Intraoperative Goal-directed Blood Pressure and Dexmedetomidine on Outcomes

Phase 4

Active, not recruiting

• Conditions: High-risk Patients; Abdominal Surgery; Dexmedetomidine; Postoperative Complications; Blood Pressure
• Interventions: Drug: Placebo; Drug: Dexmedetomidine; Other: Routine blood pressure management; Other: Goal-directed blood pressure management

• Registration Number: NCT03933306
• Lead Sponsor: Peking University First Hospital

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.

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 Timeline

• Study First Submitted: 2019-04-27
• Study First Submitted QC: 2019-04-30
• Study First Posted: 2019-05-01
• Study Start: 2019-05-20
• Primary Completion: 2020-10-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 496

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo+routine blood pressure management	Placebo	Placebo (normal saline) is administered during anesthesia. Blood pressure is managed according to routine practice.
Placebo+routine blood pressure management	Routine blood pressure management	Placebo (normal saline) is administered during anesthesia. Blood pressure is managed according to routine practice.
Dexmedetomidine+routine blood pressure management	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.
Placebo+goal-directed blood pressure management	Placebo	Placebo (normal saline) is administered during anesthesia. Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
Placebo+goal-directed blood pressure management	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.
Dexmedetomidine+goal-directed blood pressure management	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+routine blood pressure management	Dexmedetomidine	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+goal-directed blood pressure management	Dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
Incidence of organ injury and other complications within 30 days after surgery.	Up to 30 days after surgery.	A composite endpoint including delirium, acute kidney injury, myocardial injury, and other complications after surgery.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China