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New sedation cocktail aims to protect elderly patients during routine scopes

NCT ID NCT07707258

Symptom relief Sponsor: Baoshan Branch, Renji Hospital, Shanghai Jiao Tong University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 16, 2026 · Last updated Jul 22, 2026 · Updated 3 times

Summary

This trial investigates whether combining two drugs, remimazolam and oliceridine, can provide safer sedation for elderly patients (ages 65-80) undergoing painless gastrointestinal endoscopy. The goal is to maintain stable breathing and blood pressure while reducing risks like low oxygen levels and cognitive changes after the procedure. Participants will be randomly assigned to receive either the new combination or the standard sedative sufentanil, and their vital signs will be closely monitored.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
remimazolam combined with oliceridine
What this could lead to
If successful, this could lead to a safer sedation option for elderly patients undergoing gastrointestinal endoscopy, with fewer breathing and blood pressure complications.
What could go wrong
This is a small, early-stage trial, so results may not apply to all elderly patients. The combination might still cause side effects like low oxygen or blood pressure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Hypoxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastrointestinal endoscopy Sedation

How to take part

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  1. The places running it

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  2. The official record

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    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Shanghai Baoshan District Dachang Hospital (Renji Hospital Baoshan Branch)

    RECRUITING

    Shanghai, Shanghai Municipality, 200444, China

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