Ciprofol dose needs for people with insomnia having digestive endoscopy.

Changes in Ciprofol Dosage in Insomnia Patients Undergoing Digestive Endoscopy: a Prospective Cohort Study

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
• Enrollment: 840 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06897007 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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. 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)

Conditions: Insomnia, Digestive Endoscopy, Digestive endoscopy, Ciprofol