The Benefits of Deep Neuromuscular Block and Sugammadex in Laparoscopic Colorectal Surgery

Pneumoperitoneum, the use of carbon dioxide, presents some disadvantages, including a risk of hypercarbia and respiratory acidosis during surgery in the respiratory system, and of an increased mean arterial pressure and systemic vascular resistance due to sympathetic excitation in the cardiovascular system. 10~15 mmHg intra-abdominal pressure is required in order to achieve a pneumoperitoneum, and increased abdominal pressure following a pneumoperitoneum causes hemodynamic changes leading to a reduced cardiac function by increasing the left ventricular end systolic wall stress and the right and left ventricular filling pressure, while decreasing the stroke volume and cardiac index. The author compared the intra-abdominal pressure necessary to achieve a pneumoperitoneum under deep muscle relaxation and medium muscle relaxation in ten patients undergoing laparoscopic surgery for colorectal cancer as part of preliminary research. The results showed that deep muscle relaxation, compared to medium muscle relaxation, was able to lower the intra-abdominal pressure by an average of 5.6 mmHg (13.2 ± 0.8 vs 7.6 ± 1.1) and the inspiratory pressure by an average of 8. Above all, even after lowering the intra-abdominal pressure with deep muscle relaxation, the surgeon was able to maintain a view almost identical to the one afforded by medium muscle relaxation. However, up until now, no reports have clearly indicated the change in pneumoperitoneum pressure, the patient's hemodynamic change, post-operative recovery, and surgical prognosis depending on the depth of muscle relaxation.Against this background, this study aims to identify the degree to which intra-abdominal pressure in laparoscopic colorectal surgery can be reduced by deep muscle relaxation, and the corresponding advantages this method presents in terms of physiological changes such as hemodynamic and respiratory system changes. In addition, the study intends to examine the difference between deep muscle relaxation and medium muscle relaxation in terms of surgical prognosis, including their effects on post-operative pain and on the patient's recovery of intestinal mobility.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Deep neuromuscular block using rocuronium and reversal with suggamadex; Drug: Moderate neuromuscular block using rocuronium and reversal with suggamadex

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Yonsei University, College of Medicine, Yonsei Health System, Yonsei Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged 19 to 80 scheduled to undergo laparoscopic colorectal or rectal surgery below the ASA class 3

Exclusion Criteria:

• Patients with neuromuscular disease/patients with a personal history or family history of malignant hyperthermia/patients with a serious heart, kidney (GFR < 60) or liver condition (ALT/AST > 100)/ patients who have had colorectal or rectal surgery/obese patients (BMI ≥35)

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deep neuromuscular relaxation	Drug: Deep neuromuscular block using rocuronium and reversal with suggamadex; Deep neuromuscular block and moderate neuromuscular block with Esmerone and reversal with bridion
Active Comparator: Moderate neuromuscular relaxation	Drug: Moderate neuromuscular block using rocuronium and reversal with suggamadex; Moderate neuromuscular block and moderate neuromuscular block with Esmerone and reversal with bridion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intra-abdominal pressure	The difference of intra-abdominal pressure during peumoperitoneum between deep neuromuscular block and moderate neuromuscular block to identify the degree to which deep muscle relaxation can reduce intra-abdominal pressure while maintaining the surgeon's view in a laparoscopic colorectal surgery or laparoscopic rectal surgery, as well as examine the simultaneous hemodynamic changes and changes in the respiratory system.	5 minuits after pneumoperitoneum

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: August 26, 2014
• First Submitted That Met QC Criteria: October 10, 2014
• First Posted (Estimate): October 16, 2014

Study Record Updates

• Last Update Posted (Estimate): October 19, 2015
• Last Update Submitted That Met QC Criteria: October 16, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: sugammadex; deep neuromuscular block; laparoscopic colorectal surgery; hemodynamic change
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: 4-2014-0559