Colonic PolypPhase 4ByproNCT07456111
A Comparison of Remimazolam Besylate and Propofol Sedation in Patients Undergoing Colonoscopic Polypectomy
A Phase 4 study testing Remimazolam besylate and Propofol in people with Colonic Polyp and Sedation Complication, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.
Trial summary
The goal of this prospective, randomized, controlled study is to compare remimazolam besilat/sufentanyl and propofol/sufentanyl in patients during colonoscopic polypectomies procedures. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Colonic Polyp, Sedation Complication
- What is being tested?
- Remimazolam besylate and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Jan 2025to 30 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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),
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site, 1 recruiting
- Recruiting
UHC Zagreb
Zagreb, 10000
Željko Drvar, MD, PhD, 003851 2388 888, zeljko.drvar@kbc-zagreb.hr
Željko Drvar, MD, PhD
About this study
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.
Read the 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 will be assigned to the study group (SG) and forty five (45) patients to the control group (CG).
Research Goals:
Primary goals
- Observe and compare circulatory and respiratory stability in patients undergoing procedural sedation with either remimazolam besylate or propofol during colonoscopic polypectomies
- Define and compare the incidence of hypotension between the study grou and the control group.
- Define and compare the incidence of respiratory depression between the study group and the control group.
Secondary goals
- Define and compare the success of remimazolam besylate sedation compared with propofol.
- Define and compare the time required to achieve adequate sedation between the two observed groups.
- Define and compare the time to achieve full consciousness between the two observed groups.
- Define and compare the time to complete recovery between the two groups.
Patients from both groups, upon arrival to the gastroenterology ward will have a peripheral venous line installed by puncturing one of the veins on the dorsum of the hand or forearm. The veins of choice include the rete venosum dorsale manus, vena cephalica and vena basilica, and an 18 G or 20 G intravenous cannula will be placed. After confirming the functionality of the venous line, the intravenous administration of Fifty will follow. The infusion rate will depend on the patient's BMI and circulatory status.
Study Group (SG):
A total of 45 patients are included in this group. After non-invasive monitoring, positioning the patient in the left lateral position and placing a nasal catheter with a continuous oxygen flow of 3 l/min, 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 (Modified Observers Assessment of Alertness and Sedation Scale) 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.
Control group (CG)
A total of 45 patients will be included in this group.
Firstly, non-invasive monitoring will be applied to the patient, then they will be placed in the left lateral position and through a nasal catheter a continuous oxygen flow of 3l/min will be administered. The patient will be given intravenous opioid analgesia Sufentanyl 0.2 mg/kg. within 30 seconds. After approximately 1-2 minutes the patient will receive the titrated anesthetic propofol intravenously at a dose of 1.5 to 2.5 mg/kg, (20.0 to 30.0 mg propofol every 10 seconds). In elderly patients and patients with ASA grade III, the total dose of propofol will be at least 1 mg/kg with an administration rate of 10.0 to 20.0 mg every 10 seconds.
Sedation will be maintained using propofol in a continuous intravenous infusion. The maintenance dose given will be 0.5 to 1.0 mg propofol/kg/hour.
BIS monitoring and a modified MOAA/S (Modified Observers Assessment of Alertness and Sedation Scale) scale will be used to assess the depth of sedation. The first measurement of the MOAA/S score will be conducted after the total intravenous propofol dose was administered and this first measurement will be considered the starting/zero measurement. MOAA/S scale point will be measured every 30 seconds for a total of 3 minutes. A measurement of <3 points will be considered the most desirable level of sedation for the planned procedure.
In both study groups the following parameters will continuously be measured:
- Pulse oxymetry (SpO2), respiratory rate (RR), EKG, heart rate (HR) and rhythm, systolic, diastolic and mean arterial pressure.
- Circulatory parameters including systolic, diastolic and mean arterial pressure will be measured:
Primary measurement:
Upon patients' arrival to the pre-op room (first measurement) and 5 minutes before proceeding to the operating theater.
During the procedure:
Before administering the sedative remimazolam besylate or propofol and at 3, 5, 10, and 15 minutes. (every 5 minutes during the procedure) until the patient is consciousness, followed by the first of five sets of MOAAS/S measurements upon completion of the procedure or when the last dose of medication is given.
Frequency of hypotension in both groups of patients and comparing the results between the SG and CG.
Hypotension during the procedure using sedation or propofol is defined as:
a decrease in systolic systemic pressure of 20% or more compared with the first measurement before the administration of remimazolam besylata or propofol.
A mean arterial pressure of ≤60 mmHg during while the patient is under sedation.
- Sinus bradycardia is defined as a decreased cardiac rate. 5. The frequency of respiratory depression compared between the two groups, SG and CG.
Respiratory depression during sedation is defined as:
Respiratory rate of <8 breaths per minute and/or a peripheral blood oxygen percentage of (SpO2) <90.
- BIS monitoring. 7. The success of procedural sedation using remimazolam besylate and sedation using propofol:
Will be shown as the percentage of successfully sedated patients defined as:
The completion of endoscopic polypectomy, without the need for rapid/fast acting emergency sedation or a maximum number of 5 additional doses given withing 15 minutes of the first dose to maintain adequate sedation.
- The time to achieve adequate sedation is defined as the time from administering the first dose of medication until achieving <3 points on the MOAA/S scale and/ora BIS.
- The time to achieve full consciousness is defined as the time since the administration of the last dose of medication until the patient is fully aware, or until the patients has 5 points on the MOAA/S scale.
- The time needed for the patient to fully recover after the procedure in both groups is defined by the criteria for patient dismissal using the - Modified Aldrete score scale.
The total volume of the given crystalloid solution (Plasma-lyte) will be measured in both groups.
- Conditions
- Colonic Polyp, Sedation Complication
- Being tested
- Remimazolam besylate, Propofol
- Keywords
- Remimazolam besylate, Propofol, Procedural sedation, Polypectomy, Circulatory stability, Respiratory stability, Respiratory depression
- Medical subject headings
- Colonic Polyps, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam besylateDrug
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.
PropofolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam besylat | Experimental | Not described Receives: Drug: Remimazolam besylate |
| Propofol | Active comparator | Not described Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.
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.
Measured: from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.
Hemodynamic Stability - Heart Rate
Heart rate (beats per minute) measured continuously via ECG monitoring. Comparison of heart rate values between study groups.
Measured: from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.
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
Measured: from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.
Incidence of Bradycardia
Bradycardia is defined as a heart rate (HR) below 50 beats per minute (bpm), or a clinically significant decrease in HR of ≥20% from the pre-induction baseline, sustained for ≥1 minute and/or requiring pharmacological or non-pharmacological intervention (e.g., atropine administration, reduction or discontinuation of the study drug).
HR will be continuously monitored via standard intraoperative ECG monitoring and recorded at predefined time points: baseline (pre-induction), immediately post-induction (T1), at 5-minute intervals intraoperatively, at emergence from anesthesia, and at 15 and 30 minutes postoperatively in the post-anesthesia care unit (PACU).
The incidence of bradycardia will be expressed as the proportion of patients experiencing at least one episode meeting the above criteria within the defined observation window.
Measured: from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.
Respiratory Stability - Oxygen Saturation (SpO₂)
Peripheral oxygen saturation (%) measured continuously via pulse oximetry. Comparison of SpO₂ values between study groups.
Measured: from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.
Incidence of Respiratory Depression
Percentage of participants experiencing respiratory depression defined as:
Respiratory rate <8 breaths per minute, AND/OR Peripheral oxygen saturation (SpO₂) <90%
Measured: from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.
Secondary outcomes (11)
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
Measured: During the endoscopic procedure (estimated 30-50 minutes
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
Measured: From first drug administration until adequate sedation achieved (estimated 1-5 minutes)
Time to Full Alertness
Time in minutes from last drug dose to full patient alertness, defined as achieving MOAA/S score of 5
Measured: From last drug administration until full alertness (estimated 10-20 minutes post-procedure)
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
Measured: From last drug administration until meeting discharge criteria (estimated 15-30 minutes post-procedure)
Depth of Sedation - BIS Values
Bispectral Index (BIS) values (0-100 scale) measured continuously to assess depth of sedation. Target range 50-70. Comparison of BIS values between study groups throughout procedure.
Measured: From baseline through procedure completion until full alertness (estimated 30-60 minutes)
Depth of Sedation - MOAA/S Scores
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores (0-5 scale) measured at baseline, after total drug dose (time zero), then every 30 seconds for 3 minutes. Target score <3 for adequate sedation.
