NCT07028190

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
840

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress50%
Jun 2025Mar 2027

First Submitted

Initial submission to the registry

June 9, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

June 12, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

June 9, 2025

Last Update Submit

September 4, 2025

Conditions

InsomniaDigestive Endoscopy

Keywords

InsomniaDigestive endoscopyRimazolen

Outcome Measures

Primary Outcomes (1)

  • The total consumption of rimazolen

    The total consumption of rimazolen 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 Outcomes (10)

  • The dosage of rimazolen for successful insertion of digestive endoscope

    1 day

  • The occurrence of the respiratory and cardiovascular adverse events

    The day of the digestive endoscopy procedure and 24 hours after the digestive endoscopy

  • The occurrence of the other adverse events

    The day of the digestive endoscopy procedure and 24 hours after the digestive endoscopy

  • The incidence of intraoperative recall or awareness

    The day of the digestive endoscopy procedure and 24 hours after the digestive endoscopy

  • The recovery time

    Up to 1 day

  • +5 more secondary outcomes

Study Arms (2)

Insomnia group

Patients with insomnia

Other: No interventions, it is a observational study

Normal sleep group

Patients with normal sleep

Other: No interventions, it is a observational study

Interventions

No interventions, it is a observational studyOTHER

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

Insomnia groupNormal sleep group

Eligibility Criteria

Age18 Years - 64 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with insomnia and patients with normal sleep patterns

You may qualify if:

  • Patients with insomnia:
  • Age of 18 - 64 years;
  • American Society of Anesthesiologists (ASA) physical status of I - II;
  • Body mass index (BMI) of 15 - 30;
  • Scheduled for digestive endoscopy under intravenous anesthesia;
  • Positive screening results according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for insomnia disorder;
  • item Sleep Condition Indicator (SCI; score 0-4; range 0-32, higher score means better sleep) scored 16 or less;
  • Patients with normal sleep:
  • Age of 18 - 64 years;
  • ASA physical status of I - II;
  • BMI of 15 - 30;
  • Scheduled for digestive endoscopy under intravenous anesthesia;
  • No history or evidence of insomnia.

You may not qualify if:

  • Associated with any neurological disease;
  • Daily alcohol consumption;
  • Any contraindication to intravenous anesthetic drug, such as hypotension or shock;
  • History of allergy to any drug used in the study;
  • Pregnancy or breastfeeding;
  • Patients with sleep apnea syndrome;
  • acute upper respiratory infection;
  • Patients with psychological diseases who report suicidal thoughts;
  • Patients who need to work or take care of children/elderly people frequently at night.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Day surgery and Pain Management Affiliation: Beijing Tiantan Hospital

Study Record Dates

First Submitted

June 9, 2025

First Posted

June 19, 2025

Study Start

June 12, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

September 10, 2025

Record last verified: 2025-09

Locations

CN(1)