Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
NCT Number: NCT03933306
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.
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Notify Me50 year and older
All sexes
Interventional
Phase 4
Beijing, Beijing Municipality, 100034, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Dexmedetomidine hydrochloride injection
Loading dose placebo administered before anesthesia induction, followed by a continuous infusion until 1 hour before the end of surgery.
Other names: Normal saline
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.
Time frame: Up to 30 days after surgery.
A composite endpoint including delirium, acute kidney injury, myocardial injury, and other complications after surgery.
Time frame: Up to 7 days after surgery.
A composite endpoint including delirium, acute kidney injury, myocardial injury, and other complications after surgery.
Time frame: Up to 30 days after surgery.
Length of stay in the intensive care unit after surgery.
Time frame: Up to 30 days after surgery.
Length of stay in hospital after surgery.
Time frame: Up to 30 days after surgery.
Rate of death due to any cause within 30 days after surgery.
Time frame: Up to 3 years after surgery.
Overall survival after surgery.
Time frame: Up to 3 years after surgery.
Disease-free survival after surgery.
Time frame: At the end of 3 years after surgery.
Quality of life is assessed with with the World Health Organization quality of life scale brief version (WHOQOL-BREF).
Time frame: At the end of 3 years after surgery.
Cognitive function is assessed with the Telephone Interview for Cognitive Status-Modified (TICS-m).
Peking University First Hospital
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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