RecruitingNot ApplicableNCT06788444

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

Sponsor

Beijing Tiantan Hospital

Enrollment

552 participants

Start Date

Sep 18, 2025

Study Type

INTERVENTIONAL

Conditions

Irritable Bowel Syndrome

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria6

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) .

Exclusion Criteria11

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.

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Interventions

PROCEDUREThe 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.

DRUGEsketamine

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.