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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Intraoperative Goal-directed Blood Pressure and Dexmedetomidine

Clinicaltrials.gov identifier NCT03933306

Recruitment Status Active, not recruiting

First Posted May 1, 2019

Last update posted February 4, 2021

Study Description

Brief 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.

  • Condition or Disease:Postoperative Complications
    Blood Pressure
    Abdominal Surgery
    High-risk Patients
    Dexmedetomidine
  • Intervention/Treatment: Drug: Dexmedetomidine
    Drug: Placebo
    Other: Goal-directed blood pressure management
    Other: Routine blood pressure management
  • Phase: Phase 4
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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 496 participants
  • Allocation: Randomized
  • Intervention Model: Factorial Assignment
  • Intervention Model Description: This is a 2x2 factorial trial
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Primary Purpose: Prevention
  • Official Title: 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
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: October 2020
  • Actual Study Completion Date: May 2023
Arms and interventions
Arm Intervention/treatment
Experimental: 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.
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.

Other: Goal-directed blood pressure management
Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
Experimental: 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.
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.

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.
Experimental: 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.
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.
Placebo Comparator: Placebo+routine blood pressure management
Placebo (normal saline) is administered during anesthesia. Blood pressure is managed according to routine practice.
Drug: Placebo
Loading dose placebo administered before anesthesia induction, followed by a continuous infusion until 1 hour before the end of surgery.

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.
Outcome Measures
  • Primary Outcome Measures: 1. Incidence of organ injury and other complications within 30 days after surgery. [ Time Frame: Up to 30 days after surgery. ]
    A composite endpoint including delirium, acute kidney injury, myocardial injury, and other complications after surgery.
  • Secondary Outcome Measures: 1. Incidence of organ injury and other complications within 7 days 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.
  • 2. Length of stay in the intensive care unit after surgery. [ Time Frame: Up to 30 days after surgery. ]
    Length of stay in the intensive care unit after surgery.
  • 3. Length of stay in hospital after surgery. [ Time Frame: Up to 30 days after surgery. ]
    Length of stay in hospital after surgery.
  • 4. 30-day all-cause mortality. [ Time Frame: Up to 30 days after surgery. ]
    Rate of death due to any cause within 30 days after surgery.
  • 5. Overall survival within 2 years after surgery. [ Time Frame: Up to 2 years after surgery. ]
    Overall survival within 2 years after surgery.
  • 6. Disease-free survival within 2 years after surgery. [ Time Frame: Up to 2 years after surgery. ]
    Disease-free survival within 2 years after surgery.
  • 7. Quality of life of 2-year survivors: WHOQOL-BREF [ Time Frame: At the end of 2 years after surgery. ]
    Quality of life is assessed with with the World Health Organization quality of life scale brief version (WHOQOL-BREF).
  • 8. Cognition function of 2-year survivors. [ Time Frame: At the end of 2 years after surgery. ]
    Cognitive function is assessed with the Telephone Interview for Cognitive Status-Modified (TICS-m).
Eligibility Criteria
  • Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Age 50 years or older;

- 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:

- Severe uncontrolled hypertension (SBP>180 mmHg or diastolic blood pressure >110 mmHg);

- 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.

Contacts and Locations
Contacts
Locations

China, Beijing
Peking University First Hospital
Beijing

Sponsors and Collaborators

Peking University First Hospital

Investigators

Principal Investigator: Dong-Xin Wang, MD, PhD Peking University First Hospital

More Information