: Shumaila rai
Official Title: Consultant anesthetist
Affiliation: Chaudhry Pervaiz Elahi Institute of Cardiology
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.
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.
Open or close this module Conditions
Conditions: Hemodynamic Instability
Keywords: Cardiac Surgery
Dexmedetomidine
Extubation
Hemodynamics
Ketamine
Fentanyl
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Supportive Care
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module 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.

Open or close this module Eligibility
Minimum Age: 20 Years
Maximum Age: 60 Years
Sex: All
Gender Based:
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.

Open or close this module Contacts/Locations
Study Officials: Dr Shumaila Rai, FCPS
Principal Investigator
Chaudhry Pervaiz Elahi Institute of Cardiology
Locations: Pakistan
CPEIC
Multan, Pakistan
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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