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

Recruiting

• Conditions: Insomnia; Digestive Endoscopy
• Interventions: Other: No interventions, it is a observational study

• Registration Number: NCT06376760
• Lead Sponsor: Beijing Tiantan Hospital

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.

Study Timeline

• Study First Submitted: 2024-04-13
• Study Start: 2024-04-15
• Study First Submitted QC: 2024-04-17
• Study First Posted: 2024-04-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3360

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Insomnia group	No interventions, it is a observational study	Patients with insomnia
Normal sleep group	No interventions, it is a observational study	Patients with normal sleep

Primary Outcome Measures

Name	Time	Method
The total consumption of intravenous anesthetic drug	Up to 1 day	The total consumption of intravenous anesthetic drug for digestive endoscopy. It includes the total amount of intravenous anesthesia drugs required by the patient for the entire process of digestive endoscopy.

Secondary Outcome Measures

Name	Time	Method
The occurrence of the other adverse events	The day for patients undergoing digestive endoscopy and 24 hours after the digestive endoscopy	The occurrence of the other adverse events such as dizziness, agitation, nausea, vomiting and psychiatric symptom
The incidence of intraoperative recall or awareness	The day for patients undergoing digestive endoscopy and 24 hours after the digestive endoscopy	The patient is conscious after anesthesia
The dosage of intravenous anesthetic drug for successful insertion of digestive endoscope	1 day	The dosage of intravenous anesthetic drug for successful insertion of digestive endoscope
Duration of patients' PACU stay	Up to 1 day	Patients' stay time in PACU
The recovery time	Up to 1 day	The time from when the patient stops intravenous anesthetic drug application to when they can open their eyes and nod their heads.
The occurrence of the respiratory and cardiovascular adverse events	The day for patients undergoing digestive endoscopy and 24 hours after the digestive endoscopy	The occurrence of the respiratory and cardiovascular adverse events such as hypoxemia, hypotension, hypertension, arrhythmia
The ease of operation at this level of sedation evaluated by the gastroenterologists	Up to 1 day	The ease of operation at this level of sedation (easy/medium/difficult) evaluated by the gastroenterologists
The satisfaction degree of anesthesia effect evaluated by the gastroenterologists	Up to 1 day	The satisfaction degree of anesthesia effect (satisfactory/medium/unsatisfactory) evaluated by the gastroenterologists
Patients' satisfaction	Up to 1 day	Patients' satisfaction with the procedure at this level of sedation (satisfactory/medium/unsatisfactory)
Patients' willingness	Up to 1 day	Patients' willingness to undergo the next procedure at the same level of sedation

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China