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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04425473
Other study ID # Z191100006619067
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date February 19, 2021
Est. completion date December 31, 2023

Study information

Verified date March 2023
Source Beijing Tiantan Hospital
Contact Ruquan Han, M.D., Ph D.
Phone 8610-59976660
Email ruquan.han@ccmu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Perioperative depressive symptoms (PDS) are common in population undergoing surgery, and this would be sharpened especially for complicated, high-risk major surgery. However, None of treatments could resolve this clinical problem during limited perioperative period. The remarkable effects of ketamine on treatment resistant depression have been verified by several clinical trials and the enantiomer S-ketamine (esketamine) showed similar antidepressant efficacy with better safety in recent studies. The efficacy and safety of esketamine administrated intra-operatively for PDS will be verified in this study. Other secondary outcomes such as anxiety, postoperative pain and psychiatric symptoms will also be investigated.


Recruitment information / eligibility

Status Recruiting
Enrollment 564
Est. completion date December 31, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Patient undergoing elective major surgery - Ages between 18 and 65 years old - Moderate to severe depressive symptoms ( the Patient Health Questionnaire-9 scores equal to or more than 10 and Montgomery-Åsberg Depression Rating Scale scores equal to or more than 22 ) - Signed informed consent Exclusion Criteria: - Patients combined with aphasia or other conditions leads that patients inability to cooperate with the metal assessments; - Tumor related injury of the 9th, 10th, 11th, 12th cranial nerve or patients need keeping intubation after surgery; - Medical history of psychotic or bipolar disorder; - Laboratory evidence of hormone levels disorder due to primary diseases; - Body Mass Index more than 30 kg/?; - Child-Pugh grade B or C; - Major depressive disorder with antidepressant therapy in the past 2 weeks before screening; - History of adverse events to ketamine or esketamine; - Patients with repeated suicide attempts (QIDS-SR 12-item more than or equal to 3); - History of drug abused; - Pregnant or breastfeeding woman.

Study Design


Intervention

Drug:
Esketamine
Esketamine will be administrated intravenously when suturing incision, with total dose of 0.2mg/kg and continuous infusion for 40 minutes.
Normal saline
Equivalent amount of normal saline will be administrated intravenously suturing incision.

Locations

Country Name City State
China Beijing Tiantan Hospital, Capital Medical University Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Depressive symptoms remission Remission is defined as MADRS total score no more than 10 Postoperative 3-day
Secondary MADRS scores The differences in MADRS scores Postoperative 3-day
Secondary Depressive symptoms response The rates of patients achieving a response Postoperative 3-day
Secondary Severe pain The rate of severe pain after surgery postoperative 3-day
Secondary Side-effects and Adverse events All drug-related adverse events during surgery or before discharge During surgery or up to 7 days after surgery
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