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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| C group | Active Comparator | The timing point for gastroscope insertion was determined when the corneal reflex was absent. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual criterion (absent jaw reflex + stable heart rate) guided endoscope insertion | Other | Intravenous sedation and analgesia with remimazolam combined with remifentanil. Endoscope insertion is performed when jaw reflex is absent and heart rate is stable. |
| Measure | Description | Time Frame |
|---|---|---|
| Cough | Incidence of coughing during endoscope insertion and examination | From start of endoscope insertion until completion of gastroscopy |
| Body movement | Incidence of body movement | From start of endoscope insertion until completion of gastroscopy |
| Hypotension | Incidence of hypotension | From start of endoscope insertion until completion of gastroscopy |
| Bradycardia | Incidence of bradycardia | From start of endoscope insertion until completion of gastroscopy |
| Hypoxemia | Incidence of hypoxemia | From start of endoscope insertion until completion of gastroscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopist satisfaction score | Endoscopist satisfaction score | Immediately after completion of gastroscopy |
| PACU discharge time | Time to discharge from PACU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianhao Zeng, MD | Huizhou First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huizhou First People's Hospital | Huizhou | Guangdong | China |
Individual participant data will not be shared to protect participant privacy and due to limited data management resources.
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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.
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Participants, anesthesiologists performing the procedure, and outcome assessors are blinded to group allocation.Group assignment is concealed using a random number table or central randomization system.
| Eyelash reflex guided endoscope insertionn | Other | Intravenous sedation and analgesia with remimazolam combined with remifentanil. Endoscope insertion is performed when eyelash reflex is absent. |
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| From admission to PACU until discharge from PACU |