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Completed

NCT Number: NCT05506787

The Effects of Intraoperative Esketamine on Postoperative Pain and Mood in Patients With Inflammatory Bowel Disease

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Anesthesiology Department, Jinling Hospital Affiliated to Nanjing University

Nanjing, Jiangsu, 210018, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • 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.

Treatment and study plan

Esketamine

Drug

Esketamine

Placebo

Drug

Placebo

Primary outcomes

  1. the HAMD-17 score on the 7th day postoperatively

    Time frame: 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 outcomes

  1. the HAMD-17 score at 1 day, 3 days and 30 days postoperatively

    Time frame: 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

  2. the NRS scores at PACU, 1 day, 2 days and 7 days postoperatively

    Time frame: 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

  3. the level of C-reactive Protein (CRP) at 1 day and 3 days postoperatively

    Time frame: at 1 day and 3 days postoperatively

  4. the level of interleukin 6 (IL-6) at 1 day and 3 days postoperatively

    Time frame: at 1 day and 3 days postoperatively

Sponsors and collaborators

Lead sponsor

Jinling Hospital, China

Other

Registry information

Official study title

Effects of Intraoperative Low-dose S-ketamine on Postoperative Mood and Pain in Patients With Crohn's Disease Undergoing Enterectomy With Mild to Moderate Depression: a Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 18, 2022
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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