Changes in Ciprofol Dosage in Insomnia Patients Undergoing Digestive Endoscopy

Changes in Ciprofol Dosage in Insomnia Patients Undergoing Digestive Endoscopy: a Prospective Cohort Study

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

Study Overview

• Status: Recruiting
• Conditions: Insomnia; Digestive Endoscopy
• Intervention / Treatment: Other: No interventions, it is a observational study

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 840

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100070
      • Recruiting
      • Beijing Tiantan Hospital
      • Principal Investigator: Fang Luo, M.D.
      • Contact: Fang Luo, M.D.; Phone Number: 13611326978; Email: 13611326978@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with insomnia and patients with normal sleep patterns

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Insomnia group; Patients with insomnia	Other: No interventions, it is a observational study; No interventions, this study is to compare the dosage requirement of ciprofol during digestive endoscopy between insomnia group and normal sleep group.
Normal sleep group; Patients with normal sleep	Other: No interventions, it is a observational study; No interventions, this study is to compare the dosage requirement of ciprofol during digestive endoscopy between insomnia group and normal sleep group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total consumption of ciprofol	The total consumption of ciprofol for digestive endoscopy. It includes the total amount of ciprofol required by the patient for the entire process of digestive endoscopy.	Up to 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Duration of patients' PACU stay	Patients' stay time in PACU	Up to 1 day
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
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
Patients' satisfaction	Patients' satisfaction with the procedure at this level of sedation (satisfactory/medium/unsatisfactory)	Up to 1 day
Patients' willingness	Patients' willingness to undergo the next procedure at the same level of sedation	Up to 1 day
The dosage of ciprofol for successful insertion of digestive endoscope	The dosage of ciprofol for successful insertion of digestive endoscope	1 day

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: Hebei Medical University Third Hospital; Hengshui People's Hospital; Daxing Teaching Hospital, Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Insomnia; Ciprofol; Digestive endoscopy
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: KY2024-091-02-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No