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

NCT ID: NCT02266056

Last Updated: 2015-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-09-30

Brief Summary

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

Deep neuromuscular relaxation

Group Type: EXPERIMENTAL

Deep neuromuscular block using rocuronium and reversal with suggamadex

Intervention Type: DRUG

Deep neuromuscular block and moderate neuromuscular block with Esmerone and reversal with bridion

Moderate neuromuscular relaxation

Group Type: ACTIVE_COMPARATOR

Moderate neuromuscular block using rocuronium and reversal with suggamadex

Intervention Type: DRUG

Moderate neuromuscular block and moderate neuromuscular block with Esmerone and reversal with bridion

Interventions

Deep neuromuscular block using rocuronium and reversal with suggamadex

Deep neuromuscular block and moderate neuromuscular block with Esmerone and reversal with bridion

Intervention Type: DRUG

Moderate neuromuscular block using rocuronium and reversal with suggamadex

Moderate neuromuscular block and moderate neuromuscular block with Esmerone and reversal with bridion

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yonsei University, College of Medicine, Yonsei Health System, Yonsei Cancer Center

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

4-2014-0559

Identifier Type: -

Identifier Source: org_study_id