Healthy Volunteers
Conditions
Keywords
Painless gastroscopy, remimazolam, remifentanil
Brief 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 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.
Interventions
OTHERDual criterion (absent jaw reflex + stable heart rate) guided endoscope insertion
Intravenous sedation and analgesia with remimazolam combined with remifentanil. Endoscope insertion is performed when jaw reflex is absent and heart rate is stable.
OTHEREyelash reflex guided endoscope insertionn
Intravenous sedation and analgesia with remimazolam combined with remifentanil. Endoscope insertion is performed when eyelash reflex is absent.
Sponsors
Huizhou First People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* ASA physical status Ⅰ/Ⅱ, BMI 18-24kg/m², scheduled for elective diagnostic painless gastroscopy
Exclusion criteria
* (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cough | From start of endoscope insertion until completion of gastroscopy | Incidence of coughing during endoscope insertion and examination |
| Body movement | From start of endoscope insertion until completion of gastroscopy | Incidence of body movement |
| Hypotension | From start of endoscope insertion until completion of gastroscopy | Incidence of hypotension |
| Bradycardia | From start of endoscope insertion until completion of gastroscopy | Incidence of bradycardia |
| Hypoxemia | From start of endoscope insertion until completion of gastroscopy | Incidence of hypoxemia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopist satisfaction score | Immediately after completion of gastroscopy | Endoscopist satisfaction score |
| PACU discharge time | From admission to PACU until discharge from PACU | Time to discharge from PACU |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORJianhao Zeng, MD
Huizhou First People's Hospital
Outcome results
None listed