Changes in Etomidate Dosage in Insomnia Patients Undergoing Digestive Endoscopy

NCT ID: NCT07028177

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

840 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-12

Study Completion Date

2027-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Insomnia Digestive Endoscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Insomnia group

Patients with insomnia

No interventions, it is a observational study

Intervention Type OTHER

No interventions, this study is to compare the dosage requirement of etomidate during digestive endoscopy between insomnia group and normal sleep group.

Normal sleep group

Patients with normal sleep

No interventions, it is a observational study

Intervention Type OTHER

No interventions, this study is to compare the dosage requirement of etomidate during digestive endoscopy between insomnia group and normal sleep group.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No interventions, it is a observational study

No interventions, this study is to compare the dosage requirement of etomidate during digestive endoscopy between insomnia group and normal sleep group.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with insomnia:

1. Age of 18 - 64 years;
2. American Society of Anesthesiologists (ASA) physical status of I - II;
3. Body mass index (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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Daxing Teaching Hospital, Capital Medical University

UNKNOWN

Sponsor Role collaborator

Hebei Medical University Third Hospital

OTHER

Sponsor Role collaborator

Hengshui People's Hospital

OTHER

Sponsor Role collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fang Luo

Director of Department of Day surgery and Pain Management Affiliation: Beijing Tiantan Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Fang Luo, M.D.

Role: primary

13611326978

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KY2024-091-02-3

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.