NCT06889714

Brief Summary

After obtaining ethical approval, 42 patients with American Society of Anesthesiologists (ASA) scores I-III who were scheduled for surgery under general anesthesia were included in our prospective study. Patients were monitored in the preoperative preparation room in the operating room and frailty was assessed using the FRAIL scale and sarcopenia was assessed using the STAR ratio. The thickness of the rectus femoris and vastus intermedius muscles of the patients was measured and recorded by ultrasonography. Thigh lengths were measured and recorded. Rectus Femoris/Thigh Length (RF/B), Vastus Intermedius/Thigh Length (VI/B), and Total Muscle Thickness/Thigh Length (T/B) were calculated and recorded. Patients were followed up according to the Modified Aldrete Score after surgery in the anesthesia recovery unit, and the time to reach 9-10 points was recorded, and the time to leave the recovery unit was recorded. Postoperatively, complications were followed up according to the Clavien-Dindo Classification, and discharge times from the hospital were recorded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

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 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 21, 2025

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

March 17, 2025

Last Update Submit

March 24, 2025

Conditions

Keywords

geriatric anesthesiasarcopeniaultrasonographypostoperative complicationsquadriceps femoris

Outcome Measures

Primary Outcomes (16)

  • age

    years old

    1 year

  • sex

    female, male

    1 year

  • height

    meter

    1 year

  • body weight

    kg

    1. year

  • educational status

    primary school graduate, middle school graduate, high school graduate, university graduate

    1 year

  • marital status

    married, single, widowed

    1 year

  • ASA score

    American Society of Anesthesiologists' Classification (ASA 1,2,3,4,5)

    1 year

  • rectus femoris muscle thickness

    cm

    1 year

  • vastus intermedius(VI) thickness

    cm

    1 year

  • rectus femoris-to-thigh length ratio

    ratio

    1 year

  • vastus intermedius-thigh length ratio

    ratio

    1 year

  • total muscle thickness to thigh length ratio

    ratio

    1 year

  • frailty score

    0-NORMAL, 1-2 PRE-FRAİL, 3-5 FRAİL

    1 year

  • recovery time from anesthesia

    minutes

    1 year

  • hospital discharge time

    days

    1 year

  • Modified Clavien-Dindo Classification

    1, 2, 3A, 3B, 4A, 4B, 5

    1 year

Interventions

Right thigh length (between the right femur greater trochanter and patella) was measured and recorded while the patients were lying supine. A linear transducer (Philips Affiniti 50, Philips Medical Systems, Seattle, WA, United States) was used for ultrasonographic measurements. The rectus femoris (RF) and vastus intermedius (VI) were visualized with the feather-touch technique after a generous amount of ultrasound gel was sprayed in the center of the right thigh, and the thickness of the muscles was determined and recorded using ultrasonography software. After these measurements, the rectus femoris-to-thigh length ratio (RF/B), vastus intermedius-to-thigh length ratio (VI/B), and total muscle thickness-to-thigh length ratio (T/B) were calculated and recorded.

Eligibility Criteria

Age60 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailsall genders were accepted to the study without gender discrimination
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

42 patients over 60 years of age with ASA score I-III who were to undergo colorectal malignancy surgery under general anesthesia

You may qualify if:

  • patients over 60 years of age who are undergoing colorectal malignancy surgery under general anesthesia
  • patients willing to participate in the study
  • Patients with ASA score I-III

You may not qualify if:

  • Patients with Parkinson's disease,
  • Alzheimer's disease,
  • history of cerebrovascular events,
  • neuromuscular disease,
  • cognitive dysfunction,
  • severe liver disease,
  • severe heart disease,
  • impaired cooperation due to kidney disease,
  • emergency and trauma patients,
  • patients with bilateral lower extremity amputations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Eskisehir Osmangazi

Eskişehir, Odunpazarı, 26040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

FrailtySarcopeniaPostoperative Complications

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • ferda yaman, Assoc prof

    University of Eskişehir Osmangazi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 17, 2025

First Posted

March 21, 2025

Study Start

July 20, 2023

Primary Completion

July 20, 2024

Study Completion

July 20, 2024

Last Updated

March 27, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations