Rimazolen dosing during digestive endoscopy in people with insomnia
Changes in Rimazolen Dosage in Insomnia Patients Undergoing Digestive Endoscopy: a Prospective Cohort Study
This will see if people with insomnia need higher rimazolen doses than people with normal sleep during digestive endoscopy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 840 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07028190 on ClinicalTrials.gov |
What this trial studies
This observational study will compare rimazolen dose requirements in adults aged 18–64 undergoing digestive endoscopy with intravenous anesthesia who either meet DSM-5 criteria for insomnia or have normal sleep. Insomnia status is confirmed by DSM-5 screening and an 8-item Sleep Condition Indicator score of 16 or less, and comparisons will control for ASA status and BMI. Investigators will record rimazolen doses given during routine care along with clinical variables and contraindications to anesthetics. No experimental interventions are applied; data are collected during standard clinical procedures at the participating hospital.
Who should consider this trial
Good fit: Adults 18–64 years old with ASA physical status I–II and BMI 15–30 scheduled for digestive endoscopy under intravenous anesthesia who either meet DSM-5 criteria for insomnia with SCI ≤16 or have no history of insomnia.
Not a fit: Patients with neurological disease, daily alcohol use, contraindications or allergy to intravenous anesthetics, or those outside the specified age or BMI ranges are unlikely to benefit from the study findings.
Why it matters
Potential benefit: If rimazolen needs differ by sleep status, clinicians could tailor sedation doses to improve safety and comfort during endoscopy.
How similar studies have performed: Prior perioperative research suggests sleep disturbance can alter sedative requirements, but direct data on rimazolen dosing in insomnia patients are sparse.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with insomnia: 1. Age of 18 - 64 years; 2. American Society of Anesthesiologists (ASA) physical status of I - II; 3. Body mass index (BMI) of 15 - 30; 4. Scheduled for digestive endoscopy under intravenous anesthesia; 5. Positive screening results according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for insomnia disorder; 6. 8-item Sleep Condition Indicator (SCI; score 0-4; range 0-32, higher score means better sleep) scored 16 or less; * Patients with normal sleep: 1. Age of 18 - 64 years; 2. ASA physical status of I - II; 3. BMI of 15 - 30; 4. Scheduled for digestive endoscopy under intravenous anesthesia; 5. No history or evidence of insomnia. Exclusion Criteria: 1. Associated with any neurological disease; 2. Daily alcohol consumption; 3. Any contraindication to intravenous anesthetic drug, such as hypotension or shock; 4. History of allergy to any drug used in the study; 5. Pregnancy or breastfeeding; 6. Patients with sleep apnea syndrome; 7. acute upper respiratory infection; 8. Patients with psychological diseases who report suicidal thoughts; 9. Patients who need to work or take care of children/elderly people frequently at night.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.