Intraoperative Goal-directed Blood Pressure and Dexmedetomidine on Outcomes

Blood Pressure Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03933306
• Other study ID #: 2019-73
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 20, 2019
• Est. completion date: May 2024

Study information

• Verified date: March 2024
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 496
• Est. completion date: May 2024
• Est. primary completion date: October 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of organ injury and other complications within 30 days after surgery.	A composite endpoint including delirium, acute kidney injury, myocardial injury, and other complications after surgery.	Up to 30 days after surgery.
Secondary	Incidence of organ injury and other complications within 7 days after surgery.	A composite endpoint including delirium, acute kidney injury, myocardial injury, and other complications after surgery.	Up to 7 days after surgery.
Secondary	Length of stay in the intensive care unit after surgery.	Length of stay in the intensive care unit after surgery.	Up to 30 days after surgery.
Secondary	Length of stay in hospital after surgery.	Length of stay in hospital after surgery.	Up to 30 days after surgery.
Secondary	30-day all-cause mortality.	Rate of death due to any cause within 30 days after surgery.	Up to 30 days after surgery.
Secondary	Overall survival after surgery.	Overall survival after surgery.	Up to 3 years after surgery.
Secondary	Disease-free survival after surgery.	Disease-free survival after surgery.	Up to 3 years after surgery.
Secondary	Quality of life of 2-year survivors: WHOQOL-BREF	Quality of life is assessed with with the World Health Organization quality of life scale brief version (WHOQOL-BREF).	At the end of 2 years after surgery.
Secondary	Cognition function of 2-year survivors.	Cognitive function is assessed with the Telephone Interview for Cognitive Status-Modified (TICS-m).	At the end of 2 years after surgery.