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NCT Number: NCT03933306

Intraoperative Goal-directed Blood Pressure and Dexmedetomidine on Outcomes

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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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

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

Placebo

Drug

Loading dose placebo administered before anesthesia induction, followed by a continuous infusion until 1 hour before the end of surgery.

Other names: Normal saline

Goal-directed blood pressure management

Other

Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.

Routine blood pressure management

Other

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.

Primary outcomes

  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 outcomes

  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 after surgery.

    Time frame: Up to 3 years after surgery.

    Overall survival after surgery.

  6. Disease-free survival after surgery.

    Time frame: Up to 3 years after surgery.

    Disease-free survival after surgery.

  7. Quality of life of 3-year survivors: WHOQOL-BREF

    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).

  8. Cognition function of 3-year survivors.

    Time frame: At the end of 3 years after surgery.

    Cognitive function is assessed with the Telephone Interview for Cognitive Status-Modified (TICS-m).

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2024
First posted
May 1, 2019
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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