CABGCABGNCT06238011
Dexmedetomidine vs Control on Attenuation Hemodynamic Response to Noxious Stimuli in CABG Surgical Patients
A study testing Dexmedetomidine and Normal saline in people with CABG, run by Sawanpracharak hospital at 1 site in Thailand.
Trial summary
Aim to study efficacy of dexmedetomidine to attenuate hemodynamic response to intubation, skin incision, sternotomy and aortic cannulation Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- CABG
- What is being tested?
- Dexmedetomidine and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 28 Feb 2024to 10 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients schedule for CABG
- American Society of Anesthesiologist (ASA) class II-III
Who cannot join
- 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
Show all 9Show fewer
- severe pulmonary, renal, hepatic disease
- neurologic disease
- preoperative medication with methyldopa or clonidine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- CABG
- Being tested
- Dexmedetomidine, Normal saline
- Keywords
- dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
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 salineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during surgery
Secondary outcomes (1)
dose nicardipine
dose nicardipine in milligrams to control systolic blood pressure 80-90 mmHg at aortic cannulation period
Measured: pre- aortic cannulation period , during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start28 Feb 2024 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion10 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CABGStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sawanpracharak hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Padet Boonmark, Sawanpracharak hospital
- Investigators
- Padet Boonmark, MD, Principal investigator, Sawanpracharak hospital Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238011
- Sponsor's protocol ID
- padetboonmark
- Other IDs
- sawanpracharakhospital
- Acronym
- CABG
- Status last verified
- Feb 2024
- First submitted
- 15 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36535747
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine on Attenuation Hemodynamic Response in Coronary Artery Bypass Graft Surgical Patients: A Randomized Double Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT06238011
- Acronym / sponsor ID
- CABG / padetboonmark
- Conditions
- CABG
- Keywords
- dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sawanpracharak hospitalUniversity, hospital or other
- Study start
- 28 Feb 2024 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 10 May 2024 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: DexmedetomidinePatient in this arm will receive dexmedetomidine loading 60ml/hour before induction of anesthesia then 5ml/hour until the patient on cardiopulmonary bypass |
| Normal Saline | Placebo comparator | Drug: Normal salinePatient in this arm will receive normal saline loading 60ml/hour before induction of anesthesia then 5ml/hour until the patient on cardiopulmonary artery bypass |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients schedule for CABG
- American Society of Anesthesiologist (ASA) class II-III
Key exclusion criteria (9 listed)
- anticipated difficult intubation
- body mass index\> 30 kg/m2
- Ejection Fraction \< 40%
- left main coronary artery occlusion \>50%
- left bundle branch block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: PrecedexDexmedetomidine(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 | Drug | Dexmedetomidine |
| Normal salineNormal 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 | Drug | Normal Saline |
Primary outcome
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
1 secondary outcome
dose nicardipine
Time frame: pre- aortic cannulation period , during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Background: PubMed 36535747Poon 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.
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Coronary Artery Bypass Graft (CABG)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Padet Boonmark, MD principal investigator
Sawanpracharak hospital Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Normal saline in people with CABG, run by Sawanpracharak hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Padet Boonmark, MD (+66819927577, padet2009@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart rate, blood pressure(systolic blood pressure, diastolic blood pressure, mean blood pressure) (time frame: during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06238011, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.