Remimazolam Combined With Oliceridine for Sedation in Elderly Patients Undergoing Gastrointestinal Endoscopy (RMZ-OLI-ENDO)
17. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
240
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ling long Gong, PhD
- Telefonnummer: +86-17317107780
- E-post: 350552970@qq.com
Studiesteder
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200444
- Rekruttering
- Shanghai Baoshan District Dachang Hospital (Renji Hospital Baoshan Branch)
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Ta kontakt med:
- Linglong Gong, MD
- Telefonnummer: +86-17317107780
- E-post: 17317107780@163.com
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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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 navn:
Administered intravenously before or during the procedure to provide stable analgesic cooperation and optimize procedural sedation quality in elderly patients.
Andre navn:
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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.
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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 navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of hypoxemia
Tidsramme: From initiation of sedation induction to completion of the gastrointestinal endoscopic procedure, approximately 30 minutes.
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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.
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From initiation of sedation induction to completion of the gastrointestinal endoscopic procedure, approximately 30 minutes.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of Hypotension
Tidsramme: From the pre-induction baseline assessment to transfer to the post-anesthesia care unit, up to 1 hour.
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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.
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From the pre-induction baseline assessment to transfer to the post-anesthesia care unit, up to 1 hour.
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Sedation success rate
Tidsramme: From the start of sedation induction to the completion of the endoscopic procedure
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The proportion of patients who achieve a satisfactory sedation depth (MOAA/S score ≤ 1) without the need for rescue sedative medications.
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From the start of sedation induction to the completion of the endoscopic procedure
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
17. juli 2026
Primær fullføring (Antatt)
1. september 2026
Studiet fullført (Antatt)
1. desember 2026
Datoer for studieregistrering
Først innsendt
5. juli 2026
Først innsendt som oppfylte QC-kriteriene
11. juli 2026
Først lagt ut (Faktiske)
16. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025-E-58 (Annet stipend/finansieringsnummer: Shanghai Baoshan District Science and Technology Commission)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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