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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05506787
Other study ID # 2020NZKY-062-01
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 1, 2020
Est. completion date March 1, 2022

Study information

Verified date April 2023
Source Jinling Hospital Affiliated to c University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Crohn's disease (CD) is a chronic inflammatory disease of the gastrointestinal tract with symptoms evolving in a relapsing and remitting manner. Typically, the peak incidence of CD is 18 to 35 years , which means that patients with CD will be plagued by the disease during their most precious years, and nearly 35% of them will develop depressive symptoms. For 70% of patients with CD who need surgery, the incidence of preoperative depression may be higher. The CD cohort with diagnosable psychological condition has been shown to experience a higher rate of disease exacerbation than the CD cohort without psycho complication. At the same time, this depressive mood may make postoperative recovery more difficult, so it is necessary to alleviate postoperative depression. Ketamine, a widely used anesthetic, is also used to treat depression. The most used ketamine in clinical practice is racemic ketamine, but its use is associated with many complications such as psychotic adverse effects and neurotoxicity. In recent years, S-ketamine has received attention for better efficacy and fewer complications . In 2019, the Food and Drug Administration (FDA) approved S-ketamine nasal spray for the treatment of refractory depression and subsequently received approval from numerous health authorities around the world. This proves that S-ketamine can provide a rapid antidepressant effect in patients with depression in a non-surgical setting. However, it is inconclusive whether S-ketamine affects surgical patients, mainly because of differences in the type of surgery, the dosage administered, the interaction with analgesics, and the evaluation tools implemented. Studies have shown that small doses of S-ketamine in breast cancer surgery and cervical cancer surgery can reduce postoperative depression. However, the effects of S-ketamine on postoperative depression (POD) and pain in patients with CD have not been studied.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date March 1, 2022
Est. primary completion date February 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: 1. subjects who volunteered and signed informed consent for the trial, (b) patients aged between 18 and 60, (c) patients with CD who underwent surgery, (d) American Society of Anesthesiologists (ASA) grade ?~?, (e) Hamilton depression score 8-24. Exclusion Criteria: 1. allergy to narcotic drugs or ketamine used, (b) patients with other serious systemic diseases (including severe heart, kidney, and liver disease), (c) chronic opioid therapy (more than twice a week for more than three months), (d) inability to understand the digital pain scale, (e) Hamilton depression score < 8 or > 24.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Esketamine
Esketamine
Placebo
Placebo

Locations

Country Name City State
China Anesthesiology Department, Jinling Hospital Affiliated to Nanjing University Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Jinling Hospital Affiliated to c University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the HAMD-17 score on the 7th day postoperatively HAMD-17, Hamilton Depression Scale 17-item (0-54 score) The total score was more than 24 as severe depression, more than 17 as mild or moderate depression, and less than 7 as no depressive symptoms.
The higher the total score, the higher the degree of depression
on the 7th day postoperatively
Secondary the HAMD-17 score at 1 day, 3 days and 30 days postoperatively HAMD-17, Hamilton Depression Scale 17-item (0-54 score) The total score was more than 24 as severe depression, more than 17 as mild or moderate depression, and less than 7 as no depressive symptoms.
The higher the total score, the higher the degree of depression
at 1 day, 3 days and 30 days postoperatively
Secondary the NRS scores at PACU, 1 day, 2 days and 7 days postoperatively NRS, numeric rating scale The digital pain score scale uses 0-10 points to represent different degrees of pain, 0 for no pain and 10 for severe pain. Patients score pain according to their own subjective feelings.
Score criteria:
0: painless 1-3: mild pain 4-6: moderate pain 7-10: severe pain
baseline (at PACU), 1 day, 2 days and 7 days postoperatively
Secondary the level of C-reactive Protein (CRP) at 1 day and 3 days postoperatively at 1 day and 3 days postoperatively
Secondary the level of interleukin 6 (IL-6) at 1 day and 3 days postoperatively at 1 day and 3 days postoperatively
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