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Intraoperative Goal-directed Blood Pressure and Dexmedetomidine on Outcomes

NCT03933306 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 496

Last updated 2025-07-18

No results posted yet for this study

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

Interventions

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.

DRUG

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.

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.

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Dong-Xin Wang, MD, PhD · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-20
Primary Completion
2020-10-29
Completion
2024-05-30

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03933306 on ClinicalTrials.gov