Crohn Disease, Depression, Esketamine
Conditions
Brief 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.
Interventions
DRUGEsketamine
Esketamine
DRUGPlacebo
Placebo
Sponsors
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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 Ⅰ\ Ⅲ, (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the HAMD-17 score on the 7th day postoperatively | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the HAMD-17 score at 1 day, 3 days and 30 days postoperatively | 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 |
| the NRS scores at PACU, 1 day, 2 days and 7 days postoperatively | baseline (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 |
| the level of C-reactive Protein (CRP) at 1 day and 3 days postoperatively | at 1 day and 3 days postoperatively | — |
| the level of interleukin 6 (IL-6) at 1 day and 3 days postoperatively | at 1 day and 3 days postoperatively | — |
Countries
China
Outcome results
None listed