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Recruiting NCT07028190

Changes in Rimazolen Dosage in Insomnia Patients Undergoing Digestive Endoscopy

Trial Parameters

Condition Insomnia
Sponsor Beijing Tiantan Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 840
Sex ALL
Min Age 18 Years
Max Age 64 Years
Start Date 2025-06-12
Completion 2027-03-31
Interventions
No interventions, it is a observational study

Brief Summary

To compare the dosage requirement of rimazolen during digestive endoscopy between patients with insomnia and those with normal sleep pattern.

Eligibility 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. 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;

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