Status:

RECRUITING

A Comparison of Remimazolam Besylate and Propofol Sedation in Patients Undergoing Colonoscopic Polypectomy

Lead Sponsor:

Clinical Hospital Centre Zagreb

Conditions:

Colonic Polyp

Sedation Complication

Eligibility:

All Genders

18-60 years

Phase:

PHASE4

Brief Summary

The goal of this prospective, randomized, controlled study is to compare remimazolam besilat/sufentanyl and propofol/sufentanyl in patients during colonoscopic polypectomies procedures. Patients unde...

Detailed Description

Following the approval for the research by the Ethics Committee (Clinical Hospital Center, Zagreb, Croatia), a total of ninety (90) patients will be included in the research. Forty five (45) patients ...

Eligibility Criteria

Inclusion 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.

Exclusion Criteria:

  • 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.

Key Trial Info

Start Date :

January 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 30 2028

Estimated Enrollment :

90 Patients enrolled

Trial Details

Trial ID

NCT07456111

Start Date

January 1 2025

End Date

December 30 2028

Last Update

March 6 2026

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

UHC Zagreb

Zagreb, Croatia, 10000