Tapse/Pasp General Anesthesia | NCT06414811

Studies
Tapse/Pasp General Anesthesia

NCT06414811

Sponsor

Aydin Adnan Menderes University

Status

Unknown status

Last Update Posted

Jul 30, 2024Actual

Enrollment

52Estimated

Phase

Not provided

Conditions

Hypotension

Interventions

HYPOTENSİON

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2024Actual

Primary Completion Date

Jan 15, 2025Estimated

Completion Date

Mar 15, 2025Estimated

First Submitted Date

May 10, 2024

First Submission Date that Met QC Criteria

May 10, 2024

First Posted Date

May 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2024

Last Update Posted Date

Jul 30, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

ferdi gülaştı, ASS. PROF. DR, Aydin Adnan Menderes UniversityPrincipal Investigator

Lead Sponsor

Aydin Adnan Menderes UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

TAPSE, one of the methods for evaluating right ventricular systolic function; It is a bar parameter that can easily measure apex-basal shortening and provides specific information about global RV function. TAPSE/PASP can be calculated as load-independent parameters to evaluate RV function. Because RV function is sensitive to change in afterload, known as the RV-pulmonary circulation (PC) connection.

This study aims to identify patients who are candidates for hypotensive events due to general anesthesia in a hemodynamically stable population.

Detailed Description

This study aims to identify patients who are candidates for hypotensive events due to general anesthesia in a hemodynamically stable population.

Patients will be measured by transthoracic echocardiography in the preoperative period, 15-30 minutes before induction.

Basal hemodynamic parameters and non-invasive and/or hemodynamic values will be recorded every two minutes after induction until surgical incision.Patients with a 30% decrease in SBP from the baseline and a decrease in MAP below 65 mmHg in the first 10 minutes after anesthesia induction will be considered to have hypotension. Patients will be divided into 2 groups: 'with' and 'without' hypotension.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

52Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypotension		Patients with a 30% decrease in SBP from baseline and a decrease in MAP below 65 mmHg in the first 10 minutes after anesthesia induction will be considered to have hypotension.	Other: HYPOTENSİON
none hypotension		Patients who do not have a 30% decrease from the baseline in SBP and a decrease in MAP below 65 mmHg in the first 10 minutes after anesthesia induction will be considered as not having hypotension.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HYPOTENSİON	Other	MAP below 55 mmHg or long-term (2 minutes or more) hypotensive attacks will be treated with ephedrine 0.1mg/kg.	Hypotension

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1. tension	Intraoperative systolic arterial tension, diastolic arterial tension and mean arterial tension will be taken and recorded for the patients.	4-5 hours]

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent;
18-75 years old
ASA Physical Status 1-3;
Patients planned for surgery

Exclusion Criteria:

The patient is pregnant
After cardiac surgery
Severe pulmonary hypertension
Severe valve disease
Hypertrophic or dilated cardiomyopathy
Presence of acute myocardial infarction
Patients with severe visual or hearing impairment/disability
ASA physical status IV or V
Ischemic heart disease, conduction disorder.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

ASA1-3 patients aged 18-75 who will undergo elective surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ferdi gülaştı	Contact	+905054929650		ferdigulasti@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ferdi Gülaştı	Recruiting	Aydin		09020	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D007022	Hypotension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007023	Hypotension, Controlled
D013812	Therapeutics

Ancestor Terms

ID	Term
D000760	Anesthesia and Analgesia

Browse Leaves

Not provided

Browse Branches

Not provided