Hemodynamic InstabilityNCT05218161
Hemodynamic Effect of Dexmedetomidine Alone With Dexmedetomidine Plus Ketamine Combination in CABG
A study testing Dexmedetomidine alone in people with Hemodynamic Instability, run by Chaudhry Pervaiz Elahi Institute of Cardiology at 1 site in Pakistan.
Trial summary
In post cardiac surgery, many cardiovascular and other complications may occur that lead to increase in mortality and hospital stays. Meticulous perioperative management is important to avoid these adverse events. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- Dexmedetomidine alone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2021to 1 Mar 2022
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of 40-60 years old Hemodynamically stable with normal or moderately impaired left ventricular function Ejection fraction >40% that underwent elective surgery CABG surgery for single vessel
Who cannot join
- Hemodynamic instability intraoperative. Patients on moderate to high vasopressors or ionotropes. Ejection fraction less than 40%. Off pump surgery. Patient on mechanical supports.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Hemodynamic Effect of Dexmedetomidine Alone With Dexmedetomidine Plus Ketamine Combination in Post Cardiac Surgery Patients: A Randomized Controlled Trial
In post cardiac surgery, many cardiovascular and other complications may occur that lead to increase in mortality and hospital stays. Meticulous perioperative management is important to avoid these adverse events. Tachycardia is the main cause of post coronary artery bypass graft (CABG) myocardial ischemia which can be decreased by sedation and analgesia.
Read the detailed description
Dexmedetomidine is a highly specific alpha 2 adrenoreceptor agonist. Its sedative effect results from stimulation of alpha 2 adrenoreceptors in the central nervous system (in the locus coeruleus) independent of GABA system contrary to other drugs.Dexmedetomidine has better sedative effect and similar respiratory and hemodynamic effects to midazolam. It does not depress respiratory drive or decrease arterial oxygen saturation so intravenous (IV) continuous sedation with dexmedetomidine does not change the normal course of ventilator weaning and extubation. It produces a unique EEG pattern of sleep that closely resembles that of normal physiological sleep that allows easy arousal. Dexmedetomidine also has analgesic effect. All these properties make dexmedetomidine a first line drug for the cooperative sedation management in the Intensive Care Unit (ICU). Ketamine is a phencyclidine nonbarbiturate derivative that binds with N methyl d aspartate and sigma opioid receptors to produce dissociative anesthesia, analgesia, and amnesia with little or no respiratory or cardiovascular depression. Ketamine inhibits endothelial nitric oxide production leading to positive inotropic action and vasoconstriction which preserves hemodynamic stability. Dexmedetomidine can effectively and safely attenuate the ketamine induced hemodynamic pressor response and psychomimetic effects. Dexmedetomidine expected to prevent the tachycardia, hypertension, salivation, and emergence phenomena associated with ketamine. Ketamine may prevent the bradycardia and hypotension that have been reported with dexmedetomidine. Review of literature has shown that there are very few studies present on the comparison of combination of Ketamine and dexmedetomidine with dexmedetomidine alone especially in post cardiac surgery patients and therefore further studies are required to ascertain the role of dexmedetomidine in terms of hemodynamic effects after cardiac surgery.
- Conditions
- Hemodynamic Instability
- Being tested
- Dexmedetomidine alone
- Keywords
- Cardiac Surgery, Dexmedetomidine, Extubation, Hemodynamics, Ketamine, Fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine aloneDrug
All the patients in group DA will be sedated using dexmedetomidine 1mcg/kg IV bolus, followed by 0.3-0.7mcg/kg/h infusion to maintain Ramsay sedation score ≥4 during assisted ventilation.
| Study group | Role | What they receive |
|---|---|---|
| DA | Active comparator | Group DA: will be assigned to patients in whom dexmedetomidine alone will be used. Receives: Drug: Dexmedetomidine alone |
| KD | Experimental | Group KD: will be assigned to patients receiving ketamine plus dexmedetomidine. Receives: Drug: Dexmedetomidine alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic stability
Hemodynamic stability:If blood pressure and heart rate are with in appropriate limits,it will be considered as hemodynamically stable.
Blood pressure:MAP>65 mmhg is considered stable. Heart rate:80-100 bpm is considered stable.
