Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-24 @ 3:32 PM
NCT ID:
NCT05412992
Eligibility Criteria:
Inclusion Criteria:
* Male or female, ≥ 18 years of age.
* Scheduled to undergo a full abdominoplasty (including repair of small incidental abdominal hernias, but not including liposuction).
* Have a physical status classification of 1 or 2 per the American Society of Anesthesiology.
* Have a body weight \> 58 kg, and body mass index of 20 to 38 kg/m2, inclusive.
Exclusion Criteria:
* Known sensitivity to dexmedetomidine or any excipient in the DMTS/placebo or to any peri- or postoperative medication whose use is required in this study.
* Skin abnormality (eg, scar, tattoo) or unhealthy skin condition (eg, burns, wounds) at the DMTS/matching placebo application site, according to examination by the investigator at screening or admission to the clinic prior to surgery.
* History of deep vein thrombosis or factor V Leiden deficiency.
* History of syncope or other syncopal attacks.
* Present and/or significant history of postural hypotension (determined through examination by the investigator or designee), or history of severe dizziness or fainting on standing in the opinion of the investigator.
* Evidence of a clinically significant 12-lead ECG abnormality.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05412992
Study Brief:
Protocol Section:
NCT05412992