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To explore the efficacy of a single low dose of esketamine for patients with irritable bowel syndrome (IBS).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | 100050 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40550724 | Derived | 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. |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C000629870 | Esketamine |
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Parallel Assignment
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Single (Outcomes Assessor)
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| 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. |
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| 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 |
| D004066 | Digestive System Diseases |