Etomidate dose needed for adults with insomnia during digestive endoscopy.
Changes in Etomidate Dosage in Insomnia Patients Undergoing Digestive Endoscopy: a Prospective Cohort Study
This will see if adults with insomnia need higher doses of etomidate than adults with normal sleep when having digestive endoscopy under intravenous anesthesia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 840 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07028177 on ClinicalTrials.gov |
What this trial studies
This observational study compares the amount of etomidate used to induce and maintain sedation during digestive endoscopy between adults with insomnia and adults with normal sleep patterns. Eligible participants are aged 18–64 with ASA physical status I–II and BMI 15–30 who are scheduled for digestive endoscopy under intravenous anesthesia, with insomnia defined by DSM-5 criteria and an SCI score of 16 or less. Investigators will record etomidate dose requirements and routine clinical outcomes without assigning experimental interventions. The work is led by Beijing Tiantan Hospital with collaboration from several regional hospitals.
Who should consider this trial
Good fit: Ideal candidates are adults 18–64 with ASA I–II and BMI 15–30 who are scheduled for digestive endoscopy under intravenous anesthesia and who meet 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, drug allergies, those outside the 18–64 age range, ASA class >II, BMI outside 15–30, or not undergoing endoscopy are unlikely to benefit from this observational comparison.
Why it matters
Potential benefit: If successful, the findings could help anesthesiologists tailor etomidate dosing for patients with insomnia to improve safety and comfort.
How similar studies have performed: Direct comparisons of etomidate dosing in insomnia versus normal sleepers are limited, so this approach is relatively novel with limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion 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; 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.