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

NCT07456111 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-03-06

No results posted yet for this study

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 undergoing colonoscopic polypectomies in procedural sedation using remimazolam besylate/sufentanyl are circulatory and respiratory as or more stable when compared with propofol/sufentanyl sedation.

Conditions

  • Colonic Polyp
  • Sedation Complication

Interventions

DRUG

Remimazolam besylate

The patient will receive the intravenous opioid analgesic sufentanyl 0.2 mcg/kg over a period of 30 seconds. After 1 to 2 minutes the patient will receive remimazolam besylate intravenously in a dose of 5.0 mg over a period of 1 minute. After two minutes, a maintenance dose of 2.5 mg will be administered using the titration method over a period of 15 seconds until the desired sedation effect is achieved.The maximum intravenous dose of administered remimazolam besylate will be 33 mg.BIS monitoring and a modified MOAA/S scale will be used to assess the depth of sedation. The first measurement of the depth of sedation will be initially following the complete administration of the sedative remimazolam besylate and will serve as the initial/starting point. Afterwards, a measurement of the MOAA/S scale will be performed every 30 seconds for a total of 3 minutes. The most desirable level of sedation for the planned procedure is defined as a MOAA/S measurement of \<3.

DRUG

Propofol

The patient will be given intravenous opiod analgesia sufentanyl 0,2 mg/kg.within 30 seconds. After approximately 1-2 minutes the patient will receive the titrated anestetic propofol intravenously at a dose of 1,5 to 2,5 mg/kg (20,0 mg. propofol evry 10 seconds). In elderly patients and patients with ASA grade III, the total dose of propofol will be least 1 mg/kg with an administration rate of 10 every 10 seconds.

Sponsors & Collaborators

  • Clinical Hospital Centre Zagreb

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2027-11-30
Completion
2028-12-30

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07456111 on ClinicalTrials.gov