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Recruiting NCT06376760

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

— Observational Insomnia Digestive Endoscopy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No interventions, it is a observational study.
Who it may be relevant to
Registry conditions: Insomnia, Digestive Endoscopy. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Detailed description

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

Interventions

  • Other No 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.

Primary outcome measures

  • The total consumption of intravenous anesthetic drug [Time frame: Up to 1 day]
Secondary outcome measures (10)
  • The dosage of intravenous anesthetic drug for successful insertion of digestive endoscope [Time frame: 1 day]
  • The occurrence of the respiratory and cardiovascular adverse events [Time frame: The day for patients undergoing digestive endoscopy and 24 hours after the digestive endoscopy]
  • The occurrence of the other adverse events [Time frame: The day for patients undergoing digestive endoscopy and 24 hours after the digestive endoscopy]
  • The incidence of intraoperative recall or awareness [Time frame: The day for patients undergoing digestive endoscopy and 24 hours after the digestive endoscopy]
  • The recovery time [Time frame: Up to 1 day]
  • Duration of patients' PACU stay [Time frame: Up to 1 day]
  • The ease of operation at this level of sedation evaluated by the gastroenterologists [Time frame: Up to 1 day]
  • The satisfaction degree of anesthesia effect evaluated by the gastroenterologists [Time frame: Up to 1 day]
  • Patients' satisfaction [Time frame: Up to 1 day]
  • Patients' willingness [Time frame: Up to 1 day]

Eligibility criteria

Inclusion criteria

  • 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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Beijing Tiantan Hospital — Beijing

Identifiers

NCT: NCT06376760 · KY2024-091-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