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

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03986112
• Other study ID #: 1-2018-0064
• Status: Not yet recruiting
• Start date: July 2019
• Est. completion date: May 2020

Study information

• Verified date: June 2019
• Source: Yonsei University
• Contact: So yeon Kim, MD
• Phone: +82-10-8871-2786
• Email: knnyyy[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• General Anesthesia
• Hypotension

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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