Oxidative StressPhase 4NCT03054857
The Effect of Dexmedetomidine Infusion on Post-operative Cognitive Function and Oxidative Stress in Cardiac Surgery
A Phase 4 study testing Dexmedetomidine in people with Oxidative Stress and Cognition Disorders, run by Chulalongkorn University.
Trial summary
Objective: The aim of this study was to determine the effect of dexmedetomidine in reducing postoperative cognitive dysfunction (POCD) in cardiac surgical patients which use cardiopulmonary bypass machine (CPB). Materials and Methods: This study was double-blinded, randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Oxidative Stress, Cognition Disorders
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Dec 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I-III.
Who cannot join
- patients who were allergy to medication in the research regimen
- preoperative left ventricular ejection fraction less than 30%
- body mass index more than 35 kg/m2
- preoperative mean arterial pressure less than 60 mmHg
- preoperative heart rate less than 45/min
- patients with impaired renal function (serum creatinine more than 1.5 mg/dl in female and 2 mg/dl in male)
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- active liver disease, and who had history of symptomatic cerebrovascular disease
- psychiatric problem and other neurological diseases
- patients who cannot read
About this study
Official title: The Effect of Dexmedetomidine Infusion on Post-operative Cognitive Function and Oxidative Stress in Patients Undergo Cardiopulmonary Bypass Machine Facilitated Elective Cardiac Surgery
Objective: The aim of this study was to determine the effect of dexmedetomidine in reducing postoperative cognitive dysfunction (POCD) in cardiac surgical patients which use cardiopulmonary bypass machine (CPB).
Materials and Methods: This study was double-blinded, randomized controlled trial. Patients scheduled for elective CPB facilitated cardiac surgery were randomly assigned in two groups, dexmedetomidine group (DEX) or control group. The cognitive tests (MoCA test and Short bless test) were done before the operation, 48 hours, and 7 days postoperatively. POCD was defined as a decline of 1SD of baseline score in any test. Arterial blood sample were analyzed for IL-6, IL-10, TNF-alpha and hs-CRP before induction (T0), after separation from CPB (T1), arrival at ICU (T2) and 24-hour after surgery (T3). Primary outcome was the incidence of POCD and the secondary outcomes were inflammatory response, other postoperative complications, ICU and hospital stay.
Read the detailed description
After the patients were enrolled in the study, they were allocated into Dexmedetomidine group or control group by computer-based randomization. Patients, surgeons, anesthesiologists and researchers who performed the cognitive test were all blinded to the study groups.
General anesthesia was induced with intravenously midazolam 0.1-0.2 mg/kg and fentanyl 5-10 mcg/kg or Thiopental 3-5 mg/kg or Propofol 2 mg/kg. Patients were intubated with pancuronium 1 mg/kg or rocuronium 0.6-1 mg/kg. Anesthesia was maintained with nitrous oxide in oxygen, isoflurane, fentanyl, and pancuronium or rocuronium as required. Standard monitoring was provided including an indwelling radial artery catheter and central venous catheter. Bispectral index (BIS) monitoring was applied and maintained between 40-60 through the operation. Cerebral oximetry was monitored both sides of the brain by non-invasive oximeters at forehead area and the data were recorded.
After skin incision, the Dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation.The control group received a loading dose and continuous IV infusion of normal saline at the same rate.
During the cardiopulmonary bypass, mean arterial pressure was maintained at 60-80 mmHg or 20% from baseline. If hypertension was detected, Nicardipine 0.2 mg was given intravenously. Ephedrine 6 mg or norepinephrine 4 mcg were given within 5 minutes and repeated every 5 minutes if hypotension was presented. Atropine 0.6 mg was administered for bradycardia (heart rate less than 50 beats per minute). After the operation, patients were transferred to Cardio-thoracic intensive care unit and received standard postoperative cardiac surgery care.
