NCT06423313

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2024

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

May 1, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 21, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

May 3, 2024

Last Update Submit

April 16, 2025

Conditions

Keywords

total intravenous anesthesiaanesthesia maintenanceinhalation anesthesiaquality of recovery-40

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • postoperative complications

    up to 24 hour after surgery

  • duration of extubation

    end of the surgery

Study Arms (2)

Group TIVA

Procedure: maintenance of anesthesia

Group Inhalation

Procedure: maintenance of anesthesia

Interventions

Types used to maintain anesthesia

Group InhalationGroup TIVA

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit University Medicine Faculty

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 3, 2024

First Posted

May 21, 2024

Study Start

May 1, 2024

Primary Completion

November 30, 2024

Study Completion

December 31, 2024

Last Updated

April 22, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations