Intraoperative Goal-directed Blood Pressure and Dexmedetomidine on Outcomes

NCT03933306 | Completed Phase 4 DMC

• 1 other identifier: 2019-73
• Study Type: interventional
• Target: 496
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

blood pressure management; dexmedetomidine; high-risk patients; abdominal surgery; postoperative organ injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Incidence of organ injury and other complications within 7 days after surgery.

  Up to 7 days after surgery.

• Length of stay in the intensive care unit after surgery.

  Up to 30 days after surgery.

• Length of stay in hospital after surgery.

  Up to 30 days after surgery.

• 30-day all-cause mortality.

  Up to 30 days after surgery.

• Overall survival after surgery.

  Up to 3 years after surgery.

Study Arms (4)

Placebo+routine blood pressure management

PLACEBO COMPARATOR

Placebo (normal saline) is administered during anesthesia. Blood pressure is managed according to routine practice.

Drug: Placebo; Other: Routine blood pressure management

Dexmedetomidine+routine blood pressure management

EXPERIMENTAL

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; Other: Routine blood pressure management

Placebo+goal-directed blood pressure management

EXPERIMENTAL

Placebo (normal saline) is administered during anesthesia. Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.

Drug: Placebo; Other: Goal-directed blood pressure management

Dexmedetomidine+goal-directed blood pressure management

EXPERIMENTAL

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; Other: Goal-directed blood pressure management

Interventions

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.

Also known as: Dexmedetomidine hydrochloride injection

Dexmedetomidine+goal-directed blood pressure management; Dexmedetomidine+routine blood pressure management

Placebo DRUG

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

Also known as: Normal saline

Placebo+goal-directed blood pressure management; Placebo+routine blood pressure management

Goal-directed blood pressure management OTHER

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

Dexmedetomidine+goal-directed blood pressure management; Placebo+goal-directed blood pressure 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.

Dexmedetomidine+routine blood pressure management; Placebo+routine blood pressure management

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

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MeSH Terms

Conditions

Postoperative Complications

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: For dexmedetomidine infusion, all the participants, care providers, investigators, outcomes assessors are masked. For blood pressure management, care providers, namely anesthesiologists, are not masked.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anaesthesiology and Critical Care Medicine

Model Details: This is a 2x2 factorial trial

Study Record Dates

• First Submitted: April 27, 2019
• First Posted: May 1, 2019
• Study Start: May 20, 2019
• Primary Completion: October 29, 2020
• Study Completion: May 30, 2024
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)