NCT07064642

Brief Summary

This retrospective study aims to compare the effects of low-flow and high-flow anesthesia techniques on intraoperative hemodynamics, neutrophil-to-lymphocyte ratio (NLR), and postoperative outcomes in patients undergoing tympanoplasty or myringoplasty. The data were collected from medical records of patients who underwent ear surgery between \[September 1, 2022\] and \[April 1, 2023\]. The study seeks to evaluate whether the choice of anesthetic flow rate has a significant impact on inflammatory response and recovery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2023

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

July 20, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

1 month

First QC Date

July 3, 2025

Last Update Submit

July 14, 2025

Conditions

Keywords

Anesthesia high-flowAnesthesia low-flowNeutrophil-lymphocyte ratioSystemic inflammatory response

Outcome Measures

Primary Outcomes (1)

  • Postoperative neutrophil-to-lymphocyte ratio (NLR)

    The neutrophil-to-lymphocyte ratio measured from blood samples taken immediately after surgery to assess the systemic inflammatory response in patients undergoing tympanoplasty or myringoplasty with low-flow or high-flow anesthesia.

    Within 1 hour postoperatively (Day 0)

Study Arms (2)

Low-flow anesthesia group

Low-flow anesthesia group 0.75 L/min : Patients who underwent tympanoplasty or myringoplasty under low-flow anesthesia technique. The anesthetic gas flow rate was maintained at low levels throughout the procedure to evaluate its effects on systemic inflammation and hemodynamics.

High-flow anesthesia group

High-flow anesthesia group 3 L/min : Patients who underwent tympanoplasty or myringoplasty under high-flow anesthesia technique. The anesthetic gas flow rate was maintained at high levels throughout the procedure to compare its impact on inflammatory response and postoperative outcomes.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This retrospective study evaluated patients who underwent tympanoplasty or myringoplasty surgery at the operating rooms of Karadeniz Technical University Faculty of Medicine between September 1, 2022, and April 1, 2023. Participants were excluded based on the following criteria: age under 18 or over 75 years, incomplete clinical data, body mass index (BMI) \<18.5 kg/m² or \>29.9 kg/m², presence of neurological disorders, and a history of renal or hepatic failure. A total of 59 patients aged between 18 and 75 years, with ASA (American Society of Anesthesiologists) physical status scores of I-III and BMI values between 18.5 and 29.9 kg/m², were initially included in the study. Following the exclusion of nine patients with missing data, the final study population consisted of 50 individuals.

You may qualify if:

  • Adults aged between 18 and 75 years
  • American Society of Anesthesiologists (ASA) physical status classification I to III
  • Body Mass Index (BMI) between 18.5 and 29.9 kg/m²

You may not qualify if:

  • Age below 18 or above 75 years
  • Incomplete or missing clinical data
  • BMI less than 18.5 kg/m² or greater than 29.9 kg/m²
  • Presence of neurological disorders
  • History of renal or hepatic failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical University Faculty of Medicine Hospital

Trabzon, Trabzon, 61080, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident Doctor in Anesthesiology, Sponsor-Investigator

Study Record Dates

First Submitted

July 3, 2025

First Posted

July 15, 2025

Study Start

July 20, 2023

Primary Completion

August 20, 2023

Study Completion

September 20, 2023

Last Updated

July 17, 2025

Record last verified: 2025-07

Locations