Carotis cFT In Prediction Of Hypotension

December 7, 2023 updated by: mediha turktan, Cukurova University

The Role of Carotis Flow Time in Prediction of Hypotension After Anesthesia Induction in Elderly Patients

The aim of our study is to determine the predictive value of pre-anesthesia FTc for hypotension that may develop after general anesthesia induction in patients over 65 years of age and to investigate the correlation between pre-anesthesia FTc and the magnitude of the maximum decrease in systolic blood pressure from the pre-anaesthetic value.

Study Overview

Detailed Description

The FTc value of the patients to be included in the study will be measured by ultrasonography 10 minutes before the induction of anesthesia.After the measurement, the patients will be monitored with 3-lead electrocardiography, pulse oximetry and noninvasive blood pressure in the operating room. Before induction of general anesthesia, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MAP), oxygen saturation and heart rate will measured for 3 minutes at 1-minute intervals. Induction of anesthesia with 1-2 mg/kg propofol, muscle relaxation will be achieved with 0.6 mg/kg intravenous rocuronium. During mask ventilation, 1-2% concentration of sevoflurane and 50-50% oxygen-nitrous oxide will be used. After the anesthesia induction, SBP, DBP, MAP, oxygen saturation and heart rate will be measured for 3 minutes at 1-minute intervals.

Hypotension; defined as a 30% reduction in SBP or a 20% reduction in MAP, or an absolute SBP below 90 mm Hg and MAP below 65 mm Hg within 3 minutes of induction of general anesthesia.Intravenous (iv) noradrenaline and/or iv crystalloid will be used in the treatment of hypotension.

Study Type

Observational

Enrollment (Actual)

138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Adana, Turkey, 01130
        • Cukurova University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients > 65 years old who will undergo elective surgery under general anesthesia will be include in the study. In the preoperative unit, the FTc value in B-mode will be measured under ultrasound guidance (Esaote, MyLab tm Six Ultrasound). After the measurement, in the operating room the patients will be monitored with 3-lead electrocardiography, pulse oximetry, and noninvasive blood pressure (Infinity Kappa monitor, GE Medical Systems, Inc, Telford, PA). Before induction of anesthesia, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MAP) and heart rate will be measured for 3 minutes at 1-minute intervals.

Anesthesia induction will be achieved with iv 1-2 mg/kg of propofol and iv 0.6 mg/kg rocuronium will be added for muscle relaxation.Sevoflurane 1-2% and 50-50% oxygen-nitrous oxide will be used during mask ventilation. After anesthesia induction, SBP, DBP, MAP and heart rate will be measured for 3 minutes at 1-minute intervals.

Description

Inclusion Criteria:

  • >65 years old
  • undergoing elective surgery under general anesthesia

Exclusion Criteria:

  • Mean arterial pressure < 70 mmHg
  • Systolic blood pressure > 180 mmHg
  • Diastolic blood pressure > 110 mmHg
  • < 65 years old
  • Carotid artery stenosis > 50%
  • ASA > 3
  • Left ventricle ejection fraction < 40%
  • Severe peripheral vascular disease
  • Implanted pacemacer
  • Autonomic nervous system disorders
  • Heart valve disease
  • Chronic kidney disease
  • Emergency surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anesthesia induction related hypotension
Time Frame: at 1 minute after anesthesia induction, at 2 minutes after anesthesia induction, at 3 minutes anesthesia induction
Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MAP) were measured 1 minute before anesthesia induction and after anesthesia induction (at 1 minute intervals for 3 minutes). Hypotension was defined as 30% decrease in SBP or a 20% decrease in MAP or absolute SBP less than 90 mm Hg, and MAP below 65 mm Hg within 3 minutes of induction of general anaesthesia.
at 1 minute after anesthesia induction, at 2 minutes after anesthesia induction, at 3 minutes anesthesia induction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2023

Primary Completion (Actual)

December 7, 2023

Study Completion (Actual)

December 7, 2023

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 9, 2023

Study Record Updates

Last Update Posted (Estimated)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Carotid cFT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypotension

Clinical Trials on ultrasound-guided carotid artery flow time measurement

3
Subscribe