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Clinical Trials in Turkey / NCT05993481
Enrolling by invitation Not applicable

The Noninvasive Blood Pressure Measurement Effect on the Hypotension

NCT05993481 · tracked via the Priya Life Science Turkey tracker
Sponsor
Konya City Hospital
Phase
Not applicable
Started
2024-10-25
Last updated
2025-12-29

Condition(s) studied

Hypotension During Surgery

Investigational drug(s) / intervention(s)

Blood Pressure Measurement

Blood Pressure Measurement: NIBP measurements will be recorded intraoperatively every 2.5 minutes for the group of 2.5 min. Blood pressure management or every 5 minutes for the other group of 5 min. Blood pressure management after providing randomization before the surgery. A calibrated and time-matched same type of standard anesthetic monitor will be used. The monitor will measure blood pressure and display the mean, systolic and diastolic values. All blood pressure measurements will be discontinued before the PACU transfer. Data will be automatically downloaded from the monitor to a computer using a software interface program.

Study summary

Around 300 million surgical operations are performed globally, and of these, 40 to 50 million are performed in the USA. The perioperative period is characterized by hemodynamic instability and, most importantly, hypotension. Intraoperative hypotension is frequent, and the incidence ranges between 5% and 99% during non-cardiac surgery, depending on the definition.

The aim of the study is determined as the relationship between two different time intervals of measurements and time spent hypotensive under harm thresholds in non-cardiac surgery in adults having non-cardiac surgery. Secondarily, it will be determined if more frequent non-invasive blood pressure measurement use decreases postoperative acute kidney injury. Exploratory, it will be evaluated if more frequent non-invasive blood pressure use causes pain or nerve injury in the arms or not.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 1. Age \> 18 years; 2. ASA Physical Status 1 and 3; 3. Non-cardiac surgery with expected surgery duration ≥ 2 hours; 4. Supine position during the surgery; 5. Regional or general anesthesia; 6. Planned hospital stay time of at least 24 hours. Exclusion Criteria: 1. Patients who confirm to be pregnant and/or nursing mothers; 2. Patients with an intra-aortic balloon pump (IABP) or ventricular assist device(s); 3. Has a condition that precludes routine or tight blood pressure management; 4. Mean arterial blood pressure differences between right and left arm ≥ 5 mmHg; 5. Patient who has physically disabled their arms: 5\. Emergency surgery.

Primary outcome measure(s)

  • The time-average spend hypotensive (under MAP thresholds of 65 mmHg) for at least 1 minute — Every 2.5 minute in the surgery upto end of the surgery.
    For the primary outcome, clinically important difference will be the time-average spend hypotensive (under MAP thresholds of 65 mmHg) for at least 1 minute since it has been shown clinically important in previous studies . We will assess this primary outcome in adults having non-cardiac surgery, a 2.5-minute interval of intraoperative blood measurement group compared to the standard 5-minute interval group.

Trial sites (1)

FacilityCityRegionStatus
Konya City Hospital Konya Meram

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05993481 on ClinicalTrials.gov ↗ ← All trials in Turkey