Clinical trial NCT06376760: Changes in Intravenous Anesthetic Drug Dosage in Insomnia Patients Undergoing Digestive Endoscopy
Official title: Changes in Intravenous Anesthetic Drug Dosage in Insomnia Patients Undergoing Digestive Endoscopy: Study Protocol for a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Insomnia
Digestive Endoscopy
Keywords: Digestive endoscopy
Insomnia
Intravenous anesthetic
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 3360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with insomnia and patients with normal sleep patterns

Brief summary: 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.

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. 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.

Primary outcomes:
measure: The total consumption of intravenous anesthetic drug
timeFrame: Up to 1 day
Secondary outcomes:
measure: The dosage of intravenous anesthetic drug for successful insertion of digestive endoscope
timeFrame: 1 day
measure: The occurrence of the respiratory and cardiovascular adverse events
timeFrame: The day for patients undergoing digestive endoscopy and 24 hours after the digestive endoscopy
measure: The occurrence of the other adverse events
timeFrame: The day for patients undergoing digestive endoscopy and 24 hours after the digestive endoscopy
measure: The incidence of intraoperative recall or awareness
timeFrame: The day for patients undergoing digestive endoscopy and 24 hours after the digestive endoscopy
measure: The recovery time
timeFrame: Up to 1 day
measure: Duration of patients' PACU stay
timeFrame: Up to 1 day
measure: The ease of operation at this level of sedation evaluated by the gastroenterologists
timeFrame: Up to 1 day
measure: The satisfaction degree of anesthesia effect evaluated by the gastroenterologists
timeFrame: Up to 1 day
measure: Patients' satisfaction
timeFrame: Up to 1 day
measure: Patients' willingness
timeFrame: Up to 1 day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
References: