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OpenTrials
Active, Not Recruiting

NCT Number: NCT07362173

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

ASA Class III/IV Patients Age 65 and Older COPD III/IV Multiple Organ Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Regional Institute of Gastroenterology-Hepatology Prof. Dr. Octavian Fodor

Cluj-Napoca, Cluj, Romania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Age below 65 years
  • Pediatric population
  • Refusal or inability to provide informed consent
  • Severe allergy to study drugs
  • Pregnancy or breastfeeding

Treatment and study plan

Administering remimazolam

Drug

Administering Remimazolam for procedural sedation

Administering propofol

Drug

Administering Propofol for procedural sedation

Primary outcomes

  1. Heart rate (beats per minute)

    Time frame: Periprocedural

    The lowest heart rate will be recorded

  2. Mean arterial pressure (mmHg)

    Time frame: Periprocedural

    The lowest mean arterial pressure will be recorded

  3. Incidence of hypotension requiring vasoactive support (Yes/No)

    Time frame: Periprocedural

    The presence of hypotension requiring vasoactive drug administration will be recorded.

Secondary outcomes

  1. Patient satisfaction

    Time frame: Postprocedural

    Patient satisfaction will be recorded as a single score per participant.

  2. Endoscopist satisfaction (5-point Likert scale)

    Time frame: Periprocedural

    Endoscopist satisfaction will be evaluated and recorded as a single 5-point Likert score per participant.

  3. Quality of recovery (ordinal scale)

    Time frame: Periprocedural

    Quality of recovery will be assessed using an ordinal clinical scale and reported as a single score per participant.

  4. Incidence of postoperative nausea and vomiting (Yes/No)

    Time frame: Periprocedural

    The presence of nausea and/or vomiting will be recorded.

  5. Total dose of sedative administered (mg)

    Time frame: Periprocedural

    Total intravenous dose of the sedative agent administered during the procedure.

  6. Need for airway intervention due to apnea (Yes/No)

    Time frame: Periprocedural

    The need for airway support due to apnea will be recorded.

  7. Incidence of apnea (Yes/No)

    Time frame: Periprocedural

    The occurrence of apnea during procedural sedation will be recorded.

  8. Peripheral oxygen saturation (SpO₂,%)

    Time frame: Periprocedural

    Peripheral capillary oxygen saturation will be measured using pulse oximetry and summarized as the mean periprocedural value.

  9. Respiratory rate (breaths per minute)

    Time frame: Periprocedural

    Respiratory rate will be monitored during the periprocedural period.

  10. Duration of apnea (seconds)

    Time frame: Periprocedural

    Duration of apnea episodes will be measured in seconds.

  11. Need for change in sedation regimen (Yes/No)

    Time frame: Periprocedural

    The need to change the planned sedation regimen will be recorded.

  12. Incidence of postprocedural delirium (Yes/No)

    Time frame: Periprocedural

    Postprocedural delirium or agitation will be recorded.

  13. Incidence of adverse events (Yes/No)

    Time frame: Periprocedural

    The occurrence of adverse events related to procedural sedation will be recorded.

Sponsors and collaborators

Lead sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Other

Collaborators

  • Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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