- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06423313
Effects of Anesthesia Type on QoR-40
April 16, 2025 updated by: Çağdaş Baytar, Zonguldak Bulent Ecevit University
The Comparison of Total Intravenous Anesthesia and Inhalation Anesthesia Effects on Postoperative Recovery by Quality of Recovery (QoR-40) in Septorhinoplasty
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).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kozlu
-
Zonguldak, Kozlu, Turkey, 67600
- Zonguldak Bülent Ecevit University Medicine Faculty
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability 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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group TIVA
|
Types used to maintain anesthesia
|
|
Group Inhalation
|
Types used to maintain anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
quality of recovery-40 questionnaire
Time Frame: up to 24 hour after surgery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative complications
Time Frame: up to 24 hour after surgery
|
complications that may occur in the postoperative period
|
up to 24 hour after surgery
|
|
duration of extubation
Time Frame: end of the surgery
|
time between the last suture and extubation
|
end of the surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2024
Primary Completion (Actual)
November 30, 2024
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
May 3, 2024
First Submitted That Met QC Criteria
May 15, 2024
First Posted (Actual)
May 21, 2024
Study Record Updates
Last Update Posted (Actual)
April 22, 2025
Last Update Submitted That Met QC Criteria
April 16, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/07-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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