Hemodynamic and Oxygenation Profiles of Remimazolam Combined With Oliceridine Versus Sufentanil in Elderly Patients Undergoing Painless Gastrointestinal Endoscopy: A Randomized, Double-blind, Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 80
Healthy Volunteers: f
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• 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.
Locations
Other Locations
China
Shanghai Baoshan District Dachang Hospital (Renji Hospital Baoshan Branch)
RECRUITING
Shanghai
Contact Information
Primary
Ling long Gong, PhD
350552970@qq.com
+86-17317107780
Time Frame
Start Date:2026-07-17
Estimated Completion Date:2026-12-01
Participants
Target number of participants:240
Treatments
Experimental: Remimazolam + Oliceridine Group
Patients in this group will receive a combination of remimazolam and oliceridine for sedation during painless gastrointestinal endoscopy. Remimazolam will be administered intravenously for induction and maintenance of sedation, titrated to achieve an appropriate depth of anesthesia. Oliceridine will be administered intravenously to provide stable analgesic cooperation and reduce sedation-related adverse events.
Active_comparator: Active Control Group
Patients in this group will receive standard remimazolam monotherapy (or remimazolam combined with traditional opioids) for sedation during painless gastrointestinal endoscopy. remimazolam will be administered intravenously to induce and maintain the sedation required for the endoscopic procedure, adhering to standard clinical anesthesia management protocols.