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

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.

Study Overview

• Status: Unknown
• Conditions: General Anesthesia
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 58

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hypertensive patients aged 19 to 80 years who are scheduled to undergo surgery under general anesthesia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction power of the post-induction hypotension of carotid sonography and inferior vena cava sonography	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.	Prior to induction
Prediction power of the post-induction hypotension of carotid sonography and inferior vena cava sonography	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.	1 minute after anesthetic induction
Prediction power of the post-induction hypotension of carotid sonography and inferior vena cava sonography	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.	Immediately after intubation
Prediction power of the post-induction hypotension of carotid sonography and inferior vena cava sonography	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.	1 minute after tracheal intubation
Prediction power of the post-induction hypotension of carotid sonography and inferior vena cava sonography	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.	3 minutes after tracheal intubation
Prediction power of the post-induction hypotension of carotid sonography and inferior vena cava sonography	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.	5 minutes after tracheal intubation
Prediction power of the post-induction hypotension of carotid sonography and inferior vena cava sonography	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.	7 minutes after tracheal intubation
Prediction power of the post-induction hypotension of carotid sonography and inferior vena cava sonography	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.	10 minutes after tracheal intubation

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2019
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 12, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): June 17, 2019
• Last Update Submitted That Met QC Criteria: June 13, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: hypertension; general anesthesia; carotid sonography; inferior vena cava sonography; predictive power
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 1-2018-0064

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No