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Ability of Carotid Sonography and Inferior Vena Cava Sonography for the Prediction of Post-induction Hypotension in Hypertensive Patients

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ClinicalTrials.gov Identifier: NCT03986112
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
Hypertensive patients have more hemodynamic instability during general anesthesia than do patients with NORMOTENSION. In this study, the investigators evaluated the usefulness of carotid ultrasound and inferior vena cervical ultrasound for predicting hypotension after induction of anesthesia in patients with hypertension.

Condition or disease Intervention/treatment
General Anesthesia Biological: carotid sonography and inferior vena cava sonography

Detailed Description:

Carotid and venous ultrasonography is performed in a comfortable state. Corrected blood flow after carotid ultrasound and carotid artery blood flow rate were measured.

After inferior vena cava sonography, using the embedded software, the collapsibility Index by measuring the largest and smallest diameter during the respiratory cycle will be obtained.

After confirming baseline blood pressure and pulse rate, propofol 2 mg / kg is administered and remifentanil is maintained at 4.0 ng / mL using the Target Control System (TCI).

Following the administration of rocuronium 1.0-1.2 mg / kg, and 1 minute and 30 seconds after BIS 60 or less, endotracheal intubation is performed using video laryngoscope.

Blood pressure and heart rate are measured at prior to induction, 1 minute after the induction, immediately after intubation, and at 1, 3, 5, 7 and 10 minutes after intubation.

Post-induction hypotension after anesthesia induction is considered as a decrease of 20% or more of the pre-anesthesia blood pressure or a mean arterial blood pressure of less than 60 mmHg.

In the event of hypotension in accordance with the above definition, repeated administration of ephedrine 4 mg or phenylephrine 50 mcg is used.


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Study Type : Observational
Estimated Enrollment : 58 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ability of Carotid Sonography and Inferior Vena Cava Sonography for the Prediction of Post-induction Hypotension in Hypertensive Patients
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
hypertensive group
Evaluation of the ability of carotid sonography and inferior vena cava sonography for the post-induction hypotension in hypertensive patients undergoing general anesthesia
Biological: carotid sonography and inferior vena cava sonography
Carotid and venous ultrasonography is performed in a comfortable state. Corrected blood flow after carotid ultrasound and carotid artery blood flow rate were measured. After inferior vena cava sonography, the collapsibility Index by measuring the largest and smallest diameter during the respiratory cycle will be obtained. Propofol 2 mg / kg is administered and remifentanil is maintained at 4.0 ng / mL using the Target Control System. Blood pressure and heart rate are measured at prior to induction, 1 minute after induction, immediately after intubation, and at 1, 3, 5, 7 and 10 minutes after intubation. Post-induction hypotension is considered as a decrease of 20% or more of baseline blood pressure or a mean arterial blood pressure of less than 60 mmHg. In the event of hypotension in accordance with the above definition, repeated administration of ephedrine 4 mg or phenylephrine 50 mcg is used.




Primary Outcome Measures :
  1. Prediction power of the post-induction hypotension of carotid sonography and inferior vena cava sonography [ Time Frame: Prior to induction ]
    To evaluate the ability of carotid sonography and inferior vena cava sonography for the post-induction hypotension in hypertensive patients undergoing general anesthesia, blood pressure was measured 8 times below time points.

  2. Prediction power of the post-induction hypotension of carotid sonography and inferior vena cava sonography [ Time Frame: 1 minute after anesthetic induction ]
    To evaluate the ability of carotid sonography and inferior vena cava sonography for the post-induction hypotension in hypertensive patients undergoing general anesthesia, blood pressure was measured 1 minute after anesthetic induction.

  3. Prediction power of the post-induction hypotension of carotid sonography and inferior vena cava sonography [ Time Frame: Immediately after intubation ]
    To evaluate the ability of carotid sonography and inferior vena cava sonography for the post-induction hypotension in hypertensive patients undergoing general anesthesia, blood pressure was measured Immediately after intubation.

  4. Prediction power of the post-induction hypotension of carotid sonography and inferior vena cava sonography [ Time Frame: 1 minute after tracheal intubation ]
    To evaluate the ability of carotid sonography and inferior vena cava sonography for the post-induction hypotension in hypertensive patients undergoing general anesthesia, blood pressure was measured 1 minute after tracheal intubation.

  5. Prediction power of the post-induction hypotension of carotid sonography and inferior vena cava sonography [ Time Frame: 3 minutes after tracheal intubation ]
    To evaluate the ability of carotid sonography and inferior vena cava sonography for the post-induction hypotension in hypertensive patients undergoing general anesthesia, blood pressure was measured 3 minutes after tracheal intubation.

  6. Prediction power of the post-induction hypotension of carotid sonography and inferior vena cava sonography [ Time Frame: 5 minutes after tracheal intubation ]
    To evaluate the ability of carotid sonography and inferior vena cava sonography for the post-induction hypotension in hypertensive patients undergoing general anesthesia, blood pressure was measured 5 minutes after tracheal intubation.

  7. Prediction power of the post-induction hypotension of carotid sonography and inferior vena cava sonography [ Time Frame: 7 minutes after tracheal intubation ]
    To evaluate the ability of carotid sonography and inferior vena cava sonography for the post-induction hypotension in hypertensive patients undergoing general anesthesia, blood pressure was measured 7 minutes after tracheal intubation.

  8. Prediction power of the post-induction hypotension of carotid sonography and inferior vena cava sonography [ Time Frame: 10 minutes after tracheal intubation ]
    To evaluate the ability of carotid sonography and inferior vena cava sonography for the post-induction hypotension in hypertensive patients undergoing general anesthesia, blood pressure was measured 10 minutes after tracheal intubation.



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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hypertensive patients aged 19 to 80 years who are scheduled to undergo surgery under general anesthesia
Criteria

Inclusion Criteria:

  • 1) 19-80 years old hypertensive patients with ASA class I-III
  • 2) Scheduled surgery under general anesthesia

Exclusion Criteria:

  • 1) Emergency operation
  • 2) Reoperation
  • 3) Patients with history of heart failure (unstable angina, congestive heart failure, coronary artery disease)
  • 4) Patients under 40 % of Ejection faction
  • 5) Patients with history of valvular heart failure
  • 6) Patients with history of peripheral arterial occlusive disease
  • 7) Patients with history of arrhythmia (specially AV nodal block), ventricular conduction problem
  • 8) Pregnancy patients
  • 9) Patients who cannot read the consent form (examples: Illiterate, foreigner)
  • 10) Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression)
  • 11) Patients who withdraw the consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986112


Contacts
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Contact: So yeon Kim, MD +82-10-8871-2786 knnyyy@yuhs.ac

Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine Not yet recruiting
Seoul, Korea, Republic of, 03722
Contact: So Yeon Kim, MD    82-10-8871-2786    knnyyy@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03986112     History of Changes
Other Study ID Numbers: 1-2018-0064
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yonsei University:
carotid sonography
inferior vena cava sonography
hypertension
general anesthesia
predictive power

Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases