Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdom… (NCT05412992) | Clinical Trial Compass
TerminatedPhase 2
Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty
Stopped: The SMC recommended stopping the trial. hemodynamic effects.
United States179 participantsStarted 2022-07-07
Plain-language summary
The primary objective of this study is to evaluate the analgesic efficacy of DMTS, compared with placebo, in subjects following abdominoplasty.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Time-interval weighted summed pain intensity (SPI) at designated time points