A Comparison of Volatile Anesthesia and Total Intravenous... | NCT04773002

Studies
A Comparison of Volatile Anesthesia and Total Intravenous Anesthesia (TIVA)

NCT04773002

Sponsor

Tokat Gaziosmanpasa University

Status

Completed

Last Update Posted

Mar 16, 2022Actual

Enrollment

52Actual

Phase

Not provided

Conditions

Rhinoplasty
Ecchymosis
Edema
Hemorrhage

Interventions

Different anesthesia methods

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

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 18, 2021Actual

Primary Completion Date

Aug 21, 2021Actual

Completion Date

Aug 21, 2021Actual

First Submitted Date

Feb 23, 2021

First Submission Date that Met QC Criteria

Feb 23, 2021

First Posted Date

Feb 26, 2021Actual

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

Mar 15, 2022

Last Update Posted Date

Mar 16, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

In this study, investigators wanted to investigate the effect of volatile anesthesia and total intravenous anesthesia (TIVA) on ecchymosis, edema, and intraoperative bleeding in rhinoplasty.

Detailed Description

Routine monitorization (blood pressure, pulse, oxygen saturation with pulse oximetry and electrocardiogram) will be applied to all patients taken into the operation room.

In Group P (TIVA), induction of anesthesia will be achieved with 2 mg/kg propofol, 0.6 mg/kg rocuronium, and 1 μ / kg fentanyl. Propofol and remifentanil will be used in the continuation of anesthesia.

In Group S (Volatile), anesthesia will be induced with 2 mg / kg propofol, 0.6 mg / kg rocuronium and 1 μ / kg fentanyl. 50% nitrous oxide + 50% oxygen and 2% sevoflurane will be used in the continuation of anesthesia.

All patients will receive 2 ml/kg/hour Ringer's lactate solution during the operation.

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

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group P		Total intravenous anesthesia (TIVA)	Other: Different anesthesia methods
Group S		Volatile anestesia	Other: Different anesthesia methods

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Different anesthesia methods	Other	Total intravenous anesthesia (TIVA)and volatile anesthesia	Group P Group S

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Edema and ecchymosis in rhinoplasty according to the type of anesthesia.	It is evaluation developing edema and ecchymosis according to total intravenous anesthesia and volatile anesthesia in rhinoplasty.	one time in six months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Between 18 and 65 years
Planned to rhinoplasty
An American Society of Anesthesiologists score of 1 or 2

Exclusion Criteria:

Steroid use
Patients with coagulation disorders, •Rejected to participation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Rhinoplasty patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Muzaffer Katar	Gaziosmanpasa university	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gaziosmanpasa University		Tokat Province		60200	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D004438	Ecchymosis
D004487	Edema
D006470	Hemorrhage

Ancestor Terms

ID	Term
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided