Remimazolam Combined With Oliceridine for Sedation in Elderly Patients Undergoing Gastrointestinal Endoscopy (RMZ-OLI-ENDO)

Hemodynamic and Oxygenation Profiles of Remimazolam Combined With Oliceridine Versus Sufentanil in Elderly Patients Undergoing Painless Gastrointestinal Endoscopy: A Randomized, Double-blind, Controlled 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sedation; Gastrointestinal Endoscopy
• Intervention / Treatment: Drug: Remimazolam Tosilate for Injection; Drug: Oliceridine Fumarate

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.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ling long Gong, PhD; Phone Number: +86-17317107780; Email: 350552970@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Remimazolam Tosilate for Injection; 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.; Other Names: Remimazolam; Remimazolam Tosilate; Drug: Oliceridine Fumarate; Administered intravenously before or during the procedure to provide stable analgesic cooperation and optimize procedural sedation quality in elderly patients.; Other Names: Oliceridine
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.	Drug: Remimazolam Tosilate for Injection; 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.; Other Names: Remimazolam; Remimazolam Tosilate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypoxemia	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.	From initiation of sedation induction to completion of the gastrointestinal endoscopic procedure, approximately 30 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Hypotension	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.	From the pre-induction baseline assessment to transfer to the post-anesthesia care unit, up to 1 hour.
Sedation success rate	The proportion of patients who achieve a satisfactory sedation depth (MOAA/S score ≤ 1) without the need for rescue sedative medications.	From the start of sedation induction to the completion of the endoscopic procedure

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): July 5, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 5, 2026
• First Submitted That Met QC Criteria: July 11, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 11, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Older Adults; Remimazolam; Hypoxemia; Procedural Sedation; Oliceridine; Painless Gastrointestinal Endoscopy
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypoxia; Therapeutics; Drug Administration Routes; Drug Therapy; Injections; remimazolam; ((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine
• Other Study ID Numbers: 2025-E-58 (Other Grant/Funding Number: Shanghai Baoshan District Science and Technology Commission)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to the inclusion of sensitive clinical and private information of elderly patients, full individual participant data (IPD) cannot be made publicly available as it was not explicitly authorized in the patient informed consent. To protect patient privacy and ensuring data security, the raw IPD will not be shared on public platforms. De-identified data may be available from the corresponding author upon reasonable academic request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No