Measured: Baseline, immediately after drug administration, then every 30 seconds for 3 minutes, then as clinically indicated during procedure
Total Drug Dosage
Total dose of remimazolam besilate (mg) administered during procedure in the intervention group and total dose of propofol (mg) administered during procedure in the control group. Total dose of sufentanil (micrograms) administered in both groups (0.2 mcg/kg initial dose)
Measured: During procedure (estimated 30-50 minutes)
Procedure and sedation duration
Duration of sedation and colonoscopic polypectomy procedure in minutes
Measured: From first drug administration to full alertness (estimated 30-60 minutes) From procedure start to procedure completion (estimated 30-50 minutes)
Total Crystalloid Infusion Volume
Total volume (mL) of Plasma-Lyte crystalloid solution administered during procedure
Measured: During procedure and recovery (estimated 30-90 minutes)
Incidence of Post-Procedure Pain, nausea and vomiting
Percentage of participants experiencing pain, nausea or vomiting in the post-procedure period
Measured: ost-procedure assessment before recovery room discharge (estimated 30-60 minutes after last drug dose)
Satisfaction Score
Patient-reported satisfaction with sedation procedure (VAS from 0-10) Endoscopist-reported satisfaction with sedation quality for procedure performance (VAS from 0-10)
Measured: Post-procedure before recovery room discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Jan 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Colonic PolypStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparation of two drug grups in controlled medical environment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Centre Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Željko Drvar, Clinical Hospital Centre Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456111
- Sponsor's protocol ID
- LOC-100018379
- Acronym
- Bypro
- Status last verified
- Mar 2026
- First submitted
- 12 Jan 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will not be shared due to regulatory, ethical, and practical constraints. Croatian healthcare data protection law (NN 14/19) and GDPR regulations mandate strict safeguarding of personal health information. The informed consent obtained from participants explicitly limits data use to this specific study and does not authorize sharing of individual-level data with external parties. Given the relatively small sample size (n=100) and the specific clinical context at a single tertiary center, there is meaningful risk of participant re-identification even with standard de-identification procedures. Additionally, our institution lacks the technical infrastructure for secure data repository management and controlled access mechanisms necessary for responsible IPD sharing. Resources for comprehensive data curation, security auditing, and long-term stewardship were not included in the study budget. However, we are committed to research transparency.
Publications
Zhu X, Wang H, Yuan S, Li Y, Jia Y, Zhang Z, Yan F, Wang Z. Efficacy and Safety of Remimazolam in Endoscopic Sedation-A Systematic Review and Meta-Analysis. Front Med (Lausanne). 2021 Jul 26;8:655042. doi: 10.3389/fmed.2021.655042. eCollection 2021.
PubMed 34381792Qiu Y, Gu W, Zhao M, Zhang Y, Wu J. The hemodynamic stability of remimazolam compared with propofol in patients undergoing endoscopic submucosal dissection: A randomized trial. Front Med (Lausanne). 2022 Aug 8;9:938940. doi: 10.3389/fmed.2022.938940. eCollection 2022.
PubMed 36004376Guo J, Qian Y, Zhang X, Han S, Shi Q, Xu J. Remimazolam tosilate compared with propofol for gastrointestinal endoscopy in elderly patients: a prospective, randomized and controlled study. BMC Anesthesiol. 2022 Jun 10;22(1):180. doi: 10.1186/s12871-022-01713-6.
PubMed 35689208Xin Y, Chu T, Wang J, Xu A. Sedative effect of remimazolam combined with alfentanil in colonoscopic polypectomy: a prospective, randomized, controlled clinical trial. BMC Anesthesiol. 2022 Aug 16;22(1):262. doi: 10.1186/s12871-022-01805-3.
PubMed 35974309Chen SH, Yuan TM, Zhang J, Bai H, Tian M, Pan CX, Bao HG, Jin XJ, Ji FH, Zhong TD, Wang Q, Lv JR, Wang S, Li YJ, Yu YH, Luo AL, Li XK, Min S, Li L, Zou XH, Huang YG. Remimazolam tosilate in upper gastrointestinal endoscopy: A multicenter, randomized, non-inferiority, phase III trial. J Gastroenterol Hepatol. 2021 Feb;36(2):474-481. doi: 10.1111/jgh.15188. Epub 2020 Jul 24.
PubMed 32677707Dossa F, Megetto O, Yakubu M, Zhang DDQ, Baxter NN. Sedation practices for routine gastrointestinal endoscopy: a systematic review of recommendations. BMC Gastroenterol. 2021 Jan 7;21(1):22. doi: 10.1186/s12876-020-01561-z.
PubMed 33413147Sahinovic MM, Struys MMRF, Absalom AR. Clinical Pharmacokinetics and Pharmacodynamics of Propofol. Clin Pharmacokinet. 2018 Dec;57(12):1539-1558. doi: 10.1007/s40262-018-0672-3.
PubMed 30019172Borkett KM, Riff DS, Schwartz HI, Winkle PJ, Pambianco DJ, Lees JP, Wilhelm-Ogunbiyi K. A Phase IIa, randomized, double-blind study of remimazolam (CNS 7056) versus midazolam for sedation in upper gastrointestinal endoscopy. Anesth Analg. 2015 Apr;120(4):771-80. doi: 10.1213/ANE.0000000000000548.
PubMed 25502841Rex DK, Bhandari R, Desta T, DeMicco MP, Schaeffer C, Etzkorn K, Barish CF, Pruitt R, Cash BD, Quirk D, Tiongco F, Sullivan S, Bernstein D. A phase III study evaluating the efficacy and safety of remimazolam (CNS 7056) compared with placebo and midazolam in patients undergoing colonoscopy. Gastrointest Endosc. 2018 Sep;88(3):427-437.e6. doi: 10.1016/j.gie.2018.04.2351. Epub 2018 Apr 30.
PubMed 29723512Kim KM. Remimazolam: pharmacological characteristics and clinical applications in anesthesiology. Anesth Pain Med (Seoul). 2022 Jan;17(1):1-11. doi: 10.17085/apm.21115. Epub 2022 Jan 20.
PubMed 35139608Hinkelbein J, Lamperti M, Akeson J, Santos J, Costa J, De Robertis E, Longrois D, Novak-Jankovic V, Petrini F, Struys MMRF, Veyckemans F, Fuchs-Buder T, Fitzgerald R. European Society of Anaesthesiology and European Board of Anaesthesiology guidelines for procedural sedation and analgesia in adults. Eur J Anaesthesiol. 2018 Jan;35(1):6-24. doi: 10.1097/EJA.0000000000000683.
PubMed 28877145
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Remimazolam Besylate and Propofol Sedation in Patients Undergoing Colonoscopic Polypectomy
- ClinicalTrials.gov ID
- NCT07456111
- Acronym / sponsor ID
- Bypro / LOC-100018379
- Conditions
- Colonic Polyp, Sedation Complication
- Keywords
- Remimazolam besylate, Propofol, Procedural sedation, Polypectomy, Circulatory stability, Respiratory stability, Respiratory depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Clinical Hospital Centre ZagrebUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 will be assigned to the study group (SG) and forty five (45) patients to the control group (CG).
Research Goals:
Primary goals
- Observe and compare circulatory and respiratory stability in patients undergoing procedural sedation with either remimazolam besylate or propofol during colonoscopic polypectomies
- Define and compare the incidence of hypotension between the study grou and the control group.
- Define and compare the incidence of respiratory depression between the study group and the control group.
Secondary goals
- Define and compare the success of remimazolam besylate sedation compared with propofol.
- Define and compare the time required to achieve adequate sedation between the two observed groups.
- Define and compare the time to achieve full consciousness between the two observed groups.
- Define and compare the time to complete recovery between the two groups.
Patients from both groups, upon arrival to the gastroenterology ward will have a peripheral venous line installed by puncturing one of the veins on the dorsum of the hand or forearm. The veins of choice include the rete venosum dorsale manus, vena cephalica and vena basilica, and an 18 G or 20 G intravenous cannula will be placed. After confirming the functionality of the venous line, the intravenous administration of Fifty will follow. The infusion rate will depend on the patient's BMI and circulatory status.
Study Group (SG):
A total of 45 patients are included in this group. After non-invasive monitoring, positioning the patient in the left lateral position and placing a nasal catheter with a continuous oxygen flow of 3 l/min, 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 (Modified Observers Assessment of Alertness and Sedation Scale) 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.
