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

NCT05506787 | Completed Phase 4

• 1 other identifier: 2020NZKY-062-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease; Depression; Esketamine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  at 1 day, 3 days and 30 days postoperatively

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

  baseline (at PACU), 1 day, 2 days and 7 days postoperatively

• 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

Study Arms (2)

Esketamine Group

EXPERIMENTAL

The patients in S-ketamine group received 0.25 mg/kg intravenous S-ketamine (Jiangsu Hengrui Pharmaceutical Co., Ltd., Jiangsu, China) drip under general anesthesia induction, followed by continuous infusion of S-ketamine with 0.12 mg/kg/h for more than 30 minutes through target-controlled infusion. Drug A: S-ketamine, diluted to 1mg/ml with normal saline, total 50ml).

Drug: Esketamine

Placebo Group

PLACEBO COMPARATOR

Patients in Placebo group received intravenous infusion of 0.9% saline during anesthesia induction and were maintained through the infusion pump of drug B (50 ml 0.9% saline) for more than 30 minutes.

Drug: Placebo

Interventions

Esketamine DRUG

Esketamine

Esketamine Group

Placebo DRUG

Placebo

Placebo Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Anesthesiology Department, Jinling Hospital Affiliated to Nanjing University

Nanjing, Jiangsu, 210018, China

Location

MeSH Terms

Conditions

Crohn Disease; Depression

Interventions

Esketamine

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Behavioral Symptoms; Behavior

Study Officials

• Ji Qing

  Anesthesiology Department, Jinling Hospital Affiliated to Nanjing University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: August 14, 2022
• First Posted: August 18, 2022
• Study Start: September 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2022
• Last Updated: April 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)