NCT05648643

Brief Summary

Hypotension is very common during and after anesthesia induction. A prolonged fasting period, a patient's underlying comorbidities, a sympathetic blockade by anesthetic agents, vasodilation, a reduction in preload, and cardiac contractility can cause post-induction hypotension.1,2 The relationship of even short-term hypotension with myocardial damage, renal injury, and stroke has been shown in many studies; therefore, it is very important to provide stable anesthesia induction.3 In current anesthesia practice, we can only intervene when hypotension occurs. If we can identify patients who may experience hypotension during anesthesia induction before it occurs, we can prevent possible postoperative organ dysfunctions by reducing the duration and depth of hypotension with prophylactic fluid and vasopressor administration. We hypothesized that arterial elastance (Ea) values before anesthesia induction could predict post-induction hypotension. To test our hypothesis, we aimed to investigate the reliability of the Ea value, which was monitored preoperatively using the pressure analytical recording method (PRAM) to predict the risk of hypotension that may occur after anesthesia induction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

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

January 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

November 26, 2022

Last Update Submit

December 9, 2022

Conditions

Keywords

General anesthesiaArterial elastancePost-induction hypotensionMonitorization

Outcome Measures

Primary Outcomes (1)

  • Arterial elastance (Ea) measured before anesthesia induction was investigated whether is a predictive parameter for post-induction hypotension in patients undergoing general anesthesia.

    Ea ((mmHg m-2ml-1)is an indicator of cardiac afterload and arterial tone and can be calculated by the ratio of the end-systolic pressure (ESP) and stroke volume (SV) obtained from arterial wave analysis. Ea was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy) before the anesthesia induction

    The duration of the study was defined from one minute before induction to 10 minutes after induction

Secondary Outcomes (1)

  • Stroke volume variation (SVV), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia

    The duration of the study was defined from one minute before induction to 10 minutes after induction

Other Outcomes (8)

  • Pulse pressure variation (PPV), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia

    The duration of the study was defined from one minute before induction to 10 minutes after induction

  • Cardiac power output (CPO), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia

    The duration of the study was defined from one minute before induction to 10 minutes after induction

  • Cardiac index (CI), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia

    The duration of the study was defined from one minute before induction to 10 minutes after induction

  • +5 more other outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with ASA physical status 1-3 who underwent major elective surgery

You may qualify if:

  • Patients with ASA( American Society Of Anesthesiology) physical status 1-3
  • Underwent major elective surgery
  • Required intra-arterial blood pressure monitoring before induction.

You may not qualify if:

  • Under 18 years of age
  • Arrhythmia (atrial fibrillation, frequent premature beat)
  • Severe pre-existing lung disease
  • Severe valvular heart disease
  • morbid obesity
  • emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem Altunizade Hospital

Istanbul, 31190, Turkey (Türkiye)

Location

Related Publications (3)

  • Monge Garcia MI, Jian Z, Settels JJ, Hatib F, Cecconi M, Pinsky MR. Reliability of effective arterial elastance using peripheral arterial pressure as surrogate for left ventricular end-systolic pressure. J Clin Monit Comput. 2019 Oct;33(5):803-813. doi: 10.1007/s10877-018-0236-y. Epub 2018 Dec 14.

    PMID: 30552525BACKGROUND
  • Merillon JP, Ennezat PV, Guiomard A, Masquet-Gourgon C, Aumont MC, Gourgon R. Left ventricular performance is closely related to the physical properties of the arterial system: Landmark clinical investigations in the 1970s and 1980s. Arch Cardiovasc Dis. 2014 Oct;107(10):554-62. doi: 10.1016/j.acvd.2014.08.001. Epub 2014 Oct 8.

    PMID: 25304173BACKGROUND
  • Monge Garcia MI, Jian Z, Settels JJ, Hunley C, Cecconi M, Hatib F, Pinsky MR. Determinants of left ventricular ejection fraction and a novel method to improve its assessment of myocardial contractility. Ann Intensive Care. 2019 Apr 16;9(1):48. doi: 10.1186/s13613-019-0526-7.

    PMID: 30993544BACKGROUND

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

November 26, 2022

First Posted

December 13, 2022

Study Start

January 1, 2022

Primary Completion

June 30, 2022

Study Completion

August 15, 2022

Last Updated

December 13, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations