Carotis cFT In Prediction Of Hypotension

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05896514
• Other study ID #: Carotid cFT
• Status: Completed
• Start date: June 3, 2023
• Est. completion date: December 7, 2023

Study information

• Verified date: December 2023
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: December 7, 2023
• Est. primary completion date: December 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Elderly
• Hypotension

Intervention

Device:
• ultrasound-guided carotid artery flow time measurement
Ultrasound-guided corrected carotid artery flow time will be measured before anestesia induction.

Locations

Country	Name	City	State
Turkey	Cukurova University	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anesthesia induction related hypotension	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