Control group (CG)
A total of 45 patients will be included in this group.
Firstly, non-invasive monitoring will be applied to the patient, then they will be placed in the left lateral position and through a nasal catheter a continuous oxygen flow of 3l/min will be administered. The patient will be given intravenous opioid analgesia Sufentanyl 0.2 mg/kg. within 30 seconds. After approximately 1-2 minutes the patient will receive the titrated anesthetic propofol intravenously at a dose of 1.5 to 2.5 mg/kg, (20.0 to 30.0 mg propofol every 10 seconds). In elderly patients and patients with ASA grade III, the total dose of propofol will be at least 1 mg/kg with an administration rate of 10.0 to 20.0 mg every 10 seconds.
Sedation will be maintained using propofol in a continuous intravenous infusion. The maintenance dose given will be 0.5 to 1.0 mg propofol/kg/hour.
BIS monitoring and a modified MOAA/S (Modified Observers Assessment of Alertness and Sedation Scale) scale will be used to assess the depth of sedation. The first measurement of the MOAA/S score will be conducted after the total intravenous propofol dose was administered and this first measurement will be considered the starting/zero measurement. MOAA/S scale point will be measured every 30 seconds for a total of 3 minutes. A measurement of <3 points will be considered the most desirable level of sedation for the planned procedure.
In both study groups the following parameters will continuously be measured:
- Pulse oxymetry (SpO2), respiratory rate (RR), EKG, heart rate (HR) and rhythm, systolic, diastolic and mean arterial pressure.
- Circulatory parameters including systolic, diastolic and mean arterial pressure will be measured:
Primary measurement:
Upon patients' arrival to the pre-op room (first measurement) and 5 minutes before proceeding to the operating theater.
During the procedure:
Before administering the sedative remimazolam besylate or propofol and at 3, 5, 10, and 15 minutes. (every 5 minutes during the procedure) until the patient is consciousness, followed by the first of five sets of MOAAS/S measurements upon completion of the procedure or when the last dose of medication is given.
Frequency of hypotension in both groups of patients and comparing the results between the SG and CG.
Hypotension during the procedure using sedation or propofol is defined as:
a decrease in systolic systemic pressure of 20% or more compared with the first measurement before the administration of remimazolam besylata or propofol.
A mean arterial pressure of ≤60 mmHg during while the patient is under sedation.
- Sinus bradycardia is defined as a decreased cardiac rate. 5. The frequency of respiratory depression compared between the two groups, SG and CG.
Respiratory depression during sedation is defined as:
Respiratory rate of <8 breaths per minute and/or a peripheral blood oxygen percentage of (SpO2) <90.
- BIS monitoring. 7. The success of procedural sedation using remimazolam besylate and sedation using propofol:
Will be shown as the percentage of successfully sedated patients defined as:
The completion of endoscopic polypectomy, without the need for rapid/fast acting emergency sedation or a maximum number of 5 additional doses given withing 15 minutes of the first dose to maintain adequate sedation.
- The time to achieve adequate sedation is defined as the time from administering the first dose of medication until achieving <3 points on the MOAA/S scale and/ora BIS.
- The time to achieve full consciousness is defined as the time since the administration of the last dose of medication until the patient is fully aware, or until the patients has 5 points on the MOAA/S scale.
- The time needed for the patient to fully recover after the procedure in both groups is defined by the criteria for patient dismissal using the - Modified Aldrete score scale.
The total volume of the given crystalloid solution (Plasma-lyte) will be measured in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Comparation of two drug grups in controlled medical environment.
| Arm | Type | Receives |
|---|---|---|
| Remimazolam besylat | Experimental | Drug: Remimazolam besylate |
| Propofol | Active comparator | Drug: Propofol |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (20 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remimazolam besylateThe 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 | Remimazolam besylat |
| PropofolThe 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. | Drug | Propofol |
Primary outcome
Hemodynamic Stability - Mean Arterial Pressure (MAP)
Time frame: from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.
Mean arterial pressure (mmHg) measured at multiple timepoints to assess overall circulatory stability. Comparison of MAP values between remimazolam and propofol groups.
