At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Impact of Intraoperative Goal-directed Blood Pressure Management and Dexmedetomidine on Outcomes of High-risk Patients After Major Abdominal Surgeries: a 2×2 Factorial Randomized Controlled Trial
In Brief
A Phase 4 clinical trial evaluating Dexmedetomidine, Placebo, and 2 other interventions for Blood Pressure and 4 related conditions. Completed, enrolled 496 participants across 1 site.
Detailed Summary
Perioperative organ injuriy remain an important threat to patients undergoing major surgeries. Intraoperative hypotension is associated with an increase in postoperative morbidity and mortality. Whereas individualized intraoperative blood pressure management is likely to decrease the incidence of postoperative organ injury when compared with standard blood pressure management strategy. Dexmedetomidine, a highly selective alpha2 adrenergic agonist, has been shown to provide organ protective effects. This study aims to investigate the impact of intraoperative goal-directed blood pressure management and dexmedetomidine infusion on incidence of postoperative organ injury in high-risk patients undergoing major surgery.
Study Details
Timeline
Interventions
Loading dose dexmedetomidine (0.6 mcg/kg for 10 min) administered before anesthesia induction, followed by a continuous infusion (0.5 mcg/kg/h) until 1 hour before the end of surgery.
Loading dose placebo administered before anesthesia induction, followed by a continuous infusion until 1 hour before the end of surgery.
Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
Blood pressure is maintained according to routine practice, i.e., systolic blood pressure \> 90 mmHg or within ±30% of baseline within intermittent ephedrine or phenylephrine.