2 neuropsychological tests were used to evaluate patients' cognitive function; Montreal Cognitive Assessment (MoCA) and Short blessed test (SBT). These tests were chosen by King Chulalongkorn Memorial Hospital's psychiatrist based on previous studies and the statement consensus on assessment of neurobehavioral outcomes after cardiac surgery published in 1995. All patients were evaluated their cognitive function for 3 points of time, 1st time was at preoperative period (T1), 2nd time was at 48 hours postoperatively (T2) and the last one was at 7 days postoperatively or the day at discharge from the hospital (T3). POCD was defined as a decline of 1 standard deviation (1SD) of baseline score in any test.
Blood samples were taken through the radial artery catheter, and sampling times were chosen as follows: before the induction of anaesthesia (T0); after separated from CPB (T1); arrival at intensive care unit (ICU) (T2); 24 hr after surgery (T3). Plasma Tissue Necrotic Factor-Alpha (TNF-α), Interleukin-6 (IL-6) and Interleukin-10 (IL-10) levels were measured by Magnetic Luminex Performance Assay. High sensitivity C-reactive protein (CRP) level were also measured by nephelometry.
- Conditions
- Oxidative Stress, Cognition Disorders
- Being tested
- Dexmedetomidine, Placebo
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dex
After skin incision, the dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation.
PlaceboDrug
The control group received a loading dose and continuous IV infusion of normal saline at the same volume and rate as in the dexmedetomidine group
| Study group | Role | What they receive |
|---|---|---|
| Dex group | Experimental | After skin incision, the Dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation. Receives: Drug: Dexmedetomidine |
| Placebo group | Placebo comparator | The control group received a loading dose and continuous IV infusion of normal saline at the same rate. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of Participants With Postoperative Cognitive Dysfunction (POCD)
POCD was defined as a decline of 1 standard-deviation (1SD) of baseline score in either MoCA test or short bless test.
Measured: 48 hours
Number of Participants With Postoperative Cognitive Dysfunction (POCD)
POCD was defined as a decline of 1SD of baseline score in either MoCA test or short bless test.
Measured: 7 days
Secondary outcomes (3)
Number of Participants With Postoperative Complications
Neurological complication, Delirium, dysrhythmia, death
Measured: 7 days
Hospital Stay in Days
Measured: 30 days
ICU Stay in Hours
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study startJun 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wirinda Chiravanich, MD, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054857
- Sponsor's protocol ID
- 2558-102
- Status last verified
- May 2018
- First submitted
- 1 Jun 2016
- Last updated
- 19 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine Infusion on Post-operative Cognitive Function and Oxidative Stress in Patients Undergo Cardiopulmonary Bypass Machine Facilitated Elective Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03054857
- Acronym / sponsor ID
- 2558-102
- Conditions
- Oxidative Stress, Cognition Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Posted 19 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: The aim of this study was to determine the effect of dexmedetomidine in reducing postoperative cognitive dysfunction (POCD) in cardiac surgical patients which use cardiopulmonary bypass machine (CPB).
Materials and Methods: This study was double-blinded, randomized controlled trial. Patients scheduled for elective CPB facilitated cardiac surgery were randomly assigned in two groups, dexmedetomidine group (DEX) or control group. The cognitive tests (MoCA test and Short bless test) were done before the operation, 48 hours, and 7 days postoperatively. POCD was defined as a decline of 1SD of baseline score in any test. Arterial blood sample were analyzed for IL-6, IL-10, TNF-alpha and hs-CRP before induction (T0), after separation from CPB (T1), arrival at ICU (T2) and 24-hour after surgery (T3). Primary outcome was the incidence of POCD and the secondary outcomes were inflammatory response, other postoperative complications, ICU and hospital stay.
Detailed description
After the patients were enrolled in the study, they were allocated into Dexmedetomidine group or control group by computer-based randomization. Patients, surgeons, anesthesiologists and researchers who performed the cognitive test were all blinded to the study groups.