Hemodynamic Stability - Systolic and Diastolic Blood Pressure
Time frame: from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.
Systolic and diastolic blood pressure (mmHg) measured at multiple timepoints to assess circulatory stability. Comparison between remimazolam and propofol groups.
Hemodynamic Stability - Heart Rate
Time frame: from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.
Heart rate (beats per minute) measured continuously via ECG monitoring. Comparison of heart rate values between study groups.
Incidence of Hypotension
Time frame: from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.
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
Incidence of Bradycardia
Time frame: from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.
Bradycardia is defined as a heart rate (HR) below 50 beats per minute (bpm), or a clinically significant decrease in HR of ≥20% from the pre-induction baseline, sustained for ≥1 minute and/or requiring pharmacological or non-pharmacological intervention (e.g., atropine administration, reduction or discontinuation of the study drug). HR will be continuously monitored via standard intraoperative ECG monitoring and recorded at predefined time points: baseline (pre-induction), immediately post-induction (T1), at 5-minute intervals intraoperatively, at emergence from anesthesia, and at 15 and 30 minutes postoperatively in the post-anesthesia care unit (PACU). The incidence of bradycardia will be expressed as the proportion of patients experiencing at least one episode meeting the above criteria within the defined observation window.
Respiratory Stability - Oxygen Saturation (SpO₂)
Time frame: from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.
Peripheral oxygen saturation (%) measured continuously via pulse oximetry. Comparison of SpO₂ values between study groups.
Incidence of Respiratory Depression
Time frame: from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.
Percentage of participants experiencing respiratory depression defined as: Respiratory rate <8 breaths per minute, AND/OR Peripheral oxygen saturation (SpO₂) <90%
11 secondary outcomes
Procedural Sedation Success Rate
Time frame: During the endoscopic procedure (estimated 30-50 minutes
Time to Adequate Sedation Level
Time frame: From first drug administration until adequate sedation achieved (estimated 1-5 minutes)
Time to Full Alertness
Time frame: From last drug administration until full alertness (estimated 10-20 minutes post-procedure)
Time to Recovery Room Discharge Readiness
Time frame: From last drug administration until meeting discharge criteria (estimated 15-30 minutes post-procedure)
Depth of Sedation - BIS Values
Time frame: From baseline through procedure completion until full alertness (estimated 30-60 minutes)
Depth of Sedation - MOAA/S Scores
Time frame: Baseline, immediately after drug administration, then every 30 seconds for 3 minutes, then as clinically indicated during procedure
Total Drug Dosage
Time frame: During procedure (estimated 30-50 minutes)
Procedure and sedation duration
Time frame: From first drug administration to full alertness (estimated 30-60 minutes) From procedure start to procedure completion (estimated 30-50 minutes)
Total Crystalloid Infusion Volume
Time frame: During procedure and recovery (estimated 30-90 minutes)
Incidence of Post-Procedure Pain, nausea and vomiting
Time frame: ost-procedure assessment before recovery room discharge (estimated 30-60 minutes after last drug dose)
Satisfaction Score
Time frame: Post-procedure before recovery room discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Background: PubMed 34381792Zhu X, Wang H, Yuan S, Li Y, Jia Y, Zhang Z, Yan F, Wang Z. Efficacy and Safety of Remimazolam in Endoscopic Sedation-A Systematic Review and Meta-Analysis. Front Med (Lausanne). 2021 Jul 26;8:655042. doi: 10.3389/fmed.2021.655042. eCollection 2021.
- Background: PubMed 36004376Qiu Y, Gu W, Zhao M, Zhang Y, Wu J. The hemodynamic stability of remimazolam compared with propofol in patients undergoing endoscopic submucosal dissection: A randomized trial. Front Med (Lausanne). 2022 Aug 8;9:938940. doi: 10.3389/fmed.2022.938940. eCollection 2022.
- Background: PubMed 35689208Guo J, Qian Y, Zhang X, Han S, Shi Q, Xu J. Remimazolam tosilate compared with propofol for gastrointestinal endoscopy in elderly patients: a prospective, randomized and controlled study. BMC Anesthesiol. 2022 Jun 10;22(1):180. doi: 10.1186/s12871-022-01713-6.
