Efficacy of Esketamine for Patients with Irritable Bowel Syndrome

Not Applicable

Not yet recruiting

• Conditions: Irritable Bowel Syndrome
• Interventions: Procedure: The colonoscopy; Drug: Esketamine

• Registration Number: NCT06788444
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

To explore the efficacy of a single low dose of esketamine for patients with irritable bowel syndrome (IBS).

Detailed Description

The investigators aim to investigate the efficacy of a single low dose of esketamine in patients with irritable bowel syndrome (IBS), and to explore the etiology of IBS and the effective and rapid treatment for this etiology.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-22
• Study First Posted: 2025-01-23
• Last Update Submitted: 2025-03-17
• Study Start: 2025-03-18
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 552

Inclusion Criteria

1. Age of 18 - 60 years;
2. American Society of Anesthesiologists (ASA) physical status of I - II;
3. Body Mass Index (BMI) of 15 - 30;
4. Scheduled for colonoscopy;
5. Positive screening results according to the Rome IV diagnostic criteria for IBS;
6. Patients who met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Anxiety disorder (ANXD) and/or major depressive disorder (MDD) .

Exclusion Criteria

1. GastrointestinalTract (GI) bleeding;
2. Any organic lesions confirmed by clinical examination, laboratory examination or colonoscopy；
3. A previous diagnosis of colon cancer, infammatory bowel disease or coeliac disease;
4. A history of weight loss (at least 10%) within six months;
5. A history of abdominal surgery (other than hernia repair or appendectomy);
6. Participate in other clinical trials within 3 months;
7. Patients older than 55 years of age who have not undergone a colonoscopy in the past 5 years；
8. Mental disorder patients with severe personality disorder, active suicidal ideation and history of self-harm within 1 year;
9. Allergy or any contraindications to the drugs used in the study, such as severe cardiovascular disease, refractory hypertension, or hyperthyroidism;
10. Drinking more than 50 units (1 unit refers to 10ml of pure alcohol) per week;
11. Pregnancy or breastfeeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The esketamine group	The colonoscopy	The propofol is administered until the patients loss of consciousness. Then 0.2 mg/kg esketamine is then administered by the anesthesiologist. After the administration of 0.2 mg/kg esketamine is completed, the endoscopist will begin the colonoscopic procedure.
The esketamine group	Esketamine	The propofol is administered until the patients loss of consciousness. Then 0.2 mg/kg esketamine is then administered by the anesthesiologist. After the administration of 0.2 mg/kg esketamine is completed, the endoscopist will begin the colonoscopic procedure.
The control group	The colonoscopy	The propofol is administered until the patients loss of consciousness. Then normal saline is then administered by the anesthesiologist. After the administration of normal saline is completed, the endoscopist will begin the colonoscopic procedure.

Primary Outcome Measures

Name	Time	Method
The IBS Severity Scoring System (IBS-SSS)	At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy	The IBS Severity Scoring System (IBS-SSS) at baseline and at 6 weeks after colonoscopy, which incorporates five typical symptoms of IBS (intensity of abdominal pain, frequency of abdominal pain, intensity of bloating, dissatisfaction with bowel habits, associated interference with daily life) \[54-56\]. Each symptom score ranges from 0 to 100 and a higher score indicates a more severe symptoms of IBS. The parenteral symptoms incorporates nausea/vomiting, early satiety, heartburn, headache, backache, body aches, thigh pain, lethargy, excess wind, and urinary symptoms. Patients with IBS may be categorized according to IBS-SSS, which are asymptomatic (\<75), mild (75-175), moderate (176-300), and severe (\>300). A reduction of ≥50 points is considered clinical improvement.

Secondary Outcome Measures

Name	Time	Method
The IBS Quality of Life (IBS-QOL) questionnaire	At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy	The IBS Quality of Life (IBS-QOL) questionnaire at baseline and at 6 weeks after colonoscopy, which consists of 8 subscales (dysphoria, activity interference, personal image, health concerns, food avoidance, social reaction, sexuality, social relationship), with a total of 34 questions. Each subscale score ranges from 0 to 100 points. A higher score indicates a better quality of life.
The Bristol Stool Form (BSF) scale	At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy	The Bristol Stool Form (BSF) scale at baseline and at 6 weeks after colonoscopy, which is used to record the difference in proportions of the patient's daily bowel habits (hard stools, normal stools, and loose stools).
The Hospital Anxiety and Depression Scale (HADS)	At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy,	The Hospital Anxiety and Depression Scale (HADS) at baseline and at 6 weeks after colonoscopy, which consists of two sub-scales. Each sub-scale consists of 7 items and each item scored from 0 to 3. A higher score indicates more severe anxiety or depression. A score of 11 or above can indicate clinically significant anxiety or depression.
The Patient Health Questionnaire-12 Somatic Symptom (PHQ-12 SS) Score	At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy	The Patient Health Questionnaire-12 Somatic Symptom (PHQ-12 SS) Score at baseline and at 6 weeks after colonoscopy, which includes 12 extra-GI symptoms such as back pain, limb pain, and headache. A higher score indicates more severe somatization symptoms.
The respiratory and cardiovascular adverse events	At baseline and at 24 hours after colonoscopy	The occurrence of the respiratory and cardiovascular adverse events such as tachycardia, elevated BP, hypotension, bradycardia and respiratory depression
The other adverse events	At baseline and at 24 hours after colonoscopy	The occurrence of the other adverse events such as nausea, vomiting, dizziness, agitation, sedation and hallucinations.

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China