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NCT Number: NCT06788444

Efficacy of Esketamine for Patients With Irritable Bowel Syndrome

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

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. The IBS Severity Scoring System (IBS-SSS)

    Time frame: 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 outcomes

  1. The IBS Quality of Life (IBS-QOL) questionnaire

    Time frame: 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.

  2. The Bristol Stool Form (BSF) scale

    Time frame: 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).

  3. The Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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.

  4. The Patient Health Questionnaire-12 Somatic Symptom (PHQ-12 SS) Score

    Time frame: 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.

  5. The respiratory and cardiovascular adverse events

    Time frame: 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

  6. The other adverse events

    Time frame: At baseline and at 24 hours after colonoscopy

    The occurrence of the other adverse events such as nausea, vomiting, dizziness, agitation, sedation and hallucinations.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 23, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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