Efficacy of Esketamine for Patients With Irritable Bowel Syndrome

Efficacy of a Single Low Dose of Esketamine for Patients With Irritable Bowel Syndrome: Study Protocol for a Randomised Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Procedure: The colonoscopy; Drug: Esketamine

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 Type: Interventional
• Enrollment (Estimated): 552
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100050
      • Recruiting
      • Beijing Tiantan Hospital
      • Contact: Fang Luo, M.D; Phone Number: +86 13611326978; Email: 13611326978@163.com
      • Contact: Zhe Sun; Phone Number: +8615801624623; Email: sunzhe199203@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The esketamine group; 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; 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.; Drug: Esketamine; 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.
Placebo Comparator: The control group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The IBS Quality of Life (IBS-QOL) questionnaire	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.	At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy
The Bristol Stool Form (BSF) scale	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).	At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy
The Hospital Anxiety and Depression Scale (HADS)	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.	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	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.	At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy
The respiratory and cardiovascular adverse events	The occurrence of the respiratory and cardiovascular adverse events such as tachycardia, elevated BP, hypotension, bradycardia and respiratory depression	At baseline and at 24 hours after colonoscopy
The other adverse events	The occurrence of the other adverse events such as nausea, vomiting, dizziness, agitation, sedation and hallucinations.	At baseline and at 24 hours after colonoscopy

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: Hengshui People's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): January 23, 2025

Study Record Updates

• Last Update Posted (Actual): August 28, 2026
• Last Update Submitted That Met QC Criteria: August 26, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: esketamine; Irritable bowel syndrome
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome; Psychotropic Drugs; Antidepressive Agents; Esketamine
• Other Study ID Numbers: KY2024-414-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not yet decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No