Efficacy of Esketamine for Patients With Irritable Bowel Syndrome
ConditionIrritable Bowel Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorBeijing Tiantan Hospital
About this trial
To explore the efficacy of a single low dose of esketamine for patients with irritable bowel syndrome (IBS).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
The colonoscopy
Procedure/SurgeryBoth 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
DrugThe 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.
Treatment groups
552 Participants
are divided into 2 treatment groupsGroup A: The esketamine groupExperimental treatment 2 interventions
Group B: The control groupPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopySecondary outcomes
1
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.
Time frame
At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy2
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).
Time frame
At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy3
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.
Time frame
At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy,4
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.
Time frame
At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopySponsors and contacts
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Source ClinicalTrials.gov