Changes in Rimazolen Dosage in Insomnia Patients Undergoing Digestive Endoscopy

Capital Medical University

Status: Enrolling

Conditions: Insomnia; Digestive Endoscopy

Treatments: Other: No interventions, it is a observational study

Study type: Observational

Funder types: Other

Identifiers

NCT07028190

KY2024-091-02-4

Details and patient eligibility

About

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

Full description

The investigators aim to investigate whether rimazolen dosage requirement is increased in patients with insomnia undergoing digestive endoscopy compared with normal sleep patterns.

Enrollment: 840 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

840 participants in 2 patient groups

Insomnia group

Description:

Patients with insomnia

Treatment:

Other: No interventions, it is a observational study

Normal sleep group

Description:

Patients with normal sleep

Treatment:

Other: No interventions, it is a observational study