Rimazolen dosing during digestive endoscopy in people with insomnia
Official title: Changes in Rimazolen Dosage in Patients With Insomnia Under Intravenous Anesthesia: a Prospective Cohort Study
Run by Beijing Tiantan Hospital · NCT07028190 · Data updated 2026-11-12
This will see if people with insomnia need higher rimazolen doses than people with normal sleep during digestive endoscopy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 64 Years |
| Sex | All |
| Enrollment | 840 (estimated) |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | June 12, 2025 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | July 22, 2026 |
| Trial ID | NCT07028190 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Prior perioperative research suggests sleep disturbance can alter sedative requirements, but direct data on rimazolen dosing in insomnia patients are sparse.
Who can join: the full rules
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. Patients undergoing elective thoracoscopy, laparoscopy, hysteroscopy, open abdominal surgery, open thoracic surgery, open spinal surgery, craniotomy surgery, and digestive endoscopy under general 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. Patients undergoing elective thoracoscopy, laparoscopy, hysteroscopy, open abdominal surgery, open thoracic surgery, open spinal surgery, craniotomy surgery, and digestive endoscopy under general 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 it's running
-
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Etomidate dose needed for adults with insomnia during digestive endoscopy.
This will see if adults with insomnia need higher doses of etomidate than adults with normal sleep when having digestive endoscopy under intravenous anesthesia.
-
Ciprofol dose needs for people with insomnia having digestive endoscopy.
This project will test whether people with insomnia need higher doses of ciprofol during digestive endoscopy than people with normal sleep.
-
Comparing anesthetic dosage in insomnia patients during digestive endoscopy
This study looks at whether people with insomnia need different amounts of anesthesia during digestive endoscopy compared to those who sleep normally.
-
SleepCogni for children with chronic insomnia
A handheld SleepCogni device is tested to see if it helps kids aged 6–16 with chronic insomnia sleep better.
-
Music therapy after stroke
This trial tests whether adding music therapy to standard care helps stroke patients sleep better and feel less anxious or depressed while in the hospital.
-
Remote ischemic conditioning for post-stroke insomnia
A 136-person, randomized study will test whether a non-invasive arm-cuff procedure done twice daily for 90 days can improve sleep after a first ischemic stroke in adults 18–80.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.