Dexmedetomidine vs Control on Attenuation Hemodynamic Response to Noxious Stimuli in CABG Surgical Patients

Not Applicable

Not yet recruiting

• Conditions: CABG
• Interventions: Drug: Dexmedetomidine; Drug: Normal saline

• Registration Number: NCT06238011
• Lead Sponsor: Sawanpracharak hospital

Brief Summary

Aim to study efficacy of dexmedetomidine to attenuate hemodynamic response to intubation, skin incision, sternotomy and aortic cannulation

Detailed Description

A randomized controlled trial was conduct between January2024 and March2024 at Sawanpracharak hospital, Thailand. Of 60 patients undergoing elective coronary artery bypass graft, 30 were assigned to group dexmedetomidine and 30 to group control. Dexmedetomidine prepared by anesthetist nurse in concentration 0.1 microgram/kg/ml total volume 50 ml. loading dose 60 ml/hour for 10 minutes before induction of anesthesia then 5ml/hour until the patient on cardiopulmonary bypass (loading dose 1 microgram/kg for 10 minutes then 0.5 microgram/kg/hour). Group control receive normal saline 60ml/hour for 10minutes then 5 ml/hour

Study Timeline

• Study First Submitted: 2024-01-15
• Study First Submitted QC: 2024-01-24
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Study First Posted: 2024-02-02
• Last Update Posted: 2024-02-05
• Study Start: 2024-02-28
• Primary Completion: 2024-04-30
• Study Completion: 2024-05-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients schedule for CABG
• American Society of Anesthesiologist (ASA) class II-III

Exclusion Criteria

• anticipated difficult intubation
• body mass index> 30 kg/m2
• Ejection Fraction < 40%
• left main coronary artery occlusion >50%
• left bundle branch block
• severe valvular heart disease
• severe pulmonary, renal, hepatic disease
• neurologic disease
• preoperative medication with methyldopa or clonidine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Dexmedetomidine	Patient in this arm will receive dexmedetomidine loading 60ml/hour before induction of anesthesia then 5ml/hour until the patient on cardiopulmonary bypass
Normal Saline	Normal saline	Patient in this arm will receive normal saline loading 60ml/hour before induction of anesthesia then 5ml/hour until the patient on cardiopulmonary artery bypass

Primary Outcome Measures

Name	Time	Method
heart rate, blood pressure(systolic blood pressure, diastolic blood pressure, mean blood pressure)	during surgery	1. heart rate in beat per minute 1.1just after loading dose 1.2 before intubation 1.3at1,3,5 minute after intubation 1.4 before skin incision 1.5 1,3,5 minutes after skin incision 1.6 before sternotomy 1.7 1,3,5 minutes after sternotomy; 2. Blood pressure (SBP, DBP,MAP)in mmHg 2.1 just after loading dose 2.2 before intubation 2.3 1,3,5 minutes after intubation 2.4 before skin incision 2.5 1,3,5 minute after skin incision 2.6 before sternotomy 2.7 1,3,5 minutes after sternotomy

Secondary Outcome Measures

Name	Time	Method
dose nicardipine	pre- aortic cannulation period , during surgery	dose nicardipine in milligrams to control systolic blood pressure 80-90 mmHg at aortic cannulation period

Trial Locations

Locations (1)

Sawanpracharak Hospital; 🇹🇭 Nakhon Sawan, Nakhonsawan, Thailand