General anesthesia was induced with intravenously midazolam 0.1-0.2 mg/kg and fentanyl 5-10 mcg/kg or Thiopental 3-5 mg/kg or Propofol 2 mg/kg. Patients were intubated with pancuronium 1 mg/kg or rocuronium 0.6-1 mg/kg. Anesthesia was maintained with nitrous oxide in oxygen, isoflurane, fentanyl, and pancuronium or rocuronium as required. Standard monitoring was provided including an indwelling radial artery catheter and central venous catheter. Bispectral index (BIS) monitoring was applied and maintained between 40-60 through the operation. Cerebral oximetry was monitored both sides of the brain by non-invasive oximeters at forehead area and the data were recorded.
After skin incision, the Dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation.The control group received a loading dose and continuous IV infusion of normal saline at the same rate.
During the cardiopulmonary bypass, mean arterial pressure was maintained at 60-80 mmHg or 20% from baseline. If hypertension was detected, Nicardipine 0.2 mg was given intravenously. Ephedrine 6 mg or norepinephrine 4 mcg were given within 5 minutes and repeated every 5 minutes if hypotension was presented. Atropine 0.6 mg was administered for bradycardia (heart rate less than 50 beats per minute). After the operation, patients were transferred to Cardio-thoracic intensive care unit and received standard postoperative cardiac surgery care.
2 neuropsychological tests were used to evaluate patients' cognitive function; Montreal Cognitive Assessment (MoCA) and Short blessed test (SBT). These tests were chosen by King Chulalongkorn Memorial Hospital's psychiatrist based on previous studies and the statement consensus on assessment of neurobehavioral outcomes after cardiac surgery published in 1995. All patients were evaluated their cognitive function for 3 points of time, 1st time was at preoperative period (T1), 2nd time was at 48 hours postoperatively (T2) and the last one was at 7 days postoperatively or the day at discharge from the hospital (T3). POCD was defined as a decline of 1 standard deviation (1SD) of baseline score in any test.
Blood samples were taken through the radial artery catheter, and sampling times were chosen as follows: before the induction of anaesthesia (T0); after separated from CPB (T1); arrival at intensive care unit (ICU) (T2); 24 hr after surgery (T3). Plasma Tissue Necrotic Factor-Alpha (TNF-α), Interleukin-6 (IL-6) and Interleukin-10 (IL-10) levels were measured by Magnetic Luminex Performance Assay. High sensitivity C-reactive protein (CRP) level were also measured by nephelometry.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dex group | Experimental | Drug: DexmedetomidineAfter skin incision, the Dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation. |
| Placebo group | Placebo comparator | Drug: PlaceboThe control group received a loading dose and continuous IV infusion of normal saline at the same rate. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status I-III.
Key exclusion criteria (9 listed)
- patients who were allergy to medication in the research regimen
- preoperative left ventricular ejection fraction less than 30%
- body mass index more than 35 kg/m2
- preoperative mean arterial pressure less than 60 mmHg
- preoperative heart rate less than 45/min
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: DexAfter skin incision, the dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation. | Drug | Dex group |
| PlaceboThe control group received a loading dose and continuous IV infusion of normal saline at the same volume and rate as in the dexmedetomidine group | Drug | Placebo group |
Primary outcome
Numbers of Participants With Postoperative Cognitive Dysfunction (POCD)
Time frame: 48 hours
POCD was defined as a decline of 1 standard-deviation (1SD) of baseline score in either MoCA test or short bless test.
Number of Participants With Postoperative Cognitive Dysfunction (POCD)
Time frame: 7 days
POCD was defined as a decline of 1SD of baseline score in either MoCA test or short bless test.
3 secondary outcomes
Number of Participants With Postoperative Complications
Time frame: 7 days
Hospital Stay in Days
Time frame: 30 days
ICU Stay in Hours
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine in people with Oxidative Stress and Cognition Disorders, run by Chulalongkorn University.
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 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: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Numbers of Participants With Postoperative Cognitive Dysfunction (POCD) (time frame: 48 hours). The study lists 2 primary outcomes in all. 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 19 Jun 2018.