Remimazolam Combined With Oliceridine for Sedation in Elderly Patients Undergoing Gastrointestinal Endoscopy
Hemodynamic and Oxygenation Profiles of Remimazolam Combined With Oliceridine Versus Sufentanil in Elderly Patients Undergoing Painless Gastrointestinal Endoscopy: A Randomized, Double-blind, Controlled Trial
Baoshan Branch, Renji Hospital, Shanghai Jiao Tong University School of Medicine
240 participants
Jul 17, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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).
- Fried frailty phenotype score < 3.
- Mini-Mental State Examination (MMSE) score ≥ 27.
- Provision of written informed consent by the patient or legal representative.
Exclusion Criteria9
- 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.
- Difficult airway or severe respiratory dysfunction.
- Cognitive impairment, psychiatric disease, or inability to cooperate with assessment.
- New York Heart Association (NYHA) functional class III or higher\[cite: 3\].
- Fried frailty phenotype score ≥ 3.
- Use of sedative or analgesic drugs within 24 hours before enrollment.
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Interventions
Administered intravenously for sedation induction and maintenance during gastrointestinal endoscopy. The dosage will be titrated according to the patient's sedation depth and clinical response.
Administered intravenously before or during the procedure to provide stable analgesic cooperation and optimize procedural sedation quality in elderly patients.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07707258