Randomized Controlled TrialPhase 4NCT06551259
Effect of Dexmedetomidine on Central Nervous System Complications in Patients Undergoing Cardiac Surgery
A Phase 4 study testing Dexmedetomidine and physiological saline in people with Randomized Controlled Trial and Dexmedetomidine, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
With the continuous improvement of medical technology, more and more patients need to undergo surgery as a kind of treatment for their diseases. However, there are various pains that may occur in the perioperative period, risks associated with anesthesia, loss of body organs, surgical trauma, and postoperative… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Randomized Controlled Trial, Dexmedetomidine
- What is being tested?
- Dexmedetomidine and physiological saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Aug 2024
- Phase
- Phase 4
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range from 18 to 85 years old, regardless of gender
- Patients who undergo cardiac surgery on a scheduled basis;
- ASA level 1-4;
- Obtain written informed consent form;
Who cannot join
- Patients with MMSE scores less than 18 or dementia, intellectual disability, and inability to communicate (coma, severe dementia, hearing or language impairment);
- Have a history of mental or neurological disorders (such as schizophrenia, epilepsy, Parkinson's disease, or severe myasthenia gravis);
- Previous history of brain injury;
- Severe liver dysfunction (Child pugh C-grade) or renal insufficiency (preoperative dialysis);
- Severe bradycardia (heart rate below 50 beats per minute), pathological sinus syndrome, or atrioventricular block without a pacemaker;
- Postoperative intensive care unit (ICU) duration exceeding 7 days or death;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intraoperative Dextrometomidine on Complications of the Central Nervous System in Patients Undergoing Cardiac Surgery: a Randomized Controlled Trial
With the continuous improvement of medical technology, more and more patients need to undergo surgery as a kind of treatment for their diseases. However, there are various pains that may occur in the perioperative period, risks associated with anesthesia, loss of body organs, surgical trauma, and postoperative procedures Factors such as the onset of the disease can cause the vast majority of patients to have varying degrees of emotional reactions such as worry, worry, nervousness, and fear. Emotional disorders such as depressed mood, disappointed crying, decreased mobility, and delayed thinking and cognitive function, that is, postoperative psychiatric symptoms.
Dexmedetomidine (DEX) is an alpha-2 adrenergic agonist that works by inhibiting norepinephrine. Releasing renaline, which reduces inflammation and thus plays a protective role in the central nervous system. Previous studies have shown that dexmedetomidine is lowering. DEX has the potential to prevent and treat patients undergoing cardiac surgery. The role of postoperative anxiety and depression needs to be further explored for evidence-based evidence. Based on the above research background, the hypothesis of this study is proposed. The intraoperative use of dexmedetomidine has a positive effect on alleviating postoperative anxiety and depression in patients undergoing postoperative cardiac surgery.
Read the detailed description
- Observing the effect of intraoperative use of dexmedetomidine on the incidence of postoperative anxiety and depression in patients undergoing cardiac surgery;
- Observe the effects of intraoperative use of dexmedetomidine on postoperative delirium, quality of life, pain scores, and sleep quality in patients undergoing cardiac surgery;
- To provide a feasible plan for preventing and treating postoperative anxiety and depression in patients undergoing cardiac surgery, improve the quality of patient prognosis, and reduce the burden on society.
- Conditions
- Randomized Controlled Trial, Dexmedetomidine
- Being tested
- Dexmedetomidine, physiological saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Intravenous infusion of 0.6μg/kg load dose of dexmedetomidine within 10 minutes after intubation, followed by continuous infusion at a rate of 0.4 μg/kg/h until 30 minutes before the end of surgery
physiological salineDrug
physiological saline
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: dexmedetomidine | Experimental | Intravenous infusion of 0.6μg/kg load dose of dexmedetomidine within 10 minutes after intubation, followed by continuous infusion at a rate of 0.4 μg/kg/h until 30 minutes before the end of surgery Receives: Drug: Dexmedetomidine |
| Control group | Placebo comparator | Provide equal volume of physiological saline Receives: Drug: physiological saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative depression
Patient Health Questionnaire-9 (PHQ-9) scale assesses depressive symptoms
Measured: Postoperative 7 days and 30 days
Secondary outcomes (7)
The incidence of postoperative anxiety
Generalized Anxiety Disorder-7 (GAD-7) Scale to Assess Anxiety Symptoms
Measured: Postoperative 7 days and 30 days
The incidence of postoperative delirium
Patients in the 3-Minute Diagnostic Interview for CAM (3D-CAM) general ward are evaluated by 3D-CAM. Delirium consists of four main features: acute altered mental status or fluctuating levels of consciousness, difficulty concentrating, confusion, and altered levels of consciousness. If both the first and second features are present, and the third or fourth feature is present, the patient is diagnosed with postoperative delirium.
Measured: Postoperative 7 days
Postoperative Pain
NRS Pain Scoring Criteria (0-10): NRS is 0-10, with 0 indicating no pain and 10 indicating the worst pain. The total amount of analgesic drug consumption and the number of PCIA active compressions within 48 hours were recorded every day
Measured: Postoperative 7 days and 30 days
Postoperative quality of life evaluation
Five-dimensional health scale EQ-5D, the five-dimensional health scale consists of 5 dimensions: mobility, self-care, activities of daily living, pain or discomfort, anxiety or depression. Each dimension contains three levels: no difficulty, some difficulty, and extreme difficulty. Through the conversion of effect size, the respondents can make choices at the five dimensions and three levels in the questionnaire, and calculate the score of the five-dimensional health scale index.
