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

NCT06238011 | Not Yet Recruiting DMC

• 2 other identifiers: padetboonmarksawanpracharakhospital
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

CABG

Keywords

dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• heart rate, blood pressure(systolic blood pressure, diastolic blood pressure, mean blood pressure)

  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

  during surgery

Secondary Outcomes (1)

• dose nicardipine

  pre- aortic cannulation period , during surgery

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

Patient in this arm will receive dexmedetomidine loading 60ml/hour before induction of anesthesia then 5ml/hour until the patient on cardiopulmonary bypass

Drug: Dexmedetomidine

Normal Saline

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

Dexmedetomidine DRUG

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

Also known as: Precedex

Dexmedetomidine

Normal saline DRUG

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

Normal Saline

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sawanpracharak hospital: lead

Study Sites (1)

Sawanpracharak Hospital

Nakhon Sawan, Nakhonsawan, 60000, Thailand

Location

Related 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.

  PMID: 36535747 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Padet Boonmark, MD

  Sawanpracharak hospital Thailand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Padet Boonmark, MD

CONTACT

+66819927577; padet2009@live.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician at Department of Anesthesiology

Model Details: 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

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 2, 2024
• Study Start: February 28, 2024
• Primary Completion: April 30, 2024
• Study Completion: May 10, 2024
• Last Updated: February 5, 2024

Record last verified: 2024-02

Locations

TH (1)