ASA Class III/IV PatientsNCT07362173
Remimazolam Versus Propofol for Procedural Sedation in Gastrointestinal Endoscopy: A Single-Centre Prospective Observational Comparative Study in a High-Risk Population
An observational study of ASA Class III/IV Patients and COPD III/IV, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
Remimazolam is a new, ultra-short-acting benzodiazepine approved in Romania for procedural sedation. It shows significant clinical benefits compared to other sedatives like Propofol or Midazolam, especially in elderly or high-risk patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- ASA Class III/IV Patients, COPD III/IV, Age 65 and Older
- What is being tested?
- Administering remimazolam and Administering propofol
- Type of treatment
- Injection or infusion
- How many people
- 203 participants
- Where
- 1 siteRomania
- Study dates
- 1 Mar 2025to 1 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly high-risk patients undergoing elective gastrointestinal endoscopic procedures, predominantly ERCP, at a tertiary gastroenterology and hepatology institute in Cluj-Napoca, Romania. Eligible patients were aged ≥65 years, ASA physical status III-IV, and required anaesthesiologist-administered procedural sedation. Emergency procedures, pregnancy, known hypersensitivity to study medications, inability or refusal to provide informed consent, and ASA status other than III-IV were exclusion criteria.
Who may be able to join
- Adults aged 65 years or older
- ASA Physical Status classification III or IV
- Patients scheduled to undergo endoscopic procedures requiring procedural sedation
- Ability to provide written informed consent
Who cannot join
- Age below 65 years
- Pediatric population
- Refusal or inability to provide informed consent
- Severe allergy to study drugs
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
Romania1 site
Regional Institute of Gastroenterology-Hepatology Prof. Dr. Octavian Fodor
Cluj-Napoca, Cluj
About this study
Official title: Actualities in Procedural Sedation: Remimazolam
Remimazolam is a new, ultra-short-acting benzodiazepine approved in Romania for procedural sedation. It shows significant clinical benefits compared to other sedatives like Propofol or Midazolam, especially in elderly or high-risk patients. Advantages include better hemodynamic stability, reduced respiratory depression, lower incidence of postoperative delirium, and rapid recovery without residual sedation. It is metabolized by liver esterases and is less affected by organ dysfunction. Clinical studies suggest that remimazolam may be a safer and more effective alternative in procedural and general anesthesia. The findings support the development of institutional protocols for its use, particularly in high-risk populations and endoscopic procedures.
- Being tested
- Administering remimazolam, Administering propofol
- Medical subject headings
- Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administering remimazolamDrug
Administering Remimazolam for procedural sedation
Administering propofolDrug
Administering Propofol for procedural sedation
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam | Lot 1 - Participants in this arm will receive remimazolam for procedural sedation. Remimazolam will be administered intravenously according to the institutional sedation protocol, with dosing adjusted to achieve adequate procedural sedation. Receives: Drug: Administering remimazolam | |
| Propofol | Lot 2 - Participants in this arm will receive Propofol for procedural sedation. Propofol will be administered intravenously according to standard clinical practice, with dosing adjusted to achieve adequate procedural sedation. Receives: Drug: Administering propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate (beats per minute)
The lowest heart rate will be recorded
Measured: Periprocedural
Mean arterial pressure (mmHg)
The lowest mean arterial pressure will be recorded
Measured: Periprocedural
Incidence of hypotension requiring vasoactive support (Yes/No)
The presence of hypotension requiring vasoactive drug administration will be recorded.
Measured: Periprocedural
Secondary outcomes (13)
Patient satisfaction
Patient satisfaction will be recorded as a single score per participant.
Measured: Postprocedural
Endoscopist satisfaction (5-point Likert scale)
Endoscopist satisfaction will be evaluated and recorded as a single 5-point Likert score per participant.
Measured: Periprocedural
Quality of recovery (ordinal scale)
Quality of recovery will be assessed using an ordinal clinical scale and reported as a single score per participant.
Measured: Periprocedural
Incidence of postoperative nausea and vomiting (Yes/No)
The presence of nausea and/or vomiting will be recorded.
Measured: Periprocedural
Total dose of sedative administered (mg)
Total intravenous dose of the sedative agent administered during the procedure.
Measured: Periprocedural
Need for airway intervention due to apnea (Yes/No)
The need for airway support due to apnea will be recorded.
Measured: Periprocedural
Incidence of apnea (Yes/No)
The occurrence of apnea during procedural sedation will be recorded.
Measured: Periprocedural
Peripheral oxygen saturation (SpO₂,%)
Peripheral capillary oxygen saturation will be measured using pulse oximetry and summarized as the mean periprocedural value.
Measured: Periprocedural
Respiratory rate (breaths per minute)
Respiratory rate will be monitored during the periprocedural period.
