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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
342
Intravenous sedation and analgesia with remimazolam combined with remifentanil. Endoscope insertion is performed when jaw reflex is absent and heart rate is stable.
Intravenous sedation and analgesia with remimazolam combined with remifentanil. Endoscope insertion is performed when eyelash reflex is absent.
Huizhou First People's Hospital
Huizhou, Guangdong, China
Cough
Incidence of coughing during endoscope insertion and examination
Time frame: From start of endoscope insertion until completion of gastroscopy
Body movement
Incidence of body movement
Time frame: From start of endoscope insertion until completion of gastroscopy
Hypotension
Incidence of hypotension
Time frame: From start of endoscope insertion until completion of gastroscopy
Bradycardia
Incidence of bradycardia
Time frame: From start of endoscope insertion until completion of gastroscopy
Hypoxemia
Incidence of hypoxemia
Time frame: From start of endoscope insertion until completion of gastroscopy
Endoscopist satisfaction score
Endoscopist satisfaction score
Time frame: Immediately after completion of gastroscopy
PACU discharge time
Time to discharge from PACU
Time frame: From admission to PACU until discharge from PACU
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