The Effect of Deep Neuromuscular Block on the Perioperative Stress Response Reduction and Postoperative Recovery Enhancement in Robot-assisted Stomach Cancer Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yonsei University
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Difference of stress responses between deep block and moderate block
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ASA Ⅰ - Ⅱ patients between 20 and 65 years undergoing robot-assisted gastric cancer surgery
Exclusion Criteria
- •Patients with neuromuscular disease
- •Hypertensive patients with β-blockers
- •Diabetic patients receiving insulin therapy
- •Patients with severe heart (EF <45%), kidney (GFR <60), liver dysfunction (ALT / AST> 100)
- •Patients with obesity (BMI ≥30)
- •Do not understand Korean language
- •For vulnerable subjects who are unable to obtain consent
Arms & Interventions
Deep neuromuscular block group
Intervention: Deep neuromuscular block with 'rocunium®' (Drug)
Moderate neuromuscular block group
Intervention: Moderate neuromuscular block with 'rocunium®' (Drug)
Outcomes
Primary Outcomes
Difference of stress responses between deep block and moderate block
Time Frame: 1 day after surgery (T4)
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
Secondary Outcomes
No secondary outcomes reported