This study aims to evaluate the sedative efficacy and safety of remimazolam combined with oliceridine in elderly patients undergoing painless gastrointestinal endoscopy. Elderly patients often face higher risks of respiratory and hemodynamic depression during clinical sedation. This trial will investigate whether the combination of remimazolam and oliceridine can provide stable sedation, maintain stable vital signs, and reduce the incidence of adverse events such as hypoxemia and postoperative cognitive fluctuation in this vulnerable population.
Elderly individuals scheduled to undergo painless gastrointestinal endoscopy.
Age between 65 and 80 years.
Body mass index (BMI) between 18 and 30 kg/m².
American Society of Anesthesiologists (ASA) physical status I-III (ASA III patients eligible only with mild-to-moderate dysfunction of a single organ system, without severe organ failure, and considered able to tolerate the procedure).
Allergy or contraindication to remimazolam, oliceridine, or sufentanil.
Liver or renal failure (Child-Pugh class C or eGFR < 30 mL/min).
Systemic infection, immunosuppression, coagulation disorder, upper gastrointestinal bleeding, or intestinal obstruction.
History of opioid dependence or long-term use of psychotropic drugs.
Parallel
Remimazolam Tosilate for Injection
DrugAdministered intravenously for sedation induction and maintenance during gastrointestinal endoscopy. The dosage will be titrated according to the patient's sedation depth and clinical response.
Oliceridine Fumarate
DrugAdministered intravenously before or during the procedure to provide stable analgesic cooperation and optimize procedural sedation quality in elderly patients.
Incidence of hypoxemia
The proportion of participants who experience at least one episode of hypoxemia during procedural sedation for gastrointestinal endoscopy. Hypoxemia is defined as peripheral oxygen saturation (SpO₂) \< 90%. SpO₂ will be continuously monitored throughout the observation period.
Incidence of Hypotension
The proportion of participants who experience at least one episode of hypotension during procedural sedation. Hypotension is defined as a decrease in mean arterial pressure (MAP) of more than 20% from the pre-induction baseline. MAP will be recorded at baseline and monitored throughout the observation period.
Sedation success rate
The proportion of patients who achieve a satisfactory sedation depth (MOAA/S score ≤ 1) without the need for rescue sedative medications.
Click on the lead sponsor to view all of their trials.
