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Trial record 7 of 326 for:    clonidine

Efficacy of Dexmedetomidine Versus Clonidine to Control Delirium in Patients Undergoing CABG

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ClinicalTrials.gov Identifier: NCT03477994
Recruitment Status : Completed
First Posted : March 27, 2018
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Hoda Shokri, Ain Shams University

Brief Summary:

This prospective, randomised, double blinded, controlled clinical trial will be conducted in 147 patients between 60 yr and 70 yr , ASA physical status II and III, undergoing CABG. Patients will be randomly allocated to either dexmedetomidine or clonidine (control) groups .Upon arrival to ICU, in the dexmedetomidine group, patients will receive an infusion of 0.5-0.7 μg/kg/h then 1.4 μg/kg/h if Richmond assessment sedation score from +1 to +4

Taking into consideration if the heart rate less than 60 per minute or persistent hypotension reduce infusion rate by 0.2 μg/kg/h.

Once the patient will be extubated, wean the infusion by 0.1μg/kg/h till reaching 0.2μg/kg/h. Slow the weaning rate if evidence of withdrawal reactions as agitation or hypertension occur. In clonidine group, the patients will receive 0.5μg/kg then 0.1-0.2 μg/kg/h.Primary end point of the study is the incidence of delirium.The secondary endpoints will be the the duration of extubation, the length of ICU stay, need for inotropic support or vasopressors, hospital stay , mean arterial blood pressure and heart rate , hospital mortality rate , all additional sedatives including overall doses of morphine and haloperidol the incidence of adverse events as bradycardia


Condition or disease Intervention/treatment Phase
Delirium on Emergence Drug: Dexmedetomidine Drug: Clonidine Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Dexmedetomidine Versus Clonidine to Control Delirium in Patients Undergoing Coronary Artery Bypass Grafting
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Active Comparator: dexmedetomidine group

Upon arrival to ICU, in the dexmedetomidine group, patients will receive an infusion of 0.5-0.7 μg/kg/h then 1.4 μg/kg/h if Richmond assessment sedation score from +1 to +4

+4 Combative ,+3 Very agitated ,+2 Agitated,+1 Restless, 0 Alert and calm, -1 Drowsy , -2 Light sedation, -3 Moderate sedation, -4 Deep sedation, -5 Unarrousable Taking into consideration if the heart rate less than 60 per minute or persistent hypotension reduce infusion rate by 0.2 μg/kg/h. Once the patient will be extubated, wean the infusion by 0.1μg/kg/h till reaching 0.2μg/kg/h. Slow the weaning rate if evidence of withdrawal reactions as agitation or hypertension occur.

Drug: Dexmedetomidine
an infusion of 0.5-0.7 μg/kg/h then 1.4 μg/kg/h if Richmond assessment sedation score from +1 to +4 ,if the heart rate less than 60 per minute or persistent hypotension reduce infusion rate by 0.2 μg/kg/h.
Other Name: demedetomidine hydrochloride

Sham Comparator: clonidine group
In clonidine group, the patients will receive 0.5μg/kg then 0.1-0.2 μg/kg/h if Richmond assessment sedation score from +1 to +4 Five ampoules of clonidine(750 μg) will be drawn up and diluted in 45ml of normal saline.
Drug: Clonidine
an infusion of 0.5μg/kg then 0.1-0.2 μg/kg/h if Richmond assessment sedation score from +1 to +4.
Other Name: clonidine hydrochloride




Primary Outcome Measures :
  1. the incidence of delirium [ Time Frame: every 4 hours in first day in ICU then every 8h for the next day, after discharge from ICU to the ward it will be checked every 8h for 5 days ]
    disturbed level of consciousness that develops over a period of hours or days and fluctuates over time.


Secondary Outcome Measures :
  1. length of ICU stay [ Time Frame: 2 days ]
    time to stay in ICU discharge to the ward



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Ages Eligible for Study:   60 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

60-70 yrs age ASA II, III Scheduled for CABG -

Exclusion Criteria:

History of mental illness Delirium or dementia patient refusal to participate Emergency procedures Any contraindications to study drugs

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03477994


Locations
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Egypt
Ain Shams university
Cairo, Egypt, 11566
Sponsors and Collaborators
Ain Shams University
Investigators
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Study Chair: Ayman Shoeb, professor Ain Shams University

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Responsible Party: Hoda Shokri, Ain Shams University
ClinicalTrials.gov Identifier: NCT03477994     History of Changes
Other Study ID Numbers: FMASU R 16
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD including protocol will be shared
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: about one year
Access Criteria: prevention of delirium post cardiac surgery

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hoda Shokri, Ain Shams University:
dexmedetomidine, clonidine, postoperative, CABG
Additional relevant MeSH terms:
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Clonidine
Delirium
Emergence Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Postoperative Complications
Pathologic Processes
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
Antihypertensive Agents
Sympatholytics
Autonomic Agents