A Comparison of Remimazolam Besylate and Propofol Sedation in Patients Undergoing Colonoscopic Polypectomy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorClinical Hospital Centre Zagreb
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Remimazolam besylate
DrugThe 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.
Propofol
DrugThe 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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Remimazolam besylatExperimental treatment 1 intervention
Group B: PropofolActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hemodynamic Stability - Mean Arterial Pressure (MAP)
Mean arterial pressure (mmHg) measured at multiple timepoints to assess overall circulatory stability. Comparison of MAP values between remimazolam and propofol groups.
Time frame
from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.2
Hemodynamic Stability - Systolic and Diastolic Blood Pressure
Systolic and diastolic blood pressure (mmHg) measured at multiple timepoints to assess circulatory stability. Comparison between remimazolam and propofol groups.
Time frame
from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.3
Hemodynamic Stability - Heart Rate
Heart rate (beats per minute) measured continuously via ECG monitoring. Comparison of heart rate values between study groups.
Time frame
from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.4
Incidence of Hypotension
Percentage of participants experiencing hypotension defined as either: Decrease in systolic blood pressure ≥20% from baseline value (measured before remimazolam or propofol administration), OR Mean arterial pressure (MAP) ≤60 mmHg during procedural sedation
Time frame
from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.Secondary outcomes
1
Procedural Sedation Success Rate
Percentage of participants achieving successful sedation defined as: Completion of entire endoscopic polypectomy procedure, AND No need for rescue sedation (defined as propofol 1.5-2.5 mg/kg IV by titration for inadequate sedation level in either group), AND Maximum of 5 additional drug doses within 15 minutes of initial dose
Time frame
During the endoscopic procedure (estimated 30-50 minutes2
Time to Adequate Sedation Level
Time in minutes from first drug dose to achievement of adequate sedation level, defined as MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score \<3 AND/OR BIS (Bispectral Index) value 50-70
Time frame
From first drug administration until adequate sedation achieved (estimated 1-5 minutes)3
Time to Full Alertness
Time in minutes from last drug dose to full patient alertness, defined as achieving MOAA/S score of 5
Time frame
From last drug administration until full alertness (estimated 10-20 minutes post-procedure)4
Time to Recovery Room Discharge Readiness
Time in minutes from last drug dose to patient meeting discharge criteria from recovery room using Modified Aldrete Scoring System
Time frame
From last drug administration until meeting discharge criteria (estimated 15-30 minutes post-procedure)Sponsors and contacts
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Source ClinicalTrials.gov