Measured: Postoperative 30 days
Postoperative mortality rate
Follow-up by phone or mail for patient mortality.
Measured: Postoperative 7 days and 30 days
Surgical related complications
Surgery-related complications include cardiovascular, respiratory, pulmonary, digestive, urinary, neurological, infection, pain, and bleeding from the surgery.
Measured: Postoperative 7 days
Postoperative sleep quality
Postoperative sleep quality was measured using the Pittsburgh Sleep Quality Index scale.
Measured: Postoperative 7 days and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Jan 2024
- Primary completion30 Jul 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Randomized Controlled TrialStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weidong Mi, Chinese PLA General Hospital
- Investigators
- WEIDONG MI, PhD, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551259
- Sponsor's protocol ID
- PLAGH-DEX-RCT-01
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 4 Sep 2024
- 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 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Dextrometomidine on Complications of the Central Nervous System in Patients Undergoing Cardiac Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06551259
- Acronym / sponsor ID
- PLAGH-DEX-RCT-01
- Conditions
- Randomized Controlled Trial, Dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 13 Aug 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.
With the continuous improvement of medical technology, more and more patients need to undergo surgery as a kind of treatment for their diseases. However, there are various pains that may occur in the perioperative period, risks associated with anesthesia, loss of body organs, surgical trauma, and postoperative procedures Factors such as the onset of the disease can cause the vast majority of patients to have varying degrees of emotional reactions such as worry, worry, nervousness, and fear. Emotional disorders such as depressed mood, disappointed crying, decreased mobility, and delayed thinking and cognitive function, that is, postoperative psychiatric symptoms.
Dexmedetomidine (DEX) is an alpha-2 adrenergic agonist that works by inhibiting norepinephrine. Releasing renaline, which reduces inflammation and thus plays a protective role in the central nervous system. Previous studies have shown that dexmedetomidine is lowering. DEX has the potential to prevent and treat patients undergoing cardiac surgery. The role of postoperative anxiety and depression needs to be further explored for evidence-based evidence. Based on the above research background, the hypothesis of this study is proposed. The intraoperative use of dexmedetomidine has a positive effect on alleviating postoperative anxiety and depression in patients undergoing postoperative cardiac surgery.
Detailed description
- Observing the effect of intraoperative use of dexmedetomidine on the incidence of postoperative anxiety and depression in patients undergoing cardiac surgery;
- Observe the effects of intraoperative use of dexmedetomidine on postoperative delirium, quality of life, pain scores, and sleep quality in patients undergoing cardiac surgery;
- To provide a feasible plan for preventing and treating postoperative anxiety and depression in patients undergoing cardiac surgery, improve the quality of patient prognosis, and reduce the burden on society.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group: dexmedetomidine | Experimental | Drug: DexmedetomidineIntravenous infusion of 0.6μg/kg load dose of dexmedetomidine within 10 minutes after intubation, followed by continuous infusion at a rate of 0.4 μg/kg/h until 30 minutes before the end of surgery |
| Control group | Placebo comparator | Drug: physiological salineProvide equal volume of physiological saline |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age range from 18 to 85 years old, regardless of gender
- Patients who undergo cardiac surgery on a scheduled basis;
- ASA level 1-4;
- Obtain written informed consent form;
Key exclusion criteria (6 listed)
- Patients with MMSE scores less than 18 or dementia, intellectual disability, and inability to communicate (coma, severe dementia, hearing or language impairment);
- Have a history of mental or neurological disorders (such as schizophrenia, epilepsy, Parkinson's disease, or severe myasthenia gravis);
- Previous history of brain injury;
- Severe liver dysfunction (Child pugh C-grade) or renal insufficiency (preoperative dialysis);
- Severe bradycardia (heart rate below 50 beats per minute), pathological sinus syndrome, or atrioventricular block without a pacemaker;
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 |
|---|---|---|
| DexmedetomidineIntravenous infusion of 0.6μg/kg load dose of dexmedetomidine within 10 minutes after intubation, followed by continuous infusion at a rate of 0.4 μg/kg/h until 30 minutes before the end of surgery | Drug | Intervention group: dexmedetomidine |
| physiological salinephysiological saline | Drug | Control group |
Primary outcome
The incidence of postoperative depression
Time frame: Postoperative 7 days and 30 days
Patient Health Questionnaire-9 (PHQ-9) scale assesses depressive symptoms
7 secondary outcomes
The incidence of postoperative anxiety
Time frame: Postoperative 7 days and 30 days
The incidence of postoperative delirium
Time frame: Postoperative 7 days
Postoperative Pain
Time frame: Postoperative 7 days and 30 days
Postoperative quality of life evaluation
Time frame: Postoperative 30 days
Postoperative mortality rate
Time frame: Postoperative 7 days and 30 days
Surgical related complications
Time frame: Postoperative 7 days
Postoperative sleep quality
Time frame: Postoperative 7 days and 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Randomized Controlled Trial
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
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.
WEIDONG MI, PhD study chair
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and physiological saline in people with Randomized Controlled Trial and Dexmedetomidine, run by Chinese PLA General Hospital at 1 site in China.
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 4 inclusion and 6 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 4 Sep 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 China. 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The incidence of postoperative depression (time frame: Postoperative 7 days and 30 days). 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 4 Sep 2024.