Intraoperative Goal-directed Blood Pressure and Dexmedetomidine on Outcomes

March 11, 2024 updated by: Dong-Xin Wang, Peking University First Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

496

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Normal saline
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: 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.
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.
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 Names:
  • Dexmedetomidine hydrochloride injection
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 Names:
  • Normal saline
Other: Goal-directed blood pressure management
Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
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 Names:
  • Dexmedetomidine hydrochloride injection
Other: Goal-directed blood pressure management
Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 30 days after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay in hospital after surgery.
Time Frame: Up to 30 days after surgery.
Length of stay in hospital after surgery.
Up to 30 days after surgery.
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.
Up to 7 days after surgery.
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.
Up to 30 days after surgery.
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.
Up to 30 days after surgery.
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).
At the end of 2 years after surgery.
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).
At the end of 2 years after surgery.
Overall survival after surgery.
Time Frame: Up to 3 years after surgery.
Overall survival after surgery.
Up to 3 years after surgery.
Disease-free survival after surgery.
Time Frame: Up to 3 years after surgery.
Disease-free survival after surgery.
Up to 3 years after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2019

Primary Completion (Actual)

October 29, 2020

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

April 27, 2019

First Submitted That Met QC Criteria

April 30, 2019

First Posted (Actual)

May 1, 2019

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-73

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Complications

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe