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

CABG Clinical Trial

— CABG  

Official title:

Effect of Dexmedetomidine on Attenuation Hemodynamic Response in Coronary Artery Bypass Graft Surgical Patients: A Randomized Double Blind Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06238011
• Other study ID #: padetboonmark
• Secondary ID: sawanpracharakho
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 28, 2024
• Est. completion date: May 10, 2024

Study information

• Verified date: February 2024
• Source: Sawanpracharak hospital
• Contact: Padet Boonmark, MD
• Phone: +66819927577
• Email: padet2009[@]live.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 10, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• CABG

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine(Precedex Pfizer) prepared in concentration 0.1 mcg/kg/ml total volume50 ml by nurse anesthetist at preprocedure room, start dexmedetomidine by anesthesiologist at operating room loading 60 ml/hour for 10 minutes before induction of anesthesia then 5ml/hour until the patient on cardiopulmonary bypass (loading 1mcg/kg in 10 minutes then 0.5 mcg/kg/hour). Record patients data by nurse anesthetist
• Normal saline
Normal Saline total volume50 ml prepared by nurse anesthetist at preprocedure room, start Normal Saline by anesthesiologist at operating room loading 60 ml/hour for 10 minutes before induction of anesthesia then 5ml/hour until the patient on cardiopulmonary bypass. Record patients data by nurse anesthetist

Locations

Country	Name	City	State
Thailand	Sawanpracharak Hospital	Nakhon Sawan	Nakhonsawan

Sponsors (1)

Lead Sponsor	Collaborator
Sawanpracharak hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Poon WH, Ling RR, Yang IX, Luo H, Kofidis T, MacLaren G, Tham C, Teoh KLK, Ramanathan K. Dexmedetomidine for adult cardiac surgery: a systematic review, meta-analysis and trial sequential analysis. Anaesthesia. 2023 Mar;78(3):371-380. doi: 10.1111/anae.15947. Epub 2022 Dec 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	heart rate, blood pressure(systolic blood pressure, diastolic blood pressure, mean blood pressure)	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; 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	during surgery
Secondary	dose nicardipine	dose nicardipine in milligrams to control systolic blood pressure 80-90 mmHg at aortic cannulation period	pre- aortic cannulation period , during surgery