InsomniaNCT06376760
Changes in Intravenous Anesthetic Drug Dosage in Insomnia Patients Undergoing Digestive Endoscopy
An observational study of Insomnia and Digestive Endoscopy, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
To compare the dosage requirement of intravenous anesthetics during digestive endoscopy between patients with insomnia and those with normal sleep pattern. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Insomnia, Digestive Endoscopy
- Type of treatment
- Injection or infusion
- How many people
- 3,360 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2024to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with insomnia and patients with normal sleep patterns
Who may be able to join
- Patients with insomnia:
- Age of 18 - 64 years;
- ASA physical status of I - II;
- 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;
Show all 13Show fewer
- 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:
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Fang Luo, M.D., 13611326978, 13611326978@163.com
Fang Luo, M.D.
About this study
Official title: Changes in Intravenous Anesthetic Drug Dosage in Insomnia Patients Undergoing Digestive Endoscopy: Study Protocol for a Prospective Cohort Study
To compare the dosage requirement of intravenous anesthetics during digestive endoscopy between patients with insomnia and those with normal sleep pattern.
Read the 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.
- Conditions
- Insomnia, Digestive Endoscopy
- Being tested
- No interventions, it is a observational study
- Keywords
- Digestive endoscopy, Insomnia, Intravenous anesthetic
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions, it is a observational studyOther
No interventions, this study is to compare the dosage requirement of intravenous anesthetic drug during digestive endoscopy between insomnia group and normal sleep group.
| Study group | Role | What they receive |
|---|---|---|
| Insomnia group | Patients with insomnia Receives: Other: No interventions, it is a observational study | |
| Normal sleep group | Patients with normal sleep Receives: Other: No interventions, it is a observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 day
Secondary outcomes (10)
The dosage of intravenous anesthetic drug for successful insertion of digestive endoscope
The dosage of intravenous anesthetic drug for successful insertion of digestive endoscope
Measured: 1 day
The occurrence of the respiratory and cardiovascular adverse events
The occurrence of the respiratory and cardiovascular adverse events such as hypoxemia, hypotension, hypertension, arrhythmia
Measured: 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
Measured: 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
Measured: 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.
Measured: Up to 1 day
Duration of patients' PACU stay
Patients' stay time in PACU
Measured: 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
Measured: 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
Measured: Up to 1 day
Patients' satisfaction
Patients' satisfaction with the procedure at this level of sedation (satisfactory/medium/unsatisfactory)
Measured: Up to 1 day
Patients' willingness
Patients' willingness to undergo the next procedure at the same level of sedation
Measured: Up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start17 Apr 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Daxing Teaching Hospital, Capital Medical University, Hebei Medical University Third Hospital, Hengshui People's Hospital
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376760
- Sponsor's protocol ID
- KY2024-091-02
- Status last verified
- Sep 2025
- First submitted
- 13 Apr 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Intravenous Anesthetic Drug Dosage in Insomnia Patients Undergoing Digestive Endoscopy: Study Protocol for a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06376760
- Acronym / sponsor ID
- KY2024-091-02
- Conditions
- Insomnia, Digestive Endoscopy
- Keywords
- Digestive endoscopy, Insomnia, Intravenous anesthetic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,360 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Daxing Teaching Hospital, Capital Medical University, Hebei Medical University Third Hospital, Hengshui People's Hospital
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insomnia group | – | Other: No interventions, it is a observational studyPatients with insomnia |
| Normal sleep group | – | Other: No interventions, it is a observational studyPatients with normal sleep |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with insomnia and patients with normal sleep patterns
Key inclusion criteria (13 listed)
- Patients with insomnia:
- Patients with normal sleep:
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventions, it is a observational studyNo interventions, this study is to compare the dosage requirement of intravenous anesthetic drug during digestive endoscopy between insomnia group and normal sleep group. | Other | Insomnia group, Normal sleep group |
Primary outcome
The total consumption of intravenous anesthetic drug
Time frame: 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.
10 secondary outcomes
The dosage of intravenous anesthetic drug for successful insertion of digestive endoscope
Time frame: 1 day
The occurrence of the respiratory and cardiovascular adverse events
Time frame: The day for patients undergoing digestive endoscopy and 24 hours after the digestive endoscopy
The occurrence of the other adverse events
Time frame: The day for patients undergoing digestive endoscopy and 24 hours after the digestive endoscopy
The incidence of intraoperative recall or awareness
Time frame: The day for patients undergoing digestive endoscopy and 24 hours after the digestive endoscopy
The recovery time
Time frame: Up to 1 day
Duration of patients' PACU stay
Time frame: Up to 1 day
The ease of operation at this level of sedation evaluated by the gastroenterologists
Time frame: Up to 1 day
The satisfaction degree of anesthesia effect evaluated by the gastroenterologists
Time frame: Up to 1 day
Patients' satisfaction
Time frame: Up to 1 day
Patients' willingness
Time frame: Up to 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia and Digestive Endoscopy, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total consumption of intravenous anesthetic drug (time frame: Up to 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.