Effect of High vs. Low MAP Levels on Clinical Outcomes in Elderly Patients During Noncardiothoracic Surgery

Summary

This will be a multicentre, randomised, controlled and prospective clinical trial. All participants provided their written informed consent to participate in a randomized trial that examined the effects of low-level MAP (60-70 mmHg) vs. high-level MAP (90-100 mmHg) in elderly patients (65 or more years of age) during noncardiothoracic surgery under general anesthesia. The investigators hypothesise high-level blood presure of the intervention for reducing the incidence of post-operative complications.

Conditions

• Aging
• Surgery
• Blood Pressure
• Anesthesia
• Blood Loss, Surgical
• Postoperative Delirium

Interventions

DRUG

Urapidil

If necessary, intravenous urapidil 0.2-0.5 mg/kg when mean arterial pressure exceeded 10 mmHg of the target value, rather than more anesthesia, may be used in situations wherein sympathetic stimulation was high; yet a sufficient amount of anesthesia was being administered and bispectral index showed an adequate depth of hypnosis. Sedation was provided by a propofol infusion targeted to a BIS number of approximately 50 during general anesthesia.

DRUG

Phenylephrine

If necessary, intravenous phenylephrine 4-6 μg/kg when mean arterial pressure exceeded 10 mmHg of the target value, rather than more anesthesia, may be used in situations wherein sympathetic stimulation was high; yet a sufficient amount of anesthesia was being administered and bispectral index showed an adequate depth of hypnosis. Sedation was provided by a propofol infusion targeted to a BIS number of approximately 50 during general anesthesia.

PROCEDURE

Low-level MAP

MAP is regulated to the goal level (60-70 mmHg) during general anesthesia.

PROCEDURE

High-level MAP

MAP is regulated to the goal level (90-100 mmHg) during general anesthesia.

Sponsors & Collaborators

• West China Hospital

  collaborator OTHER

• The Affiliated Hospital Of Guizhou Medical University

  collaborator OTHER

• Taihe Hospital

  collaborator OTHER

• The Third Affiliated Hospital of Kunming Medical College.

  collaborator OTHER

• Sichuan Provincial People's Hospital

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Hu Anmin

  lead OTHER

Principal Investigators

• Hu Anmin · Jinan University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-07-31

Primary Completion

2017-07-31

Completion

2017-10-31

Countries

• China

Study Locations