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Efficacy of Esketamine for Patients With Irritable Bowel Syndrome
Sponsor: Beijing Tiantan Hospital
Summary
To explore the efficacy of a single low dose of esketamine for patients with irritable bowel syndrome (IBS).
Official title: Efficacy of a Single Low Dose of Esketamine for Patients With Irritable Bowel Syndrome: Study Protocol for a Randomised Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
552
Start Date
2025-09-18
Completion Date
2027-12-31
Last Updated
2025-09-10
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (1)
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China