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Completed

NCT Number: NCT05896514

Carotis cFT In Prediction Of Hypotension

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cukurova University

Adana, 01130, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultrasound-guided carotid artery flow time measurement

Device

Ultrasound-guided corrected carotid artery flow time will be measured before anestesia induction.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 9, 2023
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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