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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06376760
• Other study ID #: KY2024-091-02
• Status: Not yet recruiting
• Start date: April 15, 2024
• Est. completion date: March 31, 2027

Study information

• Verified date: April 2024
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3360
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

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