Painless Gastroenteroscopy in Elderly Patients
Conditions
Interventions
Single-Arm Sequential Study:Remimazolam 0.3 mg/kg intravenous bolus induction, followed by dynamic remifentanil dose adjustment (initial 0.10 µg/kg, increment 0.02 µg/kg, range 0–0.40 µg/kg) for dose
if sedation inadequacy or positive response occurs, remimazolam is supplemented per protocol (maximum total dose 0.5 mg/kg) or propofol rescue is initiated.
This study does not use conventional parall
instead, it employs a biased-coin up-and-down sequential allocation design. The initial remifentanil dose for the first participant is set at 0.10 µg/kg. Subsequent doses are adjusted according to the
if no positive response occurs, the dose for the next participant is determined by biased-coin randomization, with a 1/9 probability of decreasing by 0.02 µg/kg and an 8/9 probability of remaining unc
Sponsors
The Fifth People's Hospital of Huai'an
Eligibility
Sex/Gender
All
Age
65 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. age 65–80 years; 2. ASA physical status II–III; 3. BMI 18.5–28 kg/m^2; 4. scheduled to undergo elective painless gastrointestinal endoscopy; and 5. fully informed about the study, willing to participate voluntarily, and having signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. language, visual, hearing, psychiatric, psychological, or neurological disorders precluding effective communication, informed consent, or procedural cooperation; 2. cerebrovascular accident, myocardial infarction, or unstable angina within the previous 3 months, or severe cardiac, hepatic, or renal dysfunction; 3. major airway or respiratory risk factors, including severe obstructive sleep apnea, a history of difficult airway, or acute or severe bronchial asthma; 4. known allergy or contraindication to remimazolam, remifentanil, or propofol; 5. use within 48 hours before the procedure of opioids, sedative-hypnotics, or other centrally acting drugs that could affect the assessment of sedation or respiratory function; 6. chronic pain or cancer pain requiring long-term medication; 7. participation in another drug clinical trial within the previous 3 months; and 8. any other condition deemed by the investigators to render the participant unsuitable for enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Whether a positive response occurred during gastroscope insertion or within 1 minute after insertion.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean arterial pressure at each time point;Heart rate at each time point;Oxygen saturation at each time point;Time of examination;Time of awakening;Time to discharge;Induction time;Other perioperative adverse reactions; | — |
Countries
China
Contacts
Public ContactJi Yongjiu
The Fifth People's Hospital of Huai'an
Outcome results
None listed