Measured: Periprocedural
Duration of apnea (seconds)
Duration of apnea episodes will be measured in seconds.
Measured: Periprocedural
Need for change in sedation regimen (Yes/No)
The need to change the planned sedation regimen will be recorded.
Measured: Periprocedural
Incidence of postprocedural delirium (Yes/No)
Postprocedural delirium or agitation will be recorded.
Measured: Periprocedural
Incidence of adverse events (Yes/No)
The occurrence of adverse events related to procedural sedation will be recorded.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Mar 2025
- Primary completion1 May 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASA Class III/IV PatientsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362173
- Sponsor's protocol ID
- 5129/29.04.2025, AVZ213/21.07
- Status last verified
- Oct 2026
- First submitted
- 4 Jul 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the investigator-initiated nature of the study and local data protection regulations, individual participant data will not be made available for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Actualities in Procedural Sedation: Remimazolam
- ClinicalTrials.gov ID
- NCT07362173
- Acronym / sponsor ID
- 5129/29.04.2025, AVZ213/21.07
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Collaborators
- Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 23 Jan 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.
Remimazolam is a new, ultra-short-acting benzodiazepine approved in Romania for procedural sedation. It shows significant clinical benefits compared to other sedatives like Propofol or Midazolam, especially in elderly or high-risk patients. Advantages include better hemodynamic stability, reduced respiratory depression, lower incidence of postoperative delirium, and rapid recovery without residual sedation. It is metabolized by liver esterases and is less affected by organ dysfunction. Clinical studies suggest that remimazolam may be a safer and more effective alternative in procedural and general anesthesia. The findings support the development of institutional protocols for its use, particularly in high-risk populations and endoscopic procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam | – | Drug: Administering remimazolamLot 1 - Participants in this arm will receive remimazolam for procedural sedation. Remimazolam will be administered intravenously according to the institutional sedation protocol, with dosing adjusted to achieve adequate procedural sedation. |
| Propofol | – | Drug: Administering propofolLot 2 - Participants in this arm will receive Propofol for procedural sedation. Propofol will be administered intravenously according to standard clinical practice, with dosing adjusted to achieve adequate procedural sedation. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly high-risk patients undergoing elective gastrointestinal endoscopic procedures, predominantly ERCP, at a tertiary gastroenterology and hepatology institute in Cluj-Napoca, Romania. Eligible patients were aged ≥65 years, ASA physical status III-IV, and required anaesthesiologist-administered procedural sedation. Emergency procedures, pregnancy, known hypersensitivity to study medications, inability or refusal to provide informed consent, and ASA status other than III-IV were exclusion criteria.
Key inclusion criteria (4 listed)
- Adults aged 65 years or older
- ASA Physical Status classification III or IV
- Patients scheduled to undergo endoscopic procedures requiring procedural sedation
- Ability to provide written informed consent
Key exclusion criteria (5 listed)
- Age below 65 years
- Pediatric population
- Refusal or inability to provide informed consent
- Severe allergy to study drugs
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Administering remimazolamAdministering Remimazolam for procedural sedation | Drug | Remimazolam |
| Administering propofolAdministering Propofol for procedural sedation | Drug | Propofol |
Primary outcome
Heart rate (beats per minute)
Time frame: Periprocedural
The lowest heart rate will be recorded
Mean arterial pressure (mmHg)
Time frame: Periprocedural
The lowest mean arterial pressure will be recorded
Incidence of hypotension requiring vasoactive support (Yes/No)
Time frame: Periprocedural
The presence of hypotension requiring vasoactive drug administration will be recorded.
13 secondary outcomes
Patient satisfaction
Time frame: Postprocedural
Endoscopist satisfaction (5-point Likert scale)
Time frame: Periprocedural
Quality of recovery (ordinal scale)
Time frame: Periprocedural
Incidence of postoperative nausea and vomiting (Yes/No)
Time frame: Periprocedural
Total dose of sedative administered (mg)
Time frame: Periprocedural
Need for airway intervention due to apnea (Yes/No)
Time frame: Periprocedural
Incidence of apnea (Yes/No)
Time frame: Periprocedural
Peripheral oxygen saturation (SpO₂,%)
Time frame: Periprocedural
Respiratory rate (breaths per minute)
Time frame: Periprocedural
Duration of apnea (seconds)
Time frame: Periprocedural
Need for change in sedation regimen (Yes/No)
Time frame: Periprocedural
Incidence of postprocedural delirium (Yes/No)
Time frame: Periprocedural
Incidence of adverse events (Yes/No)
Time frame: Periprocedural
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No. Due to the investigator-initiated nature of the study and local data protection regulations, individual participant data will not be made available for sharing.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ASA Class III/IV Patients and COPD III/IV, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 15 Oct 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 Romania. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (beats per minute) (time frame: Periprocedural). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.