RecruitingNCT06376760

Changes in Intravenous Anesthetic Drug Dosage in Insomnia Patients Undergoing Digestive Endoscopy

Changes in Intravenous Anesthetic Drug Dosage in Insomnia Patients Undergoing Digestive Endoscopy: Study Protocol for a Prospective Cohort Study

Sponsor

Beijing Tiantan Hospital

Enrollment

3,360 participants

Start Date

Apr 15, 2024

Study Type

OBSERVATIONAL

Conditions

Insomnia Digestive Endoscopy

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 64 Years

Inclusion Criteria13

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 Criteria1

\. 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERNo interventions, it is a observational study

No interventions, this study is to compare the dosage requirement of intravenous anesthetic drug during digestive endoscopy between insomnia group and normal sleep group.