Burn Scar, Hypertrophic Scarring, Procedural Sedation
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DRUGRemimazolam besylate
Remimazolam
DRUGPropofol
Propofol
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of respiratory depression | 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
| Measure | Time frame | Description |
|---|---|---|
| Time of cessation of sedation to full recovery | 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. |
| Cessation of sedation to full recovery | 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). |
| Satisfaction with Anesthesia | 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. |
| Felling pain on injection of sedation medication | 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. |
| Time from initiation of sedation to peak sedation | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hypoxemia | up to 24 hours after the procedure ends | Baseline SpO2 and lowest SpO2 will be recorded to evaluate incidence of hypoxemia during the procedure. |
| Incidence of low EtCO2 | 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. |
| Incidence of hypotension | 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. |
Countries
United States
Contacts
Primary ContactHaley Nitchie
Outcome results
None listed