Healthy VolunteersNCT07471893
Optimal Insertion Time During Remimazolam-Remifentanil Anesthesia for Painless Gastroscopy
A study testing Dual criterion (absent jaw reflex + stable heart rate) guided endoscope insertion and Eyelash reflex guided endoscope insertionn in people with Healthy Volunteers, run by Huizhou First Hospital at 1 site in China.
Trial summary
This is a prospective clinical study to compare the anesthetic effect of remimazolam combined with remifentanil administered at different time points during gastroscope insertion in patients undergoing painless gastroscopy.The primary outcomes include sedation effect, intraoperative hemodynamic stability, recovery… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Dual criterion (absent jaw reflex + stable heart rate) guided endoscope insertion and Eyelash reflex guided endoscope insertionn
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2024to 8 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA physical status Ⅰ/Ⅱ, BMI 18-24kg/m², scheduled for elective diagnostic painless gastroscopy
Who cannot join
- (1) Allergy to remimazolam, remifentanil, BZDs, or opioids; (2) Difficult airway (Mallampati class Ⅲ/Ⅳ,limited mandibular movement, or restricted neck extension);(3)Severe cardiovascular/cerebrovascular/respiratory/hepatic/renal dysfunction;(4)Pregnancy/lactation;(5)Chronic use of sedatives/analgesics/psychotropic drugs; (6) Preoperative pulmonary infection/respiratory failure; (7) Inability to provide informed consent or complete follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Insertion Time During Remimazolam-Remifentanil Anesthesia for Painless Gastroscopy: A Single-Center Randomized Controlled Trial
This is a prospective clinical study to compare the anesthetic effect of remimazolam combined with remifentanil administered at different time points during gastroscope insertion in patients undergoing painless gastroscopy.The primary outcomes include sedation effect, intraoperative hemodynamic stability, recovery time, and adverse events.
Read the detailed description
This study hypothesized that a dual criterion (absent jaw reflex and stable heart rate) for guiding endoscope insertion is superior to the single eyelash reflex criterion in painless gastroscopy with remimazolam and remifentanil. A short delay after heart rate stabilization may achieve the best balance of safety and efficacy. This randomized controlled trial aims to verify the dual criterion, determine the optimal insertion time window, and establish a standardized clinical protocol.
- Conditions
- Healthy Volunteers
- Being tested
- Dual criterion (absent jaw reflex + stable heart rate) guided endoscope insertion, Eyelash reflex guided endoscope insertionn
- Keywords
- Painless gastroscopy, remimazolam, remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual criterion (absent jaw reflex + stable heart rate) guided endoscope insertionOther
Intravenous sedation and analgesia with remimazolam combined with remifentanil. Endoscope insertion is performed when jaw reflex is absent and heart rate is stable.
Eyelash reflex guided endoscope insertionnOther
Intravenous sedation and analgesia with remimazolam combined with remifentanil. Endoscope insertion is performed when eyelash reflex is absent.
| Study group | Role | What they receive |
|---|---|---|
| G group | Experimental | The timing point for gastroscope insertion was defined as when the patient's mandible was lifted, no motor response was observed any longer, and the h Receives: Other: Dual criterion (absent jaw reflex + stable heart rate) guided endoscope insertion |
| C group | Active comparator | The timing point for gastroscope insertion was determined when the corneal reflex was absent. Receives: Other: Eyelash reflex guided endoscope insertionn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough
Incidence of coughing during endoscope insertion and examination
Measured: From start of endoscope insertion until completion of gastroscopy
Body movement
Incidence of body movement
Measured: From start of endoscope insertion until completion of gastroscopy
Hypotension
Incidence of hypotension
Measured: From start of endoscope insertion until completion of gastroscopy
Bradycardia
Incidence of bradycardia
Measured: From start of endoscope insertion until completion of gastroscopy
Hypoxemia
Incidence of hypoxemia
Measured: From start of endoscope insertion until completion of gastroscopy
Secondary outcomes (2)
Endoscopist satisfaction score
Endoscopist satisfaction score
Measured: Immediately after completion of gastroscopy
PACU discharge time
Time to discharge from PACU
Measured: From admission to PACU until discharge from PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start8 May 2024
- Primary completion8 Dec 2025
- Study completion8 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, parallel-group, controlled clinical study. Eligible patients will be randomly assigned to two or more groups to compare different timing criteria for endoscope insertion during painless gastroscopy.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huizhou First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianhao Zeng, Huizhou First Hospital
- Investigators
- Jianhao Zeng, MD, Principal investigator, Huizhou First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471893
- Sponsor's protocol ID
- KYLL-2024-023-01
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant privacy and due to limited data management resources.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Insertion Time During Remimazolam-Remifentanil Anesthesia for Painless Gastroscopy: A Single-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07471893
- Acronym / sponsor ID
- KYLL-2024-023-01
- Conditions
- Healthy Volunteers
- Keywords
- Painless gastroscopy, remimazolam, remifentanil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Huizhou First HospitalUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 13 Mar 2026 (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.
