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

NCT07456111 | Recruiting Phase 4

• 1 other identifier: LOC-100018379
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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 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

Keywords

Remimazolam besylate; Propofol; Procedural sedation; Polypectomy; Circulatory stability; Respiratory stability; Respiratory depression

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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

  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.

  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.

  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%

  from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.

Secondary Outcomes (11)

• Procedural Sedation Success Rate

  During the endoscopic procedure (estimated 30-50 minutes

• Time to Adequate Sedation Level

  From first drug administration until adequate sedation achieved (estimated 1-5 minutes)

• Time to Full Alertness

  From last drug administration until full alertness (estimated 10-20 minutes post-procedure)

• Time to Recovery Room Discharge Readiness

  From last drug administration until meeting discharge criteria (estimated 15-30 minutes post-procedure)

• Depth of Sedation - BIS Values

  From baseline through procedure completion until full alertness (estimated 30-60 minutes)

Study Arms (2)

Remimazolam besylat

EXPERIMENTAL

Drug: Remimazolam besylate

Propofol

ACTIVE COMPARATOR

Drug: Propofol

Interventions

Remimazolam besylate DRUG

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.

Remimazolam besylat

Propofol DRUG

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.

Propofol

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify 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.
• 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.

You may not qualify 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),
• 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.

Sponsors & Collaborators

• Clinical Hospital Centre Zagreb: lead

Study Sites (1)

UHC Zagreb

Zagreb, 10000, Croatia

RECRUITING

Related Publications (11)

• 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.

  PMID: 34381792 BACKGROUND

• Qiu 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.

  PMID: 36004376 BACKGROUND

• Guo 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.

  PMID: 35689208 BACKGROUND

• Xin 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.

  PMID: 35974309 BACKGROUND

• Chen 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.

  PMID: 32677707 BACKGROUND

• Dossa 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.

  PMID: 33413147 BACKGROUND

• Sahinovic 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.

  PMID: 30019172 BACKGROUND

• Borkett 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.

  PMID: 25502841 BACKGROUND

• Rex 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.

  PMID: 29723512 BACKGROUND

• Kim 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.

  PMID: 35139608 BACKGROUND

• Hinkelbein 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.

  PMID: 28877145 BACKGROUND

MeSH Terms

Conditions

Colonic Polyps; Respiratory Insufficiency

Interventions

Propofol

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Željko Drvar, MD, PhD

CONTACT

003851 2388 888; zeljko.drvar@kbc-zagreb.hr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Considering that this is a single blind study, neither the controlled group nor the study group will be aware of which medication they are given because the method of administration is the same (therapeutic gold standard). The only individual who will know which medication is administered will be the primary researcher/anesthesiologist who will be administering the medication themselves.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal invesitgator

Model Details: Comparation of two drug grups in controlled medical environment.

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: March 6, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

CR (1)