Clinical trial NCT03937440: The Effect of Deep Neuromuscular Block on the Perioperative Stress Response Reduction and Postoperative Recovery Enhancement in Robot-assisted Stomach Cancer Surgery
Official title: The Effect of Deep Neuromuscular Block on the Perioperative Stress Response Reduction and Postoperative Recovery Enhancement in Robot-assisted Stomach Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stomach Cancer
Keywords: deep neuromuscular block
robot-assisted surgery
stress response
stomach cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-05-03
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference of stress responses between deep block and moderate block
timeFrame: at baseline (T1)
measure: Difference of stress responses between deep block and moderate block
timeFrame: 90 min after CO2 inflation (T2)
measure: Difference of stress responses between deep block and moderate block
timeFrame: at the end of pneumoperitoneum (about 3 hours after CO2 inflation) (T3)
measure: Difference of stress responses between deep block and moderate block
timeFrame: 1 day after surgery (T4)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References: