BridgeMD
New treatment option for Colonic Polyp
Official title A Comparison of Remimazolam Besylate and Propofol Sedation in Patients Undergoing Colonoscopic Polypectomy
ClinicalTrials.gov ID: NCT07456111
What this study is testing
What is Remimazolam besylate?
Remimazolam besylate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colonic polyp.
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
- The goal of this prospective, randomized, controlled study is to compare remimazolam besilat/sufentanyl and propofol/sufentanyl in patients during colonoscopic polypectomies procedures. Patients undergoing colonoscopic polypectomies in procedural sedation using remimazolam besylate/sufentanyl are circulatory and respiratory as or more stable when compared with propofol/sufentanyl sedation.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Patients both male and female
- ages 18 to 60 years,
- with one or more colonic polyps confirmed by colonoscopy and scheduled for a colonoscopy and polypectomy
- The duration of the colonoscopy ranges from 30 to 50 minutes.
- ASA status (American Society of Anaesthesiologists physical status) I-III.
You likely can't join if
- Patients aged \>60 years
- ASA status IV-V,
- BMI \>29.9 kg/m2,
- a high risk of vomiting, regurgitation and/or aspiration of gastric contents.
- Patients with:
- uncontrolled hypertension (systolic pressure \>160 mmHg),
See the full eligibility criteria
- Patients both male and female
- ages 18 to 60 years,
- with one or more colonic polyps confirmed by colonoscopy and scheduled for a colonoscopy and polypectomy
- The duration of the colonoscopy ranges from 30 to 50 minutes.
- ASA status (American Society of Anaesthesiologists physical status) I-III.
- BMI (Body mass index) 18.5-29.9 kg/m2.
- Only patients who signed an informed consent waiver and consented to participate in the research study.
- Patients aged \>60 years
- ASA status IV-V,
- BMI \>29.9 kg/m2,
- a high risk of vomiting, regurgitation and/or aspiration of gastric contents.
- Patients with:
- uncontrolled hypertension (systolic pressure \>160 mmHg),
- heart disease (cardiomyopathy, cardiac-rhythm disorder, left ventricular ejection fraction \<45%, stenosis or heart valve insufficiency and coronary heart disease)
- lung disease (pneumonia, chronic obstructive pulmonary disease, asthma and pulmonary tumors),
- kidney diseases (kidney failure, GF 30/59 ml/min/1.73m2),
- liver diseases,
- coagulation disorders
- lymphatic tissue diseases
- extended malignant disease.
- History of allergy on nutritional allergens including soy bean, benzodiazepines, propofol or opioids.
- Patients who currently use analgesic medications or other psycho-pharmaceuticals.
- History of illicit drug use.
- Children, pregnant and nursing women.
- Alcohol dependency.
- Patients involved in other clinical research studies,
- patients who refused to take part in the research or have not signed the written informed consent form.
The study team makes the final eligibility decision.
Where it's taking place
- Zagreb, Croatia
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, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zagreb, Croatia. 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.