Clinical trial NCT06238011: Dexmedetomidine vs Control on Attenuation Hemodynamic Response to Noxious Stimuli in CABG Surgical Patients
Official title: Effect of Dexmedetomidine on Attenuation Hemodynamic Response in Coronary Artery Bypass Graft Surgical Patients: A Randomized Double Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: CABG
Keywords: dexmedetomidine
Lead sponsor: Sawanpracharak hospital
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial was conduct between January2024 and March2024 at Sawanpracharak hospital, Thailand, Of 60 patients undergoing elective CABG surgery, 30 were assigned to group dexmedetomidine and 30 to group control. Dexmedetomidine prepared by nurse anesthetist in contraction 0.1mcg/kg/ml total volume 50 ml. Loading 60ml/hour in 10 minutes before induction of anesthesia then 5ml/hour until on cardiopulmonary bypass (1mcg/kg in 10 min then 0.5mcg/kg/hour). Group control received normal saline 60ml/hour in 10 minutes then 5ml/hour
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: heart rate, blood pressure(systolic blood pressure, diastolic blood pressure, mean blood pressure)
timeFrame: during surgery
Secondary outcomes:
measure: dose nicardipine
timeFrame: pre- aortic cannulation period , during surgery
Other outcomes:
Locations:
city: Nakhon Sawan
country: Thailand
facility: Sawanpracharak Hospital
state: Nakhonsawan
Study officials:
affiliation: Sawanpracharak hospital Thailand
name: Padet Boonmark, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.