SedationRMZ-OLI-ENDONCT07707258

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

A study testing Remimazolam Tosilate for Injection and Oliceridine Fumarate in people with Sedation and Gastrointestinal Endoscopy, run by Baoshan Branch, Renji Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 65 to 80 years
Conditions the study is for: Sedation, Gastrointestinal Endoscopy
What is being tested?: Remimazolam Tosilate for Injection and Oliceridine Fumarate
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 1 siteChina
Study dates: 17 Jul 2026to 30 Aug 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 to 80 years
All sexes
No healthy volunteers
Older adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Baoshan District Dachang Hospital (Renji Hospital Baoshan Branch)
Shanghai, Shanghai Municipality, 200444

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions: Sedation, Gastrointestinal Endoscopy
Being tested: Remimazolam Tosilate for Injection, Oliceridine Fumarate
Keywords: Remimazolam, Oliceridine, Older Adults, Painless Gastrointestinal Endoscopy, Procedural Sedation, Hypoxemia
Medical subject headings: Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Remimazolam Tosilate for InjectionDrug
Also called Remimazolam Tosilate, Remimazolam
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.
Oliceridine FumarateDrug
Also called Oliceridine
Administered intravenously before or during the procedure to provide stable analgesic cooperation and optimize procedural sedation quality in elderly patients.

Study groups in NCT07707258
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Remimazolam Tosilate for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From initiation of sedation induction to completion of the gastrointestinal endoscopic procedure, approximately 30 minutes.

Secondary outcomes (2)

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.
Measured: 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.
Measured: From the start of sedation induction to the completion of the endoscopic procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jul 202630 Aug 2026

First posted16 Jul 2026
Study start17 Jul 2026
Primary completion30 Aug 2026
Study completion30 Aug 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SedationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Patients are randomly assigned to different sedation protocol groups in a parallel manner.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07707258
Sponsor's protocol ID: 2025-E-58
Other IDs: 2025-E-58
Acronym: RMZ-OLI-ENDO
Status last verified: Oct 2026
First submitted: 5 Jul 2026
Last updated: 3 Nov 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sedation trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hemodynamic and Oxygenation Profiles of Remimazolam Combined With Oliceridine Versus Sufentanil in Elderly Patients Undergoing Painless Gastrointestinal Endoscopy: A Randomized, Double-blind, Controlled Trial
ClinicalTrials.gov ID: NCT07707258
Acronym / sponsor ID: RMZ-OLI-ENDO / 2025-E-58
Conditions: Sedation, Gastrointestinal Endoscopy
Keywords: Remimazolam, Oliceridine, Older Adults, Painless Gastrointestinal Endoscopy, Procedural Sedation, Hypoxemia
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Baoshan Branch, Renji Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
Study start: 17 Jul 2026 (actual)
Primary completion: 30 Aug 2026 (actual)
Study completion: 30 Aug 2026 (actual)
First posted: 16 Jul 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: Patients are randomly assigned to different sedation protocol groups in a parallel manner.

Arm	Type	Receives
Remimazolam + Oliceridine Group	Experimental	Drug: Remimazolam Tosilate for Injection, Drug: Oliceridine FumaratePatients 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.
Active Control Group	Active comparator	Drug: Remimazolam Tosilate for InjectionPatients 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.

Who may qualify

Ages: 65 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Remimazolam Tosilate for InjectionAlso: Remimazolam Tosilate, RemimazolamAdministered intravenously for sedation induction and maintenance during gastrointestinal endoscopy. The dosage will be titrated according to the patient's sedation depth and clinical response.	Drug	Active Control Group, Remimazolam + Oliceridine Group
Oliceridine FumarateAlso: OliceridineAdministered intravenously before or during the procedure to provide stable analgesic cooperation and optimize procedural sedation quality in elderly patients.	Drug	Remimazolam + Oliceridine Group

Primary outcome

Incidence of hypoxemia
Time frame: 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.

2 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
Individual participant dataSharing planned: No. 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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Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 3
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Weighted Blankets for Agitation in Adults in the Intensive Care Unit
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The Danish Out-of-Hospital Cardiac Arrest Study
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Media Use, Anxiety, Sedation, and Recovery in Children Having Upper GI Endoscopy
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of hypoxemia (time frame: From initiation of sedation induction to completion of the gastrointestinal endoscopic procedure, approximately 30 minutes.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07707258.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.