## Protocol Section
### Identification Module
**NCT ID:** NCT06423313

**Brief Title:** Effects of Anesthesia Type on QoR-40

**Official Title:** The Comparison of Total Intravenous Anesthesia and Inhalation Anesthesia Effects on Postoperative Recovery by Quality of Recovery (QoR-40) in Septorhinoplasty

#### Organization Study ID Info
**ID:** 2024/07-1
#### Organization
**Class:** OTHER
**Full Name:** Zonguldak Bulent Ecevit University
### Status Module
#### Completion Date
**Date:** 2024-10-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-08-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-03
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Zonguldak Bulent Ecevit University

#### Responsible Party

**Investigator Affiliation:** Zonguldak Bulent Ecevit University

**Investigator Full Name:** Çağdaş Baytar

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### 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).

### Conditions Module

**Conditions:**

- General Anesthesia

- İnhalation Anesthetics

- Quality of Recovery

**Keywords:**

- total intravenous anesthesia

- anesthesia maintenance

- inhalation anesthesia

- quality of recovery-40

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 1

**Type:** ACTUAL

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 1 Day

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Procedure: maintenance of anesthesia

**Label:** Group TIVA

#### Arm Group 2

**Intervention Names:**

- Procedure: maintenance of anesthesia

**Label:** Group Inhalation

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group Inhalation

- Group TIVA

**Description:** Types used to maintain anesthesia

**Name:** maintenance of anesthesia

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** measurement of recovery quality in the first 24 hours after extubation

**Measure:** quality of recovery-40 questionnaire

**Time Frame:** up to 24 hour after surgery

#### Secondary Outcomes

**Description:** complications that may occur in the postoperative period

**Measure:** postoperative complications

**Time Frame:** up to 24 hour after surgery

**Description:** time between the last suture and extubation

**Measure:** duration of extubation

**Time Frame:** end of the surgery

### 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

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Zonguldak

**Country:** Turkey

**Facility:** Zonguldak Bülent Ecevit University Medicine Faculty

**State:** Kozlu

**Zip:** 67600

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012120

- Term: Respiration Disorders

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M27137

- Name: Respiratory Aspiration

- Relevance: HIGH

- As Found: Inhalation

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000053120

- Term: Respiratory Aspiration

### Intervention Browse Module - Ancestors

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: HIGH

- As Found: Imaging

- ID: M4854

- Name: Benzocaine

- Relevance: LOW

- As Found: Unknown

- ID: T433

- Name: Tannic Acid

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000777

- Term: Anesthetics

### Misc Info Module

- Version Holder: 2024-05-31
