NCT05155514

Brief Summary

Hypertension is a disease with increasing and serious complications all over the world. In particular, the incidence of hypertension increases with advancing age. Secondary problems that can be caused by hypertension include peripheral vascular diseases, arteriosclerosis, increased risk of heart attack and stroke. It is a measurement of pulse wave velocity (PWV), a non-invasive indicator of arterial stiffness. It is known that sudden hemodynamic changes that occur during the induction of anesthesia cause undesirable intraoperative and postoperative complications. It is known that arterial stiffness, which is more common in elderly patients, causes orthostatic hypotension in particular. For this reason, more hemodynamic instability may be seen in the general anesthesia procedure in elderly patients with increased arterial stiffness. In our study, we aimed to investigate whether the hemodynamic changes observed during anesthesia induction in hypertensive elderly patients, whom we think have a high pulse wave velocity, are different from normotensive patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 13, 2021

Completed
Last Updated

December 13, 2021

Status Verified

December 1, 2021

Enrollment Period

1 year

First QC Date

December 3, 2021

Last Update Submit

December 3, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Difference between hemodynamic values

    The difference between the hemodynamic values measured preoperatively and during anesthesia induction was calculated. In addition, ≥20% decrease in preoperative hemodynamic value and/or systolic blood pressure ≤90 mmHg hypotension, ≥20% increased hypertension

    Basal measurement before induction of anesthesia, then at 1-minute intervals until after endotracheal intubation

Study Arms (2)

Group H

Hypertension group (Group H): * Patients with a previous diagnosis of hypertension * Patients receiving antihypertensive therapy * Systolic blood pressure (SBP) ≥140mmHg and/or diastolic blood pressure (DBP) ≥90mmHg

Procedure: Mobil-O-Graph PWA

Group N

Normotensive group (Group N): Other non-hypertensive patients

Procedure: Mobil-O-Graph PWA

Interventions

After resting in a quiet room preoperatively, blood pressure was measured on the right arm using an oscillometric method.

Group HGroup N

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All Patients aged 50 and over

You may qualify if:

  • According to the American Society of Anesthesiologists (ASA), physical condition I-II,
  • Elective otolaryngology surgery with endotracheal intubation planned
  • Patients aged 50 and over

You may not qualify if:

  • Hypersensitivity to drugs
  • Difficult intubation history
  • Diabetes mellitus receiving insulin therapy
  • Chronic renal failure or end-stage renal disease
  • Heart failure (left ventricular ejection fraction ≤30%)
  • Valve disease (moderate to severe)
  • Atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydın Adnan Menderes University Faculty of Medicine, Department of Anesthesiology and Reanimation

Aydin, 09100, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 3, 2021

First Posted

December 13, 2021

Study Start

November 1, 2018

Primary Completion

November 1, 2019

Study Completion

November 1, 2020

Last Updated

December 13, 2021

Record last verified: 2021-12

Locations