NCT07003061

Brief Summary

This prospective observational study aims to evaluate the effects of sarcopenia on intraoperative neuromuscular block (NMB) in patients undergoing gastrointestinal cancer surgery. Adult patients scheduled for elective gastrointestinal cancer surgery will be grouped as sarcopenic or non-sarcopenic based on preoperative abdominal CT scans. Neuromuscular block parameters, including onset time, depth, duration, and recovery, will be objectively measured using TOF (Train-of-Four) monitoring. The study seeks to determine whether sarcopenia influences sensitivity to muscle relaxants and to contribute to individualized anesthesia management and patient safety.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2025

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

First Submitted

Initial submission to the registry

May 26, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

May 26, 2025

Last Update Submit

April 26, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Onset Time of Neuromuscular Block

    Time from administration of the muscle relaxant to achievement of adequate neuromuscular block, measured by Train-of-Four (TOF) monitoring.

    Intraoperative (from induction until adequate block is achieved)

  • Depth of Neuromuscular Block (TOF Ratio)

    Intraoperative depth of neuromuscular block, continuously monitored using TOF ratio.

    Intraoperative (from induction to end of surgery)

  • Duration of Neuromuscular Block

    Time from administration of the muscle relaxant to recovery of neuromuscular function (TOF ratio ≥ 0.9).

    Intraoperative (from muscle relaxant administration to recovery)

  • Dose and Duration of Reversal Agent

    Total dose and time required for the reversal agent to achieve recovery from neuromuscular block.

    Intraoperative (from administration of reversal agent to recovery)

Study Arms (2)

Sarcopenic

Patients with gastrointestinal cancer scheduled for elective surgery who are identified as sarcopenic based on preoperative abdominal CT scans at the L3 vertebral level, according to established cut-off values.

Procedure: Standard Anesthesia Management

Non-Sarcopenic

Patients with gastrointestinal cancer scheduled for elective surgery who are identified as non-sarcopenic based on preoperative abdominal CT scans at the L3 vertebral level, according to established cut-off values.

Procedure: Standard Anesthesia Management

Interventions

All patients will receive standard anesthesia care as per institutional protocols. No experimental intervention will be applied.

Non-SarcopenicSarcopenic

Eligibility Criteria

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

Adult patients aged 18 to 75 years who have been diagnosed with gastrointestinal cancer and are scheduled for elective surgery at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. All participants will have undergone preoperative abdominal CT scans. Both male and female patients meeting the inclusion and exclusion criteria will be eligible for enrollment.

You may qualify if:

  • Patients aged between 18 and 75 years
  • Patients diagnosed with gastrointestinal system (GIS) cancer and scheduled for elective surgery
  • Patients who have undergone preoperative abdominal computed tomography (CT) imaging
  • Patients classified as American Society of Anesthesiologists (ASA) physical status I-III

You may not qualify if:

  • Patients with a history of neuromuscular diseases
  • Patients receiving chronic steroid or immunosuppressive therapy
  • Patients with electrolyte imbalance
  • Patients using medications that affect neuromuscular transmission
  • Patients with severe organ failure in the preoperative period (e.g., liver or renal failure)
  • Patients who refuse to participate in the study
  • Patients requiring emergency surgery
  • Patients using muscle relaxants in the preoperative period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

Location

Related Publications (2)

  • Almeida PS, Barao K, Forones NM. SARCOPENIA AND GASTROINTESTINAL CANCER: NUTRITIONAL APPROACH FOCUSING ON CURCUMIN SUPPLEMENTATION. Arq Gastroenterol. 2025 Apr 4;62:e24068. doi: 10.1590/S0004-2803.24612024-068. eCollection 2025.

    PMID: 40197883BACKGROUND
  • Clark BC. Neuromuscular Changes with Aging and Sarcopenia. J Frailty Aging. 2019;8(1):7-9. doi: 10.14283/jfa.2018.35.

    PMID: 30734824BACKGROUND

MeSH Terms

Conditions

Gastrointestinal NeoplasmsSarcopenia

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Mustafa Kemal SAHIN

    Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR
  • Mensure KAYA

    Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR
  • Belkis YILMAZ

    Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR
  • Ahmet BAYRAK

    Ankara Oncology Education and Research Hospital Clinic of Radiology

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 26, 2025

First Posted

June 4, 2025

Study Start

June 1, 2025

Primary Completion

February 10, 2026

Study Completion

April 1, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

De-identified individual participant data (IPD) will be made available upon reasonable request after publication of the study results.

Locations