Effect of Continuous Invasive Blood Pressure Monitoring on Postinduction Hypotension in Patients Having Major Surgery

The Effect of Continuous Invasive Arterial Blood Pressure Monitoring on Postinduction Hypotension in Patients Having Major Surgery (AWAKE Trial): a Randomized Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04894019

Enrollment

242

Registered

2021-05-20

Start date

2021-05-16

Completion date

2021-11-23

Last updated

2021-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Perioperative Hypotension, Postinduction Hypotension

Brief summary

This is a randomized trial (1) investigating whether continuous invasive arterial blood pressure monitoring using an arterial catheter reduces the area under a mean arterial pressure (MAP) of 65 mmHg within the first 15 minutes of anesthetic induction compared to intermittent arterial blood pressure monitoring using oscillometry in patients having major surgery under general anesthesia; and (2) investigating the effect of continuous invasive arterial blood pressure monitoring using an arterial catheter on cardiac output, stroke volume, and heart rate within the first 15 minutes of anesthetic induction compared to intermittent blood pressure monitoring using upper-arm cuff oscillometry in patients having major surgery under general anesthesia.

Detailed description

not provided

Interventions

DEVICEContinuous invasive blood pressure monitoring

Continuous invasive blood pressure monitoring using an arterial catheter

DEVICEIntermittent non-invasive blood pressure monitoring

Intermittent non-invasive blood pressure monitoring using upper-arm cuff oscillometry

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients... * at least 18 years of age * scheduled for elective major surgery under general anesthesia that requires continuous invasive arterial blood pressure monitoring using a radial arterial catheter for clinical indications not related to the study

Exclusion criteria

* Clinical indication to insert the arterial catheter before anesthetic induction (awake arterial catheter; this is usually the case in patients with severe cardiovascular diseases, such as heart failure or left ventricular assist device) * emergency surgery * American Society of Anesthesiologists physical status classification V or VI * need for femoral artery catheterization * heart rhythms other than sinus rhythm.

Design outcomes

Primary

Measure	Time frame
Area under a MAP of 65 mmHg within the first 15 minutes of anesthetic induction between the intervention and the control group.	during the induction period

Secondary

Measure	Time frame
Effect of continuous invasive arterial blood pressure monitoring on cardiac output within the first 15 minutes of anesthetic induction between the intervention and the control group.	during the induction period
Effect of continuous invasive arterial blood pressure monitoring on stroke volume within the first 15 minutes of anesthetic induction between the intervention and the control group.	during the induction period
Effect of continuous invasive arterial blood pressure monitoring on heart rate within the first 15 minutes of anesthetic induction between the intervention and the control group.	during the induction period

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026