Changes in Ciprofol Dosage in Insomnia Patients Undergoing Digestive Endoscopy

Launched by BEIJING TIANTAN HOSPITAL · Mar 20, 2025

Keywords

ClinConnect Summary

This clinical trial is looking into how the sleep patterns of patients might affect the amount of a medication called ciprofol needed during a procedure known as digestive endoscopy. Essentially, the researchers want to find out if patients who have trouble sleeping (insomnia) require different dosages of ciprofol compared to those who sleep normally. This study is important because it could help doctors provide better care for patients with insomnia who are undergoing this procedure.

To participate in the trial, you generally need to be between 18 and 64 years old and scheduled for a digestive endoscopy using intravenous anesthesia. If you have insomnia, you must meet specific criteria, including having a certain score on a sleep assessment tool. If you sleep normally, you should not have any history of insomnia. Participants will receive the procedure and medication as part of the study, and your responses will help researchers learn how to tailor treatment for different sleep patterns. If you have certain medical conditions or other factors, you may not be eligible, but the study team can provide more details.

Gender

ALL

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.