Ciprofol dose needs for people with insomnia having digestive endoscopy.
Official title: Changes in Ciprofol Dosage in Patients With Insomnia Undergoing Intravenous Anesthesia: a Prospective Cohort Study
Run by Beijing Tiantan Hospital · NCT06897007 · Data updated 2026-11-12
This project will test whether people with insomnia need higher doses of ciprofol during digestive endoscopy than people with normal sleep.
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 | March 24, 2025 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | July 22, 2026 |
| Trial ID | NCT06897007 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 18–64 years old with ASA I–II and BMI 15–30 who are scheduled for digestive endoscopy under intravenous anesthesia, including a subgroup meeting DSM-5 criteria for insomnia with an SCI score of 16 or less.
✕Probably not a fit
Patients with neurological disease, daily alcohol use, contraindications to intravenous anesthetics, allergy to drugs used, pregnancy or breastfeeding, or diagnosed sleep apnea may not receive benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will observe adults aged 18–64 undergoing digestive endoscopy with intravenous anesthesia and compare the ciprofol dose required for adequate sedation between patients who meet DSM-5 criteria for insomnia (SCI ≤16) and those with normal sleep. Eligible participants are ASA physical status I–II with a BMI of 15–30 and will receive routine clinical ciprofol dosing while investigators record the total dose needed to reach sedation endpoints. This is an observational, non-interventional comparison with no alteration of standard care. The primary outcome is the difference in ciprofol dosing between the insomnia and normal-sleep groups.
Why it matters
Potential benefit: If successful, the findings could help clinicians tailor ciprofol dosing for patients with insomnia to improve sedation safety and comfort during endoscopy.
How similar studies have gone: Ciprofol has shown effectiveness and a favorable safety profile for procedural sedation in other clinical work, but specific data comparing dose requirements in patients with insomnia are limited and relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with insomnia: 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. 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
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Beijing Tiantan Hospital
Beijing, Beijing Municipality, China Recruiting
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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.