NCT03933306

Intraoperative Goal-directed Blood Pressure and Dexmedetomidine on Outcomes

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 496 (actual)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The number of patients undergoing surgeries is increasing worldwide. However, some patients develop complications or even die after surgery. Perioperative organ injury is the leading cause of the unfavorable outcomes. Hypotension is not uncommon during major surgery and is highly responsible for the inadequate perfusion and organ injury. A recent study showed that individualized blood pressure management decreases the incidence of postoperative organ injury when compared with standard blood pressure management strategy. Dexmedetomidine is a highly selective alpha2 adrenergic agonist. Previous studies showed that dexmedetomidine provides organ protection in various conditions. In a recent meta-analysis, perioperative dexmedetomidine reduceds the occurrence of postoperative delirium. However, whether it can reduce postoperative complications remains inconclusive. This study aims to investigate the impact of intraoperative goal-directed blood pressure management and dexmedetomidine infusion on the incidence of postoperative organ injury in high-risk patients undergoing major abdominal surgery.

Conditions

• Blood Pressure
• Dexmedetomidine
• High-risk Patients
• Abdominal Surgery
• Postoperative Complications

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	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.
DRUG	Placebo	Loading dose placebo administered before anesthesia induction, followed by a continuous infusion until 1 hour before the end of surgery.
OTHER	Goal-directed blood pressure management	Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
OTHER	Routine blood pressure 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.

Timeline

• Start date: 2019-05-20
• Primary completion: 2020-10-29
• Completion: 2024-05-30
• First posted: 2019-05-01
• Last updated: 2025-07-18

Locations

1 site across 1 country: China