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HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients Undergoing Major Abdominal Surgery

NCT05637606 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 636

Last updated 2025-06-11

No results posted yet for this study

Summary

This study is a multicenter randomized controlled trial comparing two strategies of mean arterial blood pressure management (MAP ≥ 80mmHg vs MAP ≥ 65 mmHg) in high-risk surgical patients undergoing elective laparotomic/laparoscopic surgery.

Conditions

  • Blood Pressure
  • Complication,Postoperative
  • Intraoperative Hypotension

Interventions

DRUG

Ephedrine

In both the group, the target MAP can be maintained by means of bolus of ephedrine (2.5 mg). The maximal dose for the ephedrine allowed is 25 mg (10 boluses of 2.5 mg), after this threshold a continuous infusion of norepinephrine will be started

DRUG

Norepinephrine

In both the group, the target MAP can be maintained by means of bolus of ephedrine (2.5 mg) or Etilefrine (1 mg). The continuous infusion of norepinephrine, as decided by the attending anesthetist, may be started at any point of the intraoperative period. The starting dose of norepinephrine is the lowest needed to reach the predefined MAP target.

DRUG

Etilefrine Hydrochloride bolus

The maximal dose for the etilefrine allowed is 10 mg (10 boluses of 1 mg), after this threshold a continuous infusion of norepinephrine will be started

DIAGNOSTIC_TEST

Use of pulse pressure and stroke volume variation (PPV and SVV); use of Mini Fluid Challenge (mini_FC)

PPV, SVV and mini\_FC will guide fluid bolus administration during an episode of intraoperative hypotension, following two predefined algorithms for laparotomic/non laparotomic surgery

Sponsors & Collaborators

  • Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva

    collaborator OTHER

  • Humanitas Clinical and Research Center

    lead OTHER

Principal Investigators

  • Antonio Messina · Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milano, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-06
Primary Completion
2025-05-21
Completion
2025-05-21

Countries

  • Italy

Study Locations

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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 NCT05637606 on ClinicalTrials.gov