Comparing anesthetic dosage in insomnia patients during digestive endoscopy
Changes in Intravenous Anesthetic Drug Dosage in Insomnia Patients Undergoing Digestive Endoscopy: Study Protocol for a Prospective Cohort Study
This study looks at whether people with insomnia need different amounts of anesthesia during digestive endoscopy compared to those who sleep normally.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3360 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06376760 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the dosage requirements of intravenous anesthetics in patients with insomnia undergoing digestive endoscopy versus those with normal sleep patterns. The researchers will assess whether insomnia affects the amount of anesthetic needed for safe and effective sedation during the procedure. By analyzing the differences in dosage, the study seeks to provide insights into the management of anesthesia in patients with sleep disorders. No interventions will be applied, as the focus is on observational data collection.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-64 with insomnia or normal sleep patterns scheduled for digestive endoscopy under intravenous anesthesia.
Not a fit: Patients with neurological diseases, daily alcohol consumption, or contraindications to intravenous anesthetics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved anesthetic management for patients with insomnia undergoing endoscopic procedures.
How similar studies have performed: While similar studies on anesthetic dosage in various populations exist, this specific comparison between insomnia and normal sleep patterns is relatively novel.
Eligibility criteria
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. 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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.