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NCT06897007
Changes in Ciprofol Dosage in Patients With Insomnia Undergoing Intravenous Anesthesia
Conditions: Insomnia, Digestive Endoscopy
Sex: All
Ages: 18 Years – 64 Years
Healthy volunteers: No
Enrollment: 840
Sponsor: Beijing Tiantan Hospital
Location: Beijing Tiantan Hospital Beijing Beijing Municipality
Summary
To compare the dosage requirement of ciprofol under intravenous anesthesia between patients with insomnia and those with normal sleep pattern.
Eligibility 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. Patients undergoing elective thoracoscopy, laparoscopy, hysteroscopy, open abdominal surgery, open thoracic surgery, open spinal surgery, craniotomy surgery, and digestive endoscopy under general 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. Patients undergoing elective thoracoscopy, laparoscopy, hysteroscopy, open abdominal surgery, open thoracic surgery, open spinal surgery, craniotomy surgery, and digestive endoscopy under general 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.
Source: ClinicalTrials.gov (NCT06897007). StuddyBuddy aggregates publicly available trial information.