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

NCT03937440 | Completed DMC

• 1 other identifier: 4-2019-0205
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Stomach Cancer

Keywords

deep neuromuscular block; robot-assisted surgery; stress response; stomach cancer

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (2)

Deep neuromuscular block group

EXPERIMENTAL

Drug: Deep neuromuscular block with 'rocunium®'

Moderate neuromuscular block group

EXPERIMENTAL

Drug: Moderate neuromuscular block with 'rocunium®'

Interventions

Deep neuromuscular block with 'rocunium®' DRUG

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.

Deep neuromuscular block group

Moderate neuromuscular block with 'rocunium®' DRUG

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.

Moderate neuromuscular block group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. ASA Ⅰ - Ⅱ patients between 20 and 65 years undergoing robot-assisted gastric cancer surgery

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms; Fractures, Stress

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2019
• First Posted: May 3, 2019
• Study Start: July 3, 2019
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2019
• Last Updated: December 18, 2019

Record last verified: 2019-12

Locations

KR (1)