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

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 Overview

• Status: Completed
• Conditions: Stomach Cancer
• Intervention / Treatment: Drug: Deep neuromuscular block with 'rocunium®'; Drug: Moderate neuromuscular block with 'rocunium®'

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Deep neuromuscular block group	Drug: Deep neuromuscular block with 'rocunium®'; 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.
EXPERIMENTAL: Moderate neuromuscular block group	Drug: Moderate neuromuscular block with 'rocunium®'; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 3, 2019
• Primary Completion (ACTUAL): December 15, 2019
• Study Completion (ACTUAL): December 15, 2019

Study Registration Dates

• First Submitted: April 28, 2019
• First Submitted That Met QC Criteria: May 2, 2019
• First Posted (ACTUAL): May 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: stress response; robot-assisted surgery; stomach cancer; deep neuromuscular block
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 4-2019-0205

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No