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NCT Number: NCT07213544

Remimazolam vs Propofol in Laser Burn Cases

This randomized, single-blind, crossover study compares remimazolam and propofol for monitored anesthetic care during fractional ablative CO₂ laser therapy for burn scars. The primary aim is to assess incidence of respiratory depression, defined as a need for advanced airway maneuvers (jaw thrust/chin lift, insertion of oral or nasal airway, or bag mask ventilation), and hypopnea (respiratory rate < 8).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location status: Recruiting

Location contact

Rishi Patel, M.D.

PRINCIPAL_INVESTIGATOR

About this study

Patients will be randomized to receive either remimazolam or propofol during their first laser session, and the alternate drug during their second session 4-6 weeks later. Outcomes include respiratory depression, sedation onset and recovery times, hemodynamic changes, and patient satisfaction.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • Undergoing both outpatient Session #1 and Session #2 of fractional ablative CO2 laser therapy

Exclusion criteria

  • History of previous fractional ablative laser therapy for burn scar
  • Procedure expected to last longer than 30 minutes
  • Allergy such as dextran 40 or contraindication to either of the study drugs
  • Pregnant and/or breastfeeding
  • Subjects who are unable to or choose not to give informed consent

Treatment and study plan

Remimazolam besylate

Drug

Remimazolam

Propofol

Drug

Propofol

Primary outcomes

  1. Incidence of respiratory depression

    Time frame: up to 24 hours after procedure ends

    The incidence of respiratory depression will include need for advanced airway maneuvers, or hypopnea events. Advanced airway maneuvers during the laser therapy procedure may include jaw thrust, chin lift, insertion of oral or nasal airway, or bag mask ventilation. A hypopnea event is defined as a respiratory rate <8.

Secondary outcomes

  1. Time from initiation of sedation to peak sedation

    Time frame: up to 24 hours after procedure ends

    Time from initiation of sedation to peak sedation will be measured in minutes and calculated from the start time of induction to peak sedation when patient reaches a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score of less than 3. The MOAA/S scale ranges from 0 to 5, with higher scores indicating greater alertness and lower scores indicating deeper sedation:

    5: Responds readily to name spoken in a normal tone. 4: Lethargic response to name spoken in a normal tone. 3: Responds only after name is called loudly or repeatedly. 2: Responds only after mild prodding or shaking.

    1: Responds only after a painful trapezius squeeze. 0: Does not respond to a painful trapezius squeeze.

  2. Time of cessation of sedation to full recovery

    Time frame: up to 24 hours after procedure ends

    Time of cessation of sedation to full recovery will be evaluated in minutes by marking when the last dose of anesthetic medication is given (cessation of sedation), to when the patient has reached full recovery from anesthesia. Full recovery from anesthesia is defined as when the patient reaches a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≥ 4.

    The MOAA/S scale ranges from 0 to 5, with higher scores indicating greater alertness and lower scores indicating deeper sedation:

    5: Responds readily to name spoken in a normal tone. 4: Lethargic response to name spoken in a normal tone. 3: Responds only after name is called loudly or repeatedly. 2: Responds only after mild prodding or shaking.

    1: Responds only after a painful trapezius squeeze. 0: Does not respond to a painful trapezius squeeze.

  3. Cessation of sedation to full recovery

    Time frame: up to 24 hours after the procedure ends

    Cessation of sedation to full recovery will also be evaluated as length of PACU stay. This will be measured from the time the patient left the procedure room, to the time they are ready for discharge (marked as procedural care complete).

  4. Satisfaction with Anesthesia

    Time frame: up to 24 hours after the procedure ends

    Satisfaction with Anesthesia will be measured using the Iowa Satisfaction with Anesthesia Scale (ISAS) approximately 15 minutes to two hours after arrival to to the recovery unit. This measures their satisfaction with Monitored Anesthesia Care (MAC).

    ISAS is an 11-item questionnaire designed to measure the satisfaction with monitored anesthesia care. The ISAS score is the mean of responses to all 11 questions. The score ranges from a minimum of -3 to a maximum of +3 when averaged together. The responses are: -3 = disagree very much, -2 = disagree moderately, -1 = disagree slightly, 1 = agree slightly, 2 = agree moderately, and 3 = agree very much. A score of +3 would imply a completely satisfied patient.

  5. Felling pain on injection of sedation medication

    Time frame: up to 24 hours after the procedure ends

    Subjects will be asked if they felt pain upon the injection of the sedation medications, and will answer "yes" or "no". This will be asked at least 15 minutes after arriving to the recovery area after the procedure. "No" indicates they did not feel pain upon injection which means a better outcome.

Other outcomes

  1. Incidence of hypotension

    Time frame: up to 24 hours after the procedure ends

    Incidence of hypotension during the procedure will measured by the use of vasopressors such as Norepinephrine or equivalent, as well as the lowest blood pressure reading during the procedure.

  2. Incidence of low EtCO2

    Time frame: up to 24 hours after the procedure ends

    Incidence of low EtCO2 will be measured by recording the lowest intraoperative EtCO2 reading during the procedure.

  3. Incidence of hypoxemia

    Time frame: up to 24 hours after the procedure ends

    Baseline SpO2 and lowest SpO2 will be recorded to evaluate incidence of hypoxemia during the procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Haley Nitchie

CONTACT

[email protected]

(843) 792-1869

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Comparison of Remimazolam Versus Propofol for Monitored Anesthetic Care in Elective Fractional Ablative CO₂ Laser

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 9, 2025
Registry last updated
Nov 20, 2025

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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