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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-80
SponsorBaoshan Branch, Renji Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

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 criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Remimazolam Tosilate for Injection
  • Oliceridine Fumarate

Treatment groups

240 Participants
are divided into 2 treatment groups