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

11. juli 2026 opdateret af: Baoshan Branch, Renji Hospital, Shanghai Jiao Tong University School of Medicine

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

240

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Ling long Gong, PhD
  • Telefonnummer: +86-17317107780
  • E-mail: 350552970@qq.com

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.
Andre navne:
  • Remimazolam
  • Remimazolam Tosilate
Medicin: Oliceridine Fumarate
Administered intravenously before or during the procedure to provide stable analgesic cooperation and optimize procedural sedation quality in elderly patients.
Andre navne:
  • Oliceridine
Aktiv komparator: 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.
Medicin: 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.
Andre navne:
  • Remimazolam
  • Remimazolam Tosilate

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of hypoxemia
Tidsramme: 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.
From initiation of sedation induction to completion of the gastrointestinal endoscopic procedure, approximately 30 minutes.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Hypotension
Tidsramme: 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.
From the pre-induction baseline assessment to transfer to the post-anesthesia care unit, up to 1 hour.
Sedation success rate
Tidsramme: 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.
From the start of sedation induction to the completion of the endoscopic procedure

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

5. juli 2026

Primær færdiggørelse (Anslået)

1. september 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

5. juli 2026

Først indsendt, der opfyldte QC-kriterier

11. juli 2026

Først opslået (Faktiske)

16. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025-E-58 (Andet bevillings-/finansieringsnummer: Shanghai Baoshan District Science and Technology Commission)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

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Kliniske forsøg med Sedation

Kliniske forsøg med Remimazolam Tosilate for Injection

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