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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam followed by Propofol | Active Comparator | Patients will be randomized to receive Remimazolam 0.075 mg/kg (maximum of 5 mg) for sedation during their first laser therapy session, then 4-6 weeks later at their next laser therapy session they will receive propofol 0.8 mg/kg IV bolus for sedation. |
|
| Propofol followed by Remimazolam | Active Comparator | Patients will be randomized to receive Propofol 0.8 mg/kg IV bolus for sedation during their first laser therapy session, then 4-6 weeks later at their next laser therapy session they will receive Remimazolam 0.075 mg/kg (maximum of 5 mg) for sedation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam besylate | Drug | Remimazolam |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of respiratory depression | 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. | up to 24 hours after procedure ends |
| Measure | Description | Time Frame |
|---|---|---|
| Time from initiation of sedation to peak sedation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hypotension | 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. | up to 24 hours after the procedure ends |
| Incidence of low EtCO2 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haley Nitchie | Contact | (843) 792-1869 | nitchie@musc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rishi Patel, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
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| ID | Term |
|---|---|
| D017439 | Cicatrix, Hypertrophic |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Propofol | Drug | Propofol |
|
| up to 24 hours after procedure ends |
| Time of cessation of sedation to full recovery | 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. | up to 24 hours after procedure ends |
| Cessation of sedation to full recovery | 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). | up to 24 hours after the procedure ends |
| Satisfaction with Anesthesia | 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. | up to 24 hours after the procedure ends |
| Felling pain on injection of sedation medication | 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. | 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. |
| up to 24 hours after the procedure ends |
| Incidence of hypoxemia | Baseline SpO2 and lowest SpO2 will be recorded to evaluate incidence of hypoxemia during the procedure. | up to 24 hours after the procedure ends |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |