Back to resultsIntravenous Esketamine on Prevention of Postoperative Depression in Patients Undergoing Cardiac Surgery
Primary Purpose
Postoperative Depression
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Esketamine
Normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Depression focused on measuring esketamine, postoperative depression, cardic surgey
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 7:Patients can not cooperate with investigators on psychiatric assessments
- 8:Pregnant or breastfeeding woman
- 9:refuse to sign informed consent.
Sites / Locations
- Beijing Chaoyang Hospital, Capital Medical UniversityRecruiting
- Beijing Chaoyang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Eskatamine group
Placebo group
Arm Description
Low-dose esketamine (0.3 mg/kg in 100 ml normal saline) is intravenously infused in 40 minutes before anesthesia induction
Placebo (40 ml normal saline) is intravenously infused in 40 minutes before anesthesia induction.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Postoperative delirium
Postoperative delirium will be assessed by the Confusion Assessment Method for the Intensive Care Unit Scale (CAM-ICU)
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.
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.
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.
Postoperative complications include psychiatric symptoms evaluated by Brief Psychiatric Rating Scale (BPRS)
Postoperative complications
Psychiatric manic symptoms assessed through the 11-item Young Mania Rating Scale (YMRS)
Psychiatric dissociative symptoms measured by the Clinician-Administered Dissociative States Scale (CADSS).
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05155969
Brief Title
Intravenous Esketamine on Prevention of Postoperative Depression in Patients Undergoing Cardiac Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 5, 2021 (Actual)
Study Completion Date
December 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anshi Wu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Depression
Keywords
esketamine, postoperative depression, cardic surgey
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Eskatamine group
Arm Type
Experimental
Arm Description
Low-dose esketamine (0.3 mg/kg in 100 ml normal saline) is intravenously infused in 40 minutes before anesthesia induction
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo (40 ml normal saline) is intravenously infused in 40 minutes before anesthesia induction.
Intervention Type
Drug
Intervention Name(s)
Esketamine
Other Intervention Name(s)
Ketamine hydrochloride
Intervention Description
esketamine (0.3 mg/kg in 100 ml normal saline) is intravenously infused 40 minutes before anesthesia induction
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Response rate
Description
≥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
Time Frame
Postoperative 5 Days
Secondary Outcome Measure Information:
Title
Anxiety symptom
Description
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.
Time Frame
Postoperative 5 days
Title
Postoperative delirium
Description
Postoperative delirium will be assessed by the Confusion Assessment Method for the Intensive Care Unit Scale (CAM-ICU)
Time Frame
1-7days after surgery, on the 30th day after surgery
Title
Postoperative insomnia
Description
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.
Time Frame
Postoperative 5 days
Title
Severe pain
Description
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.
Time Frame
Postoperative 3 days.
Title
Postoperative 30-day quality of life reported by SF-36
Description
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.
Time Frame
postoperative 30 days
Title
Postoperative complications include psychiatric symptoms evaluated by Brief Psychiatric Rating Scale (BPRS)
Description
Postoperative complications
Time Frame
Postoperative 5 days
Title
Psychiatric manic symptoms assessed through the 11-item Young Mania Rating Scale (YMRS)
Time Frame
Postoperative 5 days
Title
Psychiatric dissociative symptoms measured by the Clinician-Administered Dissociative States Scale (CADSS).
Time Frame
Postoperative 5 days
Title
Postoperative pain
Description
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
Time Frame
Postoperative 2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
7:Patients can not cooperate with investigators on psychiatric assessments
8:Pregnant or breastfeeding woman
9:refuse to sign informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anshi Wu Wu, Ph.D
Phone
+861085351330
Ext
Wu
Email
wuanshi1965@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anshi Wu Wu, Ph.D
Organizational Affiliation
Beijing Chao-Yang Hospital, Capital Medical Unive
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Chaoyang Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anshi Wu, MD
Phone
+8685231330
Email
wuanshi1965@163.com
First Name & Middle Initial & Last Name & Degree
Anshi Wu, MD
Facility Name
Beijing Chaoyang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anshi Wu, Ph.D
Phone
+861085351330
Ext
Wu anshi
Email
wuanshi1965@163.com
12. IPD Sharing Statement
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Intravenous Esketamine on Prevention of Postoperative Depression in Patients Undergoing Cardiac Surgery
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