Postoperative DepressionNCT05155969
Intravenous Esketamine on Prevention of Postoperative Depression in Patients Undergoing Cardiac Surgery
A study testing Esketamine and Normal saline in people with Postoperative Depression, run by Anshi Wu at 2 sites in China.
Trial summary
Esketamine is a general anesthetic with anti-depressant effects at subanaesthetic doses. This study hypothesized that intraoperative administration of ketamine would prevent or mitigate postoperative depressive symptoms in surgical patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Depression
- What is being tested?
- Esketamine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesChina
- Study dates
- 1 Dec 2021to 15 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1:Patients scheduled for heart surgery
- 2:Moderate to severe depressive symptom measured by the qualified psychiatric doctors
- 3:Over 18 years of age
- 4:American Society of Anesthesiologists physical status I-III
Who cannot join
- 1:History of epilepsy
- 2:Major depression disorder patients undergoing antidepressive therapy within 2 weeks
- 3: Psychiatric illness
- 4: Drug abuse
- 5:History of allergy to esketamine
- 6:Hyperthyroidism
Show all 9Show fewer
- 7:Patients can not cooperate with investigators on psychiatric assessments
- 8:Pregnant or breastfeeding woman
- 9:refuse to sign informed consent.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
Anshi Wu, MD, +8685231330, wuanshi1965@163.com
Anshi Wu, MD
- Recruiting
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100020
Anshi Wu, Ph.D, +861085351330 ext. Wu anshi, wuanshi1965@163.com
About this study
Official title: Evaluating the Effect of Subanaesthetic Dose of Esketamine on Prevention of Postoperative Depression in Patients Undergoing Cardiac Surgery：a Randomized, Double-blind, Placebo-controlled Pilot and Feasibility Trial
Esketamine is a general anesthetic with anti-depressant effects at subanaesthetic doses. This study hypothesized that intraoperative administration of ketamine would prevent or mitigate postoperative depressive symptoms in surgical patients.
Read the detailed description
Single subanaesthetic doses of i.v. esketamine may significantly improve symptoms in psychiatric patients with major depression.
In patients undergoing cardiac surgery, postoperative depressive symptoms are common.
This study hypothesizes that low-dose esketamine has a preventive effect on postoperative depression. However, evidence in this aspect is insufficient. The purpose of this study is to investigate the effect of a subanaesthetic dose of ketamine on POD for patients undergoing cardiac surgery.
- Conditions
- Postoperative Depression
- Being tested
- Esketamine, Normal saline
- Keywords
- esketamine, postoperative depression, cardic surgey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
Also called Ketamine hydrochloride
esketamine (0.3 mg/kg in 100 ml normal saline) is intravenously infused 40 minutes before anesthesia induction
Normal salineDrug
Also called saline
Normal saline will be administrated intravenously at the dural opening, with a total dose of 0.5 ml/kg and continual infusion for 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Eskatamine group | Experimental | Low-dose esketamine (0.3 mg/kg in 100 ml normal saline) is intravenously infused in 40 minutes before anesthesia induction Receives: Drug: Esketamine |
| Placebo group | Placebo comparator | Placebo (40 ml normal saline) is intravenously infused in 40 minutes before anesthesia induction. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
≥50% reduction in MADRS scores from the baseline value. The MADRS is a 10-item tool, with scores ranging from 0 to 60, and determining the severity of depression
Measured: Postoperative 5 Days
Secondary outcomes (9)
Anxiety symptom
The anxious symptom is defined as a GAD-7 score no less than 10. The GAD-7 is a 7-item tool, with scores ranging from 0 to 21, The higher the score, the worse the anxiety.
Measured: Postoperative 5 days
Postoperative delirium
Postoperative delirium will be assessed by the Confusion Assessment Method for the Intensive Care Unit Scale (CAM-ICU)
Measured: 1-7days after surgery, on the 30th day after surgery
Postoperative insomnia
Postoperative insomnia is defined as an ISI score of no less than 15. ISI is a 7-item tool, with scores ranging from 0 to 28, The higher the score, the worse insomnia.
Measured: Postoperative 5 days
Severe pain
The incidence of severe pain within first postoperative three days, which is defined as mean and peak numerical rating scale (NRS) are higher than 5.
Measured: Postoperative 3 days.
Postoperative 30-day quality of life reported by SF-36
The quality of life will be evaluated by the 36-Item Short-Form Health Survey, SF-36 at postoperative 30 days SF-36 is a 36-item tool, with scores ranging from 1 to 100, The higher the score, the better the quality of life.
