Efficacy of Esketamine for Patients With Irritable Bowel Syndrome

NCT ID: NCT06788444

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 552 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-18
• Study Completion Date: 2027-12-31

Brief Summary

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

Detailed Description

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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

The esketamine group

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.

Group Type: EXPERIMENTAL

The colonoscopy

Intervention Type: 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

Intervention Type: 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.

The control group

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.

Group Type: PLACEBO_COMPARATOR

The colonoscopy

Intervention Type: 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.

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age of 18 - 60 years;

2. American Society of Anesthesiologists (ASA) physical status of I - II;

3. Body Mass Index (BMI) of 15 - 30;

4. Scheduled for colonoscopy;

5. Positive screening results according to the Rome IV diagnostic criteria for IBS;

6. 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

1. GastrointestinalTract (GI) bleeding;

2. Any organic lesions confirmed by clinical examination, laboratory examination or colonoscopy；

3. A previous diagnosis of colon cancer, infammatory bowel disease or coeliac disease;

4. A history of weight loss (at least 10%) within six months;

5. A history of abdominal surgery (other than hernia repair or appendectomy);

6. Participate in other clinical trials within 3 months;

7. Patients older than 55 years of age who have not undergone a colonoscopy in the past 5 years；

8. Mental disorder patients with severe personality disorder, active suicidal ideation and history of self-harm within 1 year;

9. Allergy or any contraindications to the drugs used in the study, such as severe cardiovascular disease, refractory hypertension, or hyperthyroidism;

10. Drinking more than 50 units (1 unit refers to 10ml of pure alcohol) per week;

11. Pregnancy or breastfeeding.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fang Luo

Director of Department of Day surgery and Pain Management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Fang Luo, M.D

Role: primary

13611326978@163.com

+86 13611326978

Zhe Sun

Role: backup

sunzhe199203@126.com

+8615801624623

References

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.

Reference Type: DERIVED

PMID: 40550724 (View on PubMed)

Other Identifiers

KY2024-414-02

Identifier Type: -

Identifier Source: org_study_id