Measured: 06 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Jan 2021
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chaudhry Pervaiz Elahi Institute of Cardiology
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shumaila rai, Chaudhry Pervaiz Elahi Institute of Cardiology
- Investigators
- Dr Shumaila Rai, FCPS, Principal investigator, Chaudhry Pervaiz Elahi Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218161
- Sponsor's protocol ID
- CPEIC No. 153
- Other IDs
- 153
- Status last verified
- Jan 2022
- First submitted
- 18 Jan 2022
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Hemodynamic Effect of Dexmedetomidine Alone With Dexmedetomidine Plus Ketamine Combination in Post Cardiac Surgery Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05218161
- Acronym / sponsor ID
- CPEIC No. 153
- Conditions
- Hemodynamic Instability
- Keywords
- Cardiac Surgery, Dexmedetomidine, Extubation, Hemodynamics, Ketamine, Fentanyl
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chaudhry Pervaiz Elahi Institute of CardiologyOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 1 Feb 2022 (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.
In post cardiac surgery, many cardiovascular and other complications may occur that lead to increase in mortality and hospital stays. Meticulous perioperative management is important to avoid these adverse events. Tachycardia is the main cause of post coronary artery bypass graft (CABG) myocardial ischemia which can be decreased by sedation and analgesia.
Detailed description
Dexmedetomidine is a highly specific alpha 2 adrenoreceptor agonist. Its sedative effect results from stimulation of alpha 2 adrenoreceptors in the central nervous system (in the locus coeruleus) independent of GABA system contrary to other drugs.Dexmedetomidine has better sedative effect and similar respiratory and hemodynamic effects to midazolam. It does not depress respiratory drive or decrease arterial oxygen saturation so intravenous (IV) continuous sedation with dexmedetomidine does not change the normal course of ventilator weaning and extubation. It produces a unique EEG pattern of sleep that closely resembles that of normal physiological sleep that allows easy arousal. Dexmedetomidine also has analgesic effect. All these properties make dexmedetomidine a first line drug for the cooperative sedation management in the Intensive Care Unit (ICU). Ketamine is a phencyclidine nonbarbiturate derivative that binds with N methyl d aspartate and sigma opioid receptors to produce dissociative anesthesia, analgesia, and amnesia with little or no respiratory or cardiovascular depression. Ketamine inhibits endothelial nitric oxide production leading to positive inotropic action and vasoconstriction which preserves hemodynamic stability. Dexmedetomidine can effectively and safely attenuate the ketamine induced hemodynamic pressor response and psychomimetic effects. Dexmedetomidine expected to prevent the tachycardia, hypertension, salivation, and emergence phenomena associated with ketamine. Ketamine may prevent the bradycardia and hypotension that have been reported with dexmedetomidine. Review of literature has shown that there are very few studies present on the comparison of combination of Ketamine and dexmedetomidine with dexmedetomidine alone especially in post cardiac surgery patients and therefore further studies are required to ascertain the role of dexmedetomidine in terms of hemodynamic effects after cardiac surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA | Active comparator | Drug: Dexmedetomidine aloneGroup DA: will be assigned to patients in whom dexmedetomidine alone will be used. |
| KD | Experimental | Drug: Dexmedetomidine aloneGroup KD: will be assigned to patients receiving ketamine plus dexmedetomidine. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients of 40-60 years old Hemodynamically stable with normal or moderately impaired left ventricular function Ejection fraction >40% that underwent elective surgery CABG surgery for single vessel
Key exclusion criteria (1 listed)
- Hemodynamic instability intraoperative. Patients on moderate to high vasopressors or ionotropes. Ejection fraction less than 40%. Off pump surgery. Patient on mechanical supports.
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 |
|---|---|---|
| Dexmedetomidine aloneAll the patients in group DA will be sedated using dexmedetomidine 1mcg/kg IV bolus, followed by 0.3-0.7mcg/kg/h infusion to maintain Ramsay sedation score ≥4 during assisted ventilation. | Drug | DA, KD |
Primary outcome
Hemodynamic stability
Time frame: 06 months
Hemodynamic stability:If blood pressure and heart rate are with in appropriate limits,it will be considered as hemodynamically stable. Blood pressure:MAP>65 mmhg is considered stable. Heart rate:80-100 bpm is considered stable.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Dr Shumaila Rai, FCPS principal investigator
Chaudhry Pervaiz Elahi Institute of Cardiology
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 alone in people with Hemodynamic Instability, run by Chaudhry Pervaiz Elahi Institute of Cardiology at 1 site in Pakistan.
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 1 inclusion and 1 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 1 Feb 2022. 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 Pakistan. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic stability (time frame: 06 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2022.