Remimazolam Combined With Oliceridine for Sedation in Elderly Patients Undergoing Gastrointestinal Endoscopy

Recruiting now · Not applicable

Conditions studied: Sedation, Gastrointestinal Endoscopy

In brief

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.

Key facts

Study ID

NCT07707258

Run by

Baoshan Branch, Renji Hospital, Shanghai Jiao Tong University School of Medicine

People needed

240

Starts

2026-07-17

Expected to finish

2026-12-01

Last updated by the study team

2026-07-21

Who can join

Age: 65 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Shanghai Baoshan District Dachang Hospital (Renji Hospital Baoshan Branch) — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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