Measured: postoperative 30 days
Postoperative complications include psychiatric symptoms evaluated by Brief Psychiatric Rating Scale (BPRS)
Postoperative complications
Measured: Postoperative 5 days
Psychiatric manic symptoms assessed through the 11-item Young Mania Rating Scale (YMRS)
Measured: Postoperative 5 days
Psychiatric dissociative symptoms measured by the Clinician-Administered Dissociative States Scale (CADSS).
Measured: Postoperative 5 days
Postoperative pain
The postoperative pain will be evaluated by Numerical pain scale（NRS） NRS is a tool with scores ranging from 1 to 10, the higher the score, the more intense the pain
Measured: Postoperative 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start1 Dec 2021
- Primary completion5 Dec 2021
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DepressionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anshi Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anshi Wu, Beijing Chao Yang Hospital
- Investigators
- Anshi Wu Wu, Ph.D, Study chair, Beijing Chao-Yang Hospital, Capital Medical Unive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155969
- Sponsor's protocol ID
- 10110815
- Status last verified
- Dec 2021
- First submitted
- 8 Dec 2021
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Subanaesthetic Dose of Esketamine on Prevention of Postoperative Depression in Patients Undergoing Cardiac Surgery：a Randomized, Double-blind, Placebo-controlled Pilot and Feasibility Trial
- ClinicalTrials.gov ID
- NCT05155969
- Acronym / sponsor ID
- 10110815
- Conditions
- Postoperative Depression
- Keywords
- esketamine, postoperative depression, cardic surgey
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Anshi WuUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 5 Dec 2021 (actual)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 14 Dec 2021 (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.
Esketamine is a general anesthetic with anti-depressant effects at subanaesthetic doses. This study hypothesized that intraoperative administration of ketamine would prevent or mitigate postoperative depressive symptoms in surgical patients.
Detailed description
Single subanaesthetic doses of i.v. esketamine may significantly improve symptoms in psychiatric patients with major depression.
In patients undergoing cardiac surgery, postoperative depressive symptoms are common.
This study hypothesizes that low-dose esketamine has a preventive effect on postoperative depression. However, evidence in this aspect is insufficient. The purpose of this study is to investigate the effect of a subanaesthetic dose of ketamine on POD for patients undergoing cardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eskatamine group | Experimental | Drug: EsketamineLow-dose esketamine (0.3 mg/kg in 100 ml normal saline) is intravenously infused in 40 minutes before anesthesia induction |
| Placebo group | Placebo comparator | Drug: Normal salinePlacebo (40 ml normal saline) is intravenously infused in 40 minutes before anesthesia induction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1:Patients scheduled for heart surgery
- 2:Moderate to severe depressive symptom measured by the qualified psychiatric doctors
- 3:Over 18 years of age
- 4:American Society of Anesthesiologists physical status I-III
Key exclusion criteria (9 listed)
- 1:History of epilepsy
- 2:Major depression disorder patients undergoing antidepressive therapy within 2 weeks
- 3: Psychiatric illness
- 4: Drug abuse
- 5:History of allergy to esketamine
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 |
|---|---|---|
| EsketamineAlso: Ketamine hydrochlorideesketamine (0.3 mg/kg in 100 ml normal saline) is intravenously infused 40 minutes before anesthesia induction | Drug | Eskatamine group |
| Normal salineAlso: salineNormal saline will be administrated intravenously at the dural opening, with a total dose of 0.5 ml/kg and continual infusion for 40 minutes. | Drug | Placebo group |
Primary outcome
Response rate
Time frame: Postoperative 5 Days
≥50% reduction in MADRS scores from the baseline value. The MADRS is a 10-item tool, with scores ranging from 0 to 60, and determining the severity of depression
9 secondary outcomes
Anxiety symptom
Time frame: Postoperative 5 days
Postoperative delirium
Time frame: 1-7days after surgery, on the 30th day after surgery
Postoperative insomnia
Time frame: Postoperative 5 days
Severe pain
Time frame: Postoperative 3 days.
Postoperative 30-day quality of life reported by SF-36
Time frame: postoperative 30 days
Postoperative complications include psychiatric symptoms evaluated by Brief Psychiatric Rating Scale (BPRS)
Time frame: Postoperative 5 days
Psychiatric manic symptoms assessed through the 11-item Young Mania Rating Scale (YMRS)
Time frame: Postoperative 5 days
Psychiatric dissociative symptoms measured by the Clinician-Administered Dissociative States Scale (CADSS).
Time frame: Postoperative 5 days
Postoperative pain
Time frame: Postoperative 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
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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.
Anshi Wu Wu, Ph.D study chair
Beijing Chao-Yang Hospital, Capital Medical Unive
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esketamine and Normal saline in people with Postoperative Depression, run by Anshi Wu at 2 sites 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 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 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 Anshi Wu Wu, Ph.D (+861085351330 ext. Wu, wuanshi1965@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: Postoperative 5 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 14 Dec 2021.