NCT03986112

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

June 17, 2019

Status Verified

June 1, 2019

Enrollment Period

10 months

First QC Date

June 12, 2019

Last Update Submit

June 13, 2019

Conditions

Keywords

carotid sonographyinferior vena cava sonographyhypertensiongeneral anesthesiapredictive power

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (1)

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

Interventions

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.

hypertensive group

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

So yeon Kim, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2019

First Posted

June 14, 2019

Study Start

July 1, 2019

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

June 17, 2019

Record last verified: 2019-06

Locations