BridgeMD
New treatment option for Sedation
Official title Remimazolam Combined With Oliceridine for Sedation in Elderly Patients Undergoing Gastrointestinal Endoscopy
ClinicalTrials.gov ID: NCT07707258
What this study is testing
What is Remimazolam Tosilate for Injection?
Remimazolam Tosilate for Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sedation.
Also referred to as Remimazolam Tosilate, Remimazolam.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 to 80
You may be able to join 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...
- Fried frailty phenotype score \< 3.
You likely can't join 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.
See the full eligibility 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...
- Fried frailty phenotype score \< 3.
- Mini-Mental State Examination (MMSE) score ≥ 27.
- Provision of written informed consent by the patient or legal representative.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.