NCT07213544

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for phase_4

Timeline
8mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress43%
Nov 2025Jan 2027

First Submitted

Initial submission to the registry

September 22, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 9, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

November 12, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

1.1 years

First QC Date

September 22, 2025

Last Update Submit

November 17, 2025

Conditions

Burn ScarHypertrophic ScarringProcedural Sedation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Time from initiation of sedation to peak sedation

    up to 24 hours after procedure ends

  • Time of cessation of sedation to full recovery

    up to 24 hours after procedure ends

  • Cessation of sedation to full recovery

    up to 24 hours after the procedure ends

  • Satisfaction with Anesthesia

    up to 24 hours after the procedure ends

  • Felling pain on injection of sedation medication

    up to 24 hours after the procedure ends

Other Outcomes (3)

  • Incidence of hypotension

    up to 24 hours after the procedure ends

  • Incidence of low EtCO2

    up to 24 hours after the procedure ends

  • Incidence of hypoxemia

    up to 24 hours after the procedure ends

Study Arms (2)

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.

Drug: Remimazolam besylateDrug: Propofol

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.

Drug: Remimazolam besylateDrug: Propofol

Interventions

Remimazolam besylateDRUG

Remimazolam

Propofol followed by RemimazolamRemimazolam followed by Propofol
PropofolDRUG

Propofol

Propofol followed by RemimazolamRemimazolam followed by Propofol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Interventions

Propofol

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Rishi Patel, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haley Nitchie

CONTACT

(843) 792-1869nitchie@musc.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor-Faculty

Study Record Dates

First Submitted

September 22, 2025

First Posted

October 9, 2025

Study Start

November 12, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)