Intraoperative Goal-directed Blood Pressure and Dexmedetomidine on Outcomes
NCT ID: NCT03933306
Last Updated: 2025-07-18
Study Results
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Basic Information
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COMPLETED
PHASE4
496 participants
INTERVENTIONAL
2019-05-20
2024-05-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
TRIPLE
Study Groups
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Placebo+routine blood pressure management
Placebo (normal saline) is administered during anesthesia. Blood pressure is managed according to routine practice.
Placebo
Loading dose placebo administered before anesthesia induction, followed by a continuous infusion until 1 hour before the end of surgery.
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.
Dexmedetomidine+routine blood pressure management
Dexmedetomidine is administered during anesthesia (0.6 mcg/kg for 10 min, then 0.5 mcg/kg/h). Blood pressure is managed according to routine practice.
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.
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.
Placebo+goal-directed blood pressure management
Placebo (normal saline) is administered during anesthesia. Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
Placebo
Loading dose placebo administered before anesthesia induction, followed by a continuous infusion until 1 hour before the end of surgery.
Goal-directed blood pressure management
Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
Dexmedetomidine+goal-directed blood pressure management
Dexmedetomidine is administered during anesthesia (0.6 mcg/kg for 10 min, then 0.5 mcg/kg/h). Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
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.
Goal-directed blood pressure management
Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
Interventions
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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.
Placebo
Loading dose placebo administered before anesthesia induction, followed by a continuous infusion until 1 hour before the end of surgery.
Goal-directed blood pressure management
Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled to undergo abdominal surgery under general anesthesia with an expected duration of 2 hours or longer;
* With a preoperative acute kidney injury risk index of class III or higher (meet 4 or more of the following factors: age ≥56 years, male sex, active congestive heart failure, ascites, hypertension, emergency surgery, intraperitoneal surgery, mild or moderate renal insuffificiency, diabetes mellitus requiring oral or insulin therapy).
Exclusion Criteria
* Acute or decompensated heart failure, acute coronary syndrome, or stroke within 1 month;
* Severe bradycardia (heart rate \< 50 bpm), sick sinus syndrome, second-degree or higher atrioventricular block without pacemaker, atrial fibrillation, or frequent premature beats;
* Severe hepatic dysfunction (Child-Pugh C) or chronic kidney disease (glomerular filtration rate \<30 ml/min/1.73 m2 or dependent on renal replacement therapy) ;
* Pregnant;
* Receiving dexmedetomidine or norepinephrine infusion before surgery;
* Do not provide written informed consent.
50 Years
ALL
No
Sponsors
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Peking University First Hospital
OTHER
Responsible Party
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Dong-Xin Wang
Professor and Chairman, Department of Anaesthesiology and Critical Care Medicine
Principal Investigators
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Dong-Xin Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Countries
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References
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Other Identifiers
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2019-73
Identifier Type: -
Identifier Source: org_study_id
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