The Noninvasive Blood Pressure Measurement Effect on the Hypotension

NCT05993481 | Enrolling By Invitation DMC

• 1 other identifier: Study Interval
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypotension During Surgery

Keywords

Intraoperative Hypotension; Noninvasive Blood pressure measurement; More frequent time interval

Outcome Measures

Primary Outcomes (1)

• The time-average spend hypotensive (under MAP thresholds of 65 mmHg) for at least 1 minute

  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.

  Every 2.5 minute in the surgery upto end of the surgery.

Secondary Outcomes (1)

• the time-average spend hypotensive (under MAP thresholds of <60, <50, and <40 mmHg [mmHg]) for at least 1 minute.

  Every 2.5 minute in the surgery upto end of the surgery.

Other Outcomes (1)

• Postoperative complications after surgery including acute myocardial infarction, acute kidney injury, non-fatal cardiac arrest, peripheral nerve injuries, arm pain and death and delrium status.

  Postoperative time until 24th hours.

Study Arms (2)

5 min. BP

ACTIVE COMPARATOR

Clinicians will carry out randomized treatments in coordination with research staff. The treatments will be: 1) Ephedrine treatment to maintain intraoperative MAP ≥60 mmHg, delayed resumption of chronic antihypertensive medications as monitoring with 5 min. Blood pressure management. The staff anesthesiologist will administer an ephedrine sulfate injection. An initial dose of 5 to 10 mg given as an intravenous bolus is advised for the treatment of clinically significant hypotension during anesthesia to provide an increase in blood pressure in case of MAP\< 60 mmHg. However, the dose of each will be titrated as necessary to reach the target mean arterial pressures.

Diagnostic Test: Blood Pressure Measurement

2.5 min. BP

ACTIVE COMPARATOR

Clinicians will carry out randomized treatments in coordination with research staff. The treatments will be: 2) Ephedrine treatment to maintain intraoperative MAP ≥60 mmHg, delayed resumption of chronic antihypertensive medications as monitoring with 2.5 min. Blood pressure management. The staff anesthesiologist will administer an ephedrine sulfate injection. An initial dose of 5 to 10 mg given as an intravenous bolus is advised for the treatment of clinically significant hypotension during anesthesia to provide an increase in blood pressure in case of MAP\< 60 mmHg. However, the dose of each will be titrated as necessary to reach the target mean arterial pressures.

Diagnostic Test: Blood Pressure Measurement

Interventions

Blood Pressure Measurement DIAGNOSTIC_TEST

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.

2.5 min. BP; 5 min. BP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years;
• ASA Physical Status 1 and 3;
• Non-cardiac surgery with expected surgery duration ≥ 2 hours;
• Supine position during the surgery;
• Regional or general anesthesia;
• Planned hospital stay time of at least 24 hours.

You may not qualify if:

• Patients who confirm to be pregnant and/or nursing mothers;
• Patients with an intra-aortic balloon pump (IABP) or ventricular assist device(s);
• Has a condition that precludes routine or tight blood pressure management;
• Mean arterial blood pressure differences between right and left arm ≥ 5 mmHg;
• Patient who has physically disabled their arms:
• \. Emergency surgery.

Sponsors & Collaborators

• Konya City Hospital: lead
• The Cleveland Clinic: collaborator
• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: collaborator

Study Sites (1)

Konya City Hospital

Konya, Meram, 42140, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Blood Pressure Determination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Physical Examination

Study Officials

• Yasin Tire, Assoc. Prof.

  Konya City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr. Yasin Tire

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 15, 2023
• Study Start: October 25, 2024
• Primary Completion (Estimated): November 25, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

TU (1)