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

NCT03477994 | Completed

• 1 other identifier: FMASU R 16
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

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

Conditions

Delirium on Emergence

Keywords

dexmedetomidine, clonidine, postoperative, CABG

Outcome Measures

Primary Outcomes (1)

• the incidence of delirium

  disturbed level of consciousness that develops over a period of hours or days and fluctuates over time.

  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

Secondary Outcomes (1)

• length of ICU stay

  2 days

Study Arms (2)

dexmedetomidine group

ACTIVE COMPARATOR

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

clonidine group

SHAM COMPARATOR

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

Interventions

Dexmedetomidine DRUG

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.

Also known as: demedetomidine hydrochloride

dexmedetomidine group

Clonidine DRUG

an infusion of 0.5μg/kg then 0.1-0.2 μg/kg/h if Richmond assessment sedation score from +1 to +4.

Also known as: clonidine hydrochloride

clonidine group

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• yrs age ASA II, III Scheduled for CABG -

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university

Cairo, 11566, Egypt

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Clonidine

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ayman Shoeb, professor

  Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hoda Shokri

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 27, 2018
• Study Start: December 1, 2018
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: July 11, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: about one year
• Access Criteria: prevention of delirium post cardiac surgery

Locations

EG (1)