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

NCT07707258 | Recruiting

• 1 other identifier: 2025-E-58
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation; Gastrointestinal Endoscopy

Keywords

Remimazolam; Oliceridine; Older Adults; Painless Gastrointestinal Endoscopy; Procedural Sedation; Hypoxemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of Hypotension

  From the pre-induction baseline assessment to transfer to the post-anesthesia care unit, up to 1 hour.

• Sedation success rate

  From the start of sedation induction to the completion of the endoscopic procedure

Study Arms (2)

Remimazolam + Oliceridine Group

EXPERIMENTAL

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; Drug: Oliceridine Fumarate

Active Control Group

ACTIVE COMPARATOR

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

Interventions

Remimazolam Tosilate for Injection DRUG

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.

Also known as: Remimazolam Tosilate, Remimazolam

Active Control Group; Remimazolam + Oliceridine Group

Oliceridine Fumarate DRUG

Administered intravenously before or during the procedure to provide stable analgesic cooperation and optimize procedural sedation quality in elderly patients.

Also known as: Oliceridine

Remimazolam + Oliceridine Group

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Baoshan District Dachang Hospital (Renji Hospital Baoshan Branch)

Shanghai, Shanghai Municipality, 200444, China

RECRUITING

MeSH Terms

Conditions

Hypoxia

Interventions

Injections; remimazolam; ((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Ling long Gong, PhD

CONTACT

+86-17317107780; 350552970@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients are randomly assigned to different sedation protocol groups in a parallel manner.

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: July 16, 2026
• Study Start: July 17, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)