Effects of Anesthesia Type on QoR-40 | NCT06423313

Studies
Effects of Anesthesia Type on QoR-40

NCT06423313

Sponsor

Zonguldak Bulent Ecevit University

Status

Completed

Last Update Posted

Apr 22, 2025Actual

Enrollment

1Actual

Phase

Not provided

Conditions

General Anesthesia
İnhalation Anesthetics
Quality of Recovery

Interventions

maintenance of anesthesia

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

Apr 2025

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

May 1, 2024Actual

Primary Completion Date

Nov 30, 2024Actual

Completion Date

Dec 31, 2024Actual

First Submitted Date

May 3, 2024

First Submission Date that Met QC Criteria

May 15, 2024

First Posted Date

May 21, 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

Apr 16, 2025

Last Update Posted Date

Apr 22, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Çağdaş Baytar, Principal Investigator, Zonguldak Bulent Ecevit UniversityPrincipal Investigator

Lead Sponsor

Zonguldak Bulent Ecevit 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

To compare the effects of total intravenous anesthesia and inhalation anesthesia used for maintenance on postoperative recovery in patients undergoing septorhinoplasty surgery under general anesthesia, using the recovery quality score (QoR-40).

Detailed Description

Not provided

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

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group TIVA			Procedure: maintenance of anesthesia
Group Inhalation			Procedure: maintenance of anesthesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
maintenance of anesthesia	Procedure	Types used to maintain anesthesia	Group Inhalation Group TIVA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
quality of recovery-40 questionnaire	measurement of recovery quality in the first 24 hours after extubation with quality of recovery-40 questionnaire. Quality of recovery-40 questionnaire scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).	up to 24 hour after surgery

Secondary Outcomes

Measure	Description	Time Frame
postoperative complications	complications that may occur in the postoperative period	up to 24 hour after surgery
duration of extubation	time between the last suture and extubation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-65 years old
ASA I-II-III risk group
Patients whose consent was obtained with an informed consent form
Patients who will undergo septorhinoplasty surgery

Exclusion Criteria:

-ASA >3
Psychiatric illness that prevents them from answering the questionnaire
Patients with a history of chronic opioid and benzodiazepine use as it may affect recovery time
Severe renal and hepatic insufficiency
Severe respiratory and cardiovascular disease
Patients with a body mass index >30 kg m2
Patients with a known history of allergy or contraindication to any of the drugs to be used in the study

Accepts Healthy Volunteers

Yes

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

The study will include intubated patients who will undergo septorhinoplasty surgery under general anesthesia, aged 18-65 years, in the American Society of Anesthesiology (ASA) I-II-III risk class.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zonguldak Bülent Ecevit University Medicine Faculty		Zonguldak	Kozlu	67600	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided