Efficacy of Esketamine for Patients With Irritable Bowel Syndrome

NCT06788444 | Recruiting

• 1 other identifier: KY2024-414-02
• Study Type: interventional
• Target: 552
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Irritable Bowel Syndrome

Keywords

Irritable bowel syndrome; esketamine

Outcome Measures

Primary Outcomes (1)

• The IBS Severity Scoring System (IBS-SSS)

  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.

  At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy

Secondary Outcomes (6)

• The IBS Quality of Life (IBS-QOL) questionnaire

  At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy

• The Bristol Stool Form (BSF) scale

  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 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 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy

• The respiratory and cardiovascular adverse events

  At baseline and at 24 hours after colonoscopy

Study Arms (2)

The esketamine group

EXPERIMENTAL

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.

Procedure: The colonoscopy; Drug: Esketamine

The control group

PLACEBO COMPARATOR

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.

Procedure: The colonoscopy

Interventions

The colonoscopy PROCEDURE

Both groups continued to receive the usual standard of gastroenterology care throughout the study period. The patients undergo preoperative preparation according to the requirements of colonoscopy. After entering the endoscopy room, the routine monitoring including electrocardiogram, heart rate, noninvasive blood pressure (BP), respiratory rate, and oxygen saturation (SpO2) are applied for patients. All monitoring data including HR, BP and SpO2 will be recorded at intervals of 3min. Safety assessments will be performed throughout the the research process. As a risk mitigation measure, esketamine should not be administered in patients with systolic blood pressure (SBP) \> 140 mmHg or diastolic blood pressure (DBP) \>90 mmHg prior to administration. After the right upper limb venous access is opened, the patients is placed in the left lateral position. The oxygen mask is placed near the patients' nose and oxygen is provided by the mask for 6L/min during the colonoscopy.

The control group; The esketamine group

Esketamine DRUG

The propofol is administered until the patients loss of consciousness (loss of the eyelash refex). The 0.2 mg/kg esketamine is then administered by the anesthesiologist, but should be discontinued if the SBP ≥200 mmHg or the DBP ≥110 mmHg. After the administration of the 0.2 mg/kg esketamine is completed, the endoscopist will begin the colonoscopic procedure.

The esketamine group

Eligibility Criteria

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

You may qualify if:

• Age of 18 - 60 years;
• American Society of Anesthesiologists (ASA) physical status of I - II;
• Body Mass Index (BMI) of 15 - 30;
• Scheduled for colonoscopy;
• Positive screening results according to the Rome IV diagnostic criteria for IBS;
• 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) .

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

Related Publications (1)

• Sun Z, Jiang L, Xing Y, Luo F. Efficacy of a single low dose of esketamine for patients with irritable bowel syndrome: study protocol for a randomised controlled trial. BMJ Open. 2025 Jun 23;15(6):e099793. doi: 10.1136/bmjopen-2025-099793.

  PMID: 40550724 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Esketamine

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Day surgery and Pain Management

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 23, 2025
• Study Start: September 18, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)