The Effect of Deep Neuromuscular Block on the Perioperative Stress Response Reduction and Postoperative Recovery Enhancement in Robot-assisted Stomach Cancer Surgery

Study Overview
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Brief Summary
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Stress reactions caused by surgical stimuli can cause sympathetic nervous system activation and increased stress hormones, such as catecholamines, inflammatory cytokines, and pituitary hormones, and insulin resistance. In addition, increased catecholamine levels may exacerbate postoperative outcomes, especially delayed wound recovery, increased cardiovascular and respiratory complications, and immunosuppression. In particular, it is important to reduce the stress response for cancer patients during surgery because they are already immunocompromised status and more vulnerable to perioperative stressful situation. However, there are insufficient results on the benefits of deep neuromuscular block in these patients, although some have reported a reduction of postoperative pain and fewer complications in the deep neuromuscular block compared with moderate neuromuscular block. Therefore, the investigators aim to investigate the difference in the stress response of patients who received conventional moderate neuromuscular block or deep neuromuscular block in robot-assisted gastric cancer surgery.

Official Title
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The Effect of Deep Neuromuscular Block on the Perioperative Stress Response Reduction and Postoperative Recovery Enhancement in Robot-assisted Stomach Cancer Surgery

Conditions
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Stomach Cancer

Intervention / Treatment
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* Drug: Deep neuromuscular block with 'rocunium®'
* Drug: Moderate neuromuscular block with 'rocunium®'


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. ASA Ⅰ - Ⅱ patients between 20 and 65 years undergoing robot-assisted gastric cancer surgery Exclusion Criteria: 1. Patients with neuromuscular disease 2. Hypertensive patients with β-blockers 3. Diabetic patients receiving insulin therapy 4. Patients with severe heart (EF <45%), kidney (GFR <60), liver dysfunction (ALT / AST> 100) 5. Patients with obesity (BMI ≥30) 6. Do not understand Korean language 7. For vulnerable subjects who are unable to obtain consent

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep neuromuscular block group<br> | Drug: Deep neuromuscular block with 'rocunium®'<br>* Rocuronium will be maintained in a arm 1) deep neuromuscular block group or arm 2) moderate neuromuscular block group (control group) according to the assignment. The degree of muscle relaxation is determined by 1 to 2 for post-tetanic count (PTC) in deep neuromuscular group.<br>|
| Experimental: Moderate neuromuscular block group<br> | Drug: Moderate neuromuscular block with 'rocunium®'<br>* Rocuronium will be maintained in a arm 1) deep neuromuscular block group or arm 2) moderate neuromuscular block group (control group) according to the assignment. The degree of muscle relaxation is determined by 1 to 2 for train-of-four (TOF) in moderate neuromuscular group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of stress responses between deep block and moderate block | Comparison of perioperative stress responses with biomarkers including cortisol, interleukin-6, natural killer cell and HRV between deep neuromuscular block group and moderate neuromuscular group | at baseline (T1) | 
| Difference of stress responses between deep block and moderate block | Comparison of perioperative stress responses with biomarkers including cortisol, interleukin-6, natural killer cell and HRV between deep neuromuscular block group and moderate neuromuscular group | 90 min after CO2 inflation (T2) | 
| Difference of stress responses between deep block and moderate block | Comparison of perioperative stress responses with biomarkers including cortisol, interleukin-6, natural killer cell and HRV between deep neuromuscular block group and moderate neuromuscular group | at the end of pneumoperitoneum (about 3 hours after CO2 inflation) (T3) | 
| Difference of stress responses between deep block and moderate block | Comparison of perioperative stress responses with biomarkers including cortisol, interleukin-6, natural killer cell and HRV between deep neuromuscular block group and moderate neuromuscular group | 1 day after surgery (T4) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deep neuromuscular block, robot-assisted surgery, stress response, stomach cancer