Gastrointestinal Endoscopy, Sedation
Conditions
Keywords
Remimazolam, Oliceridine, Older Adults, Painless Gastrointestinal Endoscopy, Procedural Sedation, Hypoxemia
Brief 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.
Detailed description
This is a clinical study conducted at the Baoshan Branch of Renji Hospital, Shanghai Jiao Tong University School of Medicine. The study will strictly adhere to ethical guidelines, and all research activities will be carried out after receiving full approval from the Ethics Committee. Elderly participants will be enrolled based on predefined inclusion criteria with comprehensive vulnerability assessments. During the gastrointestinal endoscopy procedure, vital signs, particularly oxygen saturation (SpO2) and its duration of depression, will be monitored closely. To address potential educational bias in cognitive assessments, the study will utilize the Mini-Mental State Examination (MMSE) stratified by years of education alongside the Montreal Cognitive Assessment (MoCA) to comprehensively evaluate postoperative cognitive outcomes. Follow-up assessments will be systematically conducted at designated time points (e.g., 1 week, 1 month, 3 months, and 6 months) post-procedure.
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.
Sponsors
Baoshan Branch, Renji Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Patients are randomly assigned to different sedation protocol groups in a parallel manner.
Eligibility
Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Elderly individuals scheduled to undergo painless gastrointestinal endoscopy. 2. Age between 65 and 80 years. 3. Body mass index (BMI) between 18 and 30 kg/m². 4. 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). 5. Fried frailty phenotype score \< 3. 6. Mini-Mental State Examination (MMSE) score ≥ 27. 7. Provision of written informed consent by the patient or legal representative.
Exclusion criteria
1. Allergy or contraindication to remimazolam, oliceridine, or sufentanil. 2. Liver or renal failure (Child-Pugh class C or eGFR \< 30 mL/min). 3. Systemic infection, immunosuppression, coagulation disorder, upper gastrointestinal bleeding, or intestinal obstruction. 4. History of opioid dependence or long-term use of psychotropic drugs. 5. Difficult airway or severe respiratory dysfunction. 6. Cognitive impairment, psychiatric disease, or inability to cooperate with assessment. 7. New York Heart Association (NYHA) functional class III or higher\[cite: 3\]. 8. Fried frailty phenotype score ≥ 3. 9. Use of sedative or analgesic drugs within 24 hours before enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hypoxemia | From initiation of sedation induction to completion of the gastrointestinal endoscopic procedure, approximately 30 minutes. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Hypotension | From the pre-induction baseline assessment to transfer to the post-anesthesia care unit, up to 1 hour. | 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 | From the start of sedation induction to the completion of the endoscopic procedure | The proportion of patients who achieve a satisfactory sedation depth (MOAA/S score ≤ 1) without the need for rescue sedative medications. |
Contacts
CONTACTLing long Gong, PhD
Outcome results
None listed