This is a prospective clinical study to compare the anesthetic effect of remimazolam combined with remifentanil administered at different time points during gastroscope insertion in patients undergoing painless gastroscopy.The primary outcomes include sedation effect, intraoperative hemodynamic stability, recovery time, and adverse events.
Detailed description
This study hypothesized that a dual criterion (absent jaw reflex and stable heart rate) for guiding endoscope insertion is superior to the single eyelash reflex criterion in painless gastroscopy with remimazolam and remifentanil. A short delay after heart rate stabilization may achieve the best balance of safety and efficacy. This randomized controlled trial aims to verify the dual criterion, determine the optimal insertion time window, and establish a standardized clinical protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, parallel-group, controlled clinical study. Eligible patients will be randomly assigned to two or more groups to compare different timing criteria for endoscope insertion during painless gastroscopy.
| Arm | Type | Receives |
|---|---|---|
| G group | Experimental | Other: Dual criterion (absent jaw reflex + stable heart rate) guided endoscope insertionThe timing point for gastroscope insertion was defined as when the patient's mandible was lifted, no motor response was observed any longer, and the h |
| C group | Active comparator | Other: Eyelash reflex guided endoscope insertionnThe timing point for gastroscope insertion was determined when the corneal reflex was absent. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA physical status Ⅰ/Ⅱ, BMI 18-24kg/m², scheduled for elective diagnostic painless gastroscopy
Key exclusion criteria (1 listed)
- (1) Allergy to remimazolam, remifentanil, BZDs, or opioids; (2) Difficult airway (Mallampati class Ⅲ/Ⅳ,limited mandibular movement, or restricted neck extension);(3)Severe cardiovascular/cerebrovascular/respiratory/hepatic/renal dysfunction;(4)Pregnancy/lactation;(5)Chronic use of sedatives/analgesics/psychotropic drugs; (6) Preoperative pulmonary infection/respiratory failure; (7) Inability to provide informed consent or complete follow-up.
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 |
|---|---|---|
| Dual criterion (absent jaw reflex + stable heart rate) guided endoscope insertionIntravenous sedation and analgesia with remimazolam combined with remifentanil. Endoscope insertion is performed when jaw reflex is absent and heart rate is stable. | Other | G group |
| Eyelash reflex guided endoscope insertionnIntravenous sedation and analgesia with remimazolam combined with remifentanil. Endoscope insertion is performed when eyelash reflex is absent. | Other | C group |
Primary outcome
Cough
Time frame: From start of endoscope insertion until completion of gastroscopy
Incidence of coughing during endoscope insertion and examination
Body movement
Time frame: From start of endoscope insertion until completion of gastroscopy
Incidence of body movement
Hypotension
Time frame: From start of endoscope insertion until completion of gastroscopy
Incidence of hypotension
Bradycardia
Time frame: From start of endoscope insertion until completion of gastroscopy
Incidence of bradycardia
Hypoxemia
Time frame: From start of endoscope insertion until completion of gastroscopy
Incidence of hypoxemia
2 secondary outcomes
Endoscopist satisfaction score
Time frame: Immediately after completion of gastroscopy
PACU discharge time
Time frame: From admission to PACU until discharge from PACU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant privacy and due to limited data management resources.
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Screening Protocol
Pain
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. This study is not recruiting at the moment.
Jianhao Zeng, MD principal investigator
Huizhou First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual criterion (absent jaw reflex + stable heart rate) guided endoscope insertion and Eyelash reflex guided endoscope insertionn in people with Healthy Volunteers, run by Huizhou First 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 1 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: finished, as of the sponsor's last update on 13 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough (time frame: From start of endoscope insertion until completion of gastroscopy). The study lists 5 primary outcomes in all. 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 13 Mar 2026.