Sarcopenia and Neuromuscular Block in Gastrointestinal Cancer Surgery

NCT ID: NCT07003061

Last Updated: 2025-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-01

Study Completion Date

2025-09-20

Brief Summary

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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.

Detailed Description

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Sarcopenia, characterized by the loss of skeletal muscle mass and function, is a significant clinical parameter affecting both prognosis and perioperative management in patients with gastrointestinal (GI) cancer. It may alter the pharmacokinetic and pharmacodynamic properties of anesthetic agents, particularly neuromuscular blocking agents. This prospective observational study will be conducted at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital between June 1, 2025, and September 1, 2025.

Adult patients (aged 18 and above) scheduled for elective GI cancer surgery who have undergone preoperative abdominal computed tomography (CT) will be included. Patients with neuromuscular diseases, those on chronic steroid or immunosuppressive therapy, or those with significant organ failure will be excluded. Preoperative CT images at the L3 vertebral level will be evaluated by a radiologist to determine sarcopenia status, and patients will be divided into sarcopenic and non-sarcopenic groups according to established cut-off values.

All patients will receive standard anesthesia monitoring, including TOF (Train-of-Four) neuromuscular monitoring. The study will not alter any treatment protocols. After administration of muscle relaxants during anesthesia induction, neuromuscular block parameters such as onset time, depth, duration, need for reversal agents, and recovery time will be recorded. Demographic data, comorbidities, laboratory findings, type of surgery, and details of muscle relaxant use will also be collected.

The primary objective is to compare intraoperative neuromuscular block parameters between sarcopenic and non-sarcopenic patients. Statistical analysis will be performed using appropriate parametric or non-parametric tests for continuous variables and chi-square tests for categorical variables. The study aims to provide evidence for individualized dosing of muscle relaxants and to improve patient safety in anesthesia practice for GI cancer surgery.

Conditions

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Gastrointestinal Cancer Sarcopenia Neuromuscular Blockade

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Standard Anesthesia Management

Intervention Type PROCEDURE

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

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.

Standard Anesthesia Management

Intervention Type PROCEDURE

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

Interventions

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Standard Anesthesia Management

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mustafa Kemal ŞAHİN

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mustafa Kemal SAHIN

Role: PRINCIPAL_INVESTIGATOR

Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation

Mensure KAYA

Role: PRINCIPAL_INVESTIGATOR

Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation

Belkis YILMAZ

Role: PRINCIPAL_INVESTIGATOR

Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation

Ahmet BAYRAK

Role: PRINCIPAL_INVESTIGATOR

Ankara Oncology Education and Research Hospital Clinic of Radiology

Locations

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

Ankara, Yenimahalle, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Mustafa Kemal SAHIN

Role: CONTACT

+905075800976

Facility Contacts

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Mustafa Kemal SAHIN, Dr

Role: primary

+905075800976

Eda Caferoglu, Dr

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 40197883 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 30734824 (View on PubMed)

Other Identifiers

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2025-05/79

Identifier Type: -

Identifier Source: org_study_id

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