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

February 1, 2024 updated by: Padet Boonmark, Sawanpracharak hospital

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
    • Nakhonsawan
      • Nakhon Sawan, Nakhonsawan, Thailand, 60000
        • Sawanpracharak Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexmedetomidine
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
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
Other Names:
  • Precedex
Placebo Comparator: 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
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rate, blood pressure(systolic blood pressure, diastolic blood pressure, mean blood pressure)
Time Frame: 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
during surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dose nicardipine
Time Frame: pre- aortic cannulation period , during surgery
dose nicardipine in milligrams to control systolic blood pressure 80-90 mmHg at aortic cannulation period
pre- aortic cannulation period , during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sawanpracharak hospital

Investigators

  • Principal Investigator: Padet Boonmark, MD, Sawanpracharak hospital Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 28, 2024

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

May 10, 2024

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria

January 24, 2024

First Posted (Actual)

February 2, 2024

Study Record Updates

Last Update Posted (Actual)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • padetboonmark
  • sawanpracharakhospital (Registry Identifier: PBoonmark)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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