Gastrointestinal CancerNCT07003061
Sarcopenia and Neuromuscular Block in Gastrointestinal Cancer Surgery
An observational study of Gastrointestinal Cancer and Sarcopenia, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate the effects of sarcopenia on intraoperative neuromuscular block (NMB) in patients undergoing gastrointestinal cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Cancer, Sarcopenia, Neuromuscular Blockade
- What is being tested?
- Standard Anesthesia Management
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 1 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea
Ankara, Yenimahalle, 06200
About this study
Official title: The Effects of Sarcopenia on Neuromuscular Block in Gastrointestinal Cancer Surgery
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.
Read the detailed description
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
- Gastrointestinal Cancer, Sarcopenia, Neuromuscular Blockade
- Being tested
- Standard Anesthesia Management
- Medical subject headings
- Gastrointestinal Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Anesthesia ManagementProcedure or surgery
All patients will receive standard anesthesia care as per institutional protocols. No experimental intervention will be applied.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Standard Anesthesia Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative (from induction until adequate block is achieved)
Depth of Neuromuscular Block (TOF Ratio)
Intraoperative depth of neuromuscular block, continuously monitored using TOF ratio.
Measured: 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).
Measured: 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.
Measured: Intraoperative (from administration of reversal agent to recovery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Jun 2025
- Primary completion10 Feb 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Kemal ŞAHİN, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Investigators
- Mustafa Kemal SAHIN, Principal investigator, Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and ReanimationMensure KAYA, Principal investigator, Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and ReanimationBelkis YILMAZ, Principal investigator, Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and ReanimationAhmet BAYRAK, Principal investigator, Ankara Oncology Education and Research Hospital Clinic of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003061
- Sponsor's protocol ID
- 2025-05/79
- Status last verified
- Apr 2026
- First submitted
- 26 May 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data (IPD) will be made available upon reasonable request after publication of the study results.
Publications
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.
PubMed 40197883Clark BC. Neuromuscular Changes with Aging and Sarcopenia. J Frailty Aging. 2019;8(1):7-9. doi: 10.14283/jfa.2018.35.
PubMed 30734824
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sarcopenia on Neuromuscular Block in Gastrointestinal Cancer Surgery
- ClinicalTrials.gov ID
- NCT07003061
- Acronym / sponsor ID
- 2025-05/79
- Conditions
- Gastrointestinal Cancer, Sarcopenia, Neuromuscular Blockade
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarcopenic | – | Procedure: Standard Anesthesia ManagementPatients 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. |
| Non-Sarcopenic | – | Procedure: Standard Anesthesia ManagementPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Anesthesia ManagementAll patients will receive standard anesthesia care as per institutional protocols. No experimental intervention will be applied. | Procedure or surgery | Non-Sarcopenic, Sarcopenic |
Primary outcome
Onset Time of Neuromuscular Block
Time frame: Intraoperative (from induction until adequate block is achieved)
Time from administration of the muscle relaxant to achievement of adequate neuromuscular block, measured by Train-of-Four (TOF) monitoring.
Depth of Neuromuscular Block (TOF Ratio)
Time frame: Intraoperative (from induction to end of surgery)
Intraoperative depth of neuromuscular block, continuously monitored using TOF ratio.
Duration of Neuromuscular Block
Time frame: Intraoperative (from muscle relaxant administration to recovery)
Time from administration of the muscle relaxant to recovery of neuromuscular function (TOF ratio ≥ 0.9).
Dose and Duration of Reversal Agent
Time frame: Intraoperative (from administration of reversal agent to recovery)
Total dose and time required for the reversal agent to achieve recovery from neuromuscular block.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 40197883Almeida 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.
- Background: PubMed 30734824Clark BC. Neuromuscular Changes with Aging and Sarcopenia. J Frailty Aging. 2019;8(1):7-9. doi: 10.14283/jfa.2018.35.
- Individual participant dataSharing planned: No. De-identified individual participant data (IPD) will be made available upon reasonable request after publication of the study results.
Related trials for Gastrointestinal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustafa Kemal SAHIN principal investigator
Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation
Mensure KAYA principal investigator
Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation
Belkis YILMAZ principal investigator
Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Cancer and Sarcopenia, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset Time of Neuromuscular Block (time frame: Intraoperative (from induction until adequate block is achieved)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07003061, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.