Status:
RECRUITING
Changes in Ciprofol Dosage in Insomnia Patients Undergoing Digestive Endoscopy
Lead Sponsor:
Beijing Tiantan Hospital
Collaborating Sponsors:
Daxing Teaching Hospital, Capital Medical University
Hebei Medical University Third Hospital
Conditions:
Insomnia
Digestive Endoscopy
Eligibility:
All Genders
18-64 years
Brief Summary
To compare the dosage requirement of ciprofol during digestive endoscopy between patients with insomnia and those with normal sleep pattern.
Detailed Description
The investigators aim to investigate whether ciprofol dosage requirement is increased in patients with insomnia undergoing digestive endoscopy compared with normal sleep patterns.
Eligibility Criteria
Inclusion
- Patients with insomnia:
- Age of 18 - 64 years;
- ASA physical status of I - II;
- BMI of 15 - 30;
- Scheduled for digestive endoscopy under intravenous anesthesia;
- Positive screening results according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for insomnia disorder;
- 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:
- Age of 18 - 64 years;
- ASA physical status of I - II;
- BMI of 15 - 30;
- Scheduled for digestive endoscopy under intravenous anesthesia;
- No history or evidence of insomnia.
Exclusion
- Associated with any neurological disease;
- Daily alcohol consumption;
- Any contraindication to intravenous anesthetic drug, such as hypotension or shock;
- History of allergy to any drug used in the study;
- Pregnancy or breastfeeding;
- Patients with sleep apnea syndrome;
- acute upper respiratory infection;
- Patients with psychological diseases who report suicidal thoughts;
- Patients who need to work or take care of children/elderly people frequently at night.
Key Trial Info
Start Date :
March 24 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
840 Patients enrolled
Trial Details
Trial ID
NCT06897007
Start Date
March 24 2025
End Date
March 31 2027
Last Update
September 10 2025
Active Locations (1)
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1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100070