- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05896514
Carotis cFT In Prediction Of Hypotension
The Role of Carotis Flow Time in Prediction of Hypotension After Anesthesia Induction in Elderly Patients
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: mediha türktan
- Phone Number: 05056319446
- Email: mediturktan@gmail.com
Study Locations
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Adana, Turkey, 01130
- Cukurova University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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
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
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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
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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