- Background: PubMed 35974309Xin Y, Chu T, Wang J, Xu A. Sedative effect of remimazolam combined with alfentanil in colonoscopic polypectomy: a prospective, randomized, controlled clinical trial. BMC Anesthesiol. 2022 Aug 16;22(1):262. doi: 10.1186/s12871-022-01805-3.
- Background: PubMed 32677707Chen SH, Yuan TM, Zhang J, Bai H, Tian M, Pan CX, Bao HG, Jin XJ, Ji FH, Zhong TD, Wang Q, Lv JR, Wang S, Li YJ, Yu YH, Luo AL, Li XK, Min S, Li L, Zou XH, Huang YG. Remimazolam tosilate in upper gastrointestinal endoscopy: A multicenter, randomized, non-inferiority, phase III trial. J Gastroenterol Hepatol. 2021 Feb;36(2):474-481. doi: 10.1111/jgh.15188. Epub 2020 Jul 24.
- Background: PubMed 33413147Dossa F, Megetto O, Yakubu M, Zhang DDQ, Baxter NN. Sedation practices for routine gastrointestinal endoscopy: a systematic review of recommendations. BMC Gastroenterol. 2021 Jan 7;21(1):22. doi: 10.1186/s12876-020-01561-z.
- Background: PubMed 30019172Sahinovic MM, Struys MMRF, Absalom AR. Clinical Pharmacokinetics and Pharmacodynamics of Propofol. Clin Pharmacokinet. 2018 Dec;57(12):1539-1558. doi: 10.1007/s40262-018-0672-3.
- Background: PubMed 25502841Borkett KM, Riff DS, Schwartz HI, Winkle PJ, Pambianco DJ, Lees JP, Wilhelm-Ogunbiyi K. A Phase IIa, randomized, double-blind study of remimazolam (CNS 7056) versus midazolam for sedation in upper gastrointestinal endoscopy. Anesth Analg. 2015 Apr;120(4):771-80. doi: 10.1213/ANE.0000000000000548.
- Background: PubMed 29723512Rex DK, Bhandari R, Desta T, DeMicco MP, Schaeffer C, Etzkorn K, Barish CF, Pruitt R, Cash BD, Quirk D, Tiongco F, Sullivan S, Bernstein D. A phase III study evaluating the efficacy and safety of remimazolam (CNS 7056) compared with placebo and midazolam in patients undergoing colonoscopy. Gastrointest Endosc. 2018 Sep;88(3):427-437.e6. doi: 10.1016/j.gie.2018.04.2351. Epub 2018 Apr 30.
- Background: PubMed 35139608Kim KM. Remimazolam: pharmacological characteristics and clinical applications in anesthesiology. Anesth Pain Med (Seoul). 2022 Jan;17(1):1-11. doi: 10.17085/apm.21115. Epub 2022 Jan 20.
- Background: PubMed 28877145Hinkelbein J, Lamperti M, Akeson J, Santos J, Costa J, De Robertis E, Longrois D, Novak-Jankovic V, Petrini F, Struys MMRF, Veyckemans F, Fuchs-Buder T, Fitzgerald R. European Society of Anaesthesiology and European Board of Anaesthesiology guidelines for procedural sedation and analgesia in adults. Eur J Anaesthesiol. 2018 Jan;35(1):6-24. doi: 10.1097/EJA.0000000000000683.
- Individual participant dataSharing planned: Undecided. Individual participant data will not be shared due to regulatory, ethical, and practical constraints. Croatian healthcare data protection law (NN 14/19) and GDPR regulations mandate strict safeguarding of personal health information. The informed consent obtained from participants explicitly limits data use to this specific study and does not authorize sharing of individual-level data with external parties. Given the relatively small sample size (n=100) and the specific clinical context at a single tertiary center, there is meaningful risk of participant re-identification even with standard de-identification procedures. Additionally, our institution lacks the technical infrastructure for secure data repository management and controlled access mechanisms necessary for responsible IPD sharing. Resources for comprehensive data curation, security auditing, and long-term stewardship were not included in the study budget. However, we are committed to research transparency.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam besylate and Propofol in people with Colonic Polyp and Sedation Complication, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Željko Drvar, MD, PhD (003851 2388 888, zeljko.drvar@kbc-zagreb.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic Stability - Mean Arterial Pressure (MAP) (time frame: from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07456111, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.