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

Not Applicable

Completed

• Conditions: Stomach Cancer
• Interventions: Drug: Deep neuromuscular block with 'rocunium®'; Drug: Moderate neuromuscular block with 'rocunium®'

• Registration Number: NCT03937440
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-28
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-03
• Study Start: 2019-07-03
• Status Verified: 2019-12
• Primary Completion: 2019-12-15
• Study Completion: 2019-12-15
• Last Update Submitted: 2019-12-17
• Last Update Posted: 2019-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deep neuromuscular block group	Deep neuromuscular block with 'rocunium®'	-
Moderate neuromuscular block group	Moderate neuromuscular block with 'rocunium®'	-

Primary Outcome Measures

Name	Time	Method
Difference of stress responses between deep block and moderate block	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

Trial Locations

Locations (1)

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