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

Colorectal Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02266056
• Other study ID #: 4-2014-0559
• Status: Completed
• Phase: N/A
• First received: August 26, 2014
• Last updated: October 16, 2015
• Start date: August 2014
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Drug:
• Deep neuromuscular block using rocuronium and reversal with suggamadex
Deep neuromuscular block and moderate neuromuscular block with Esmerone and reversal with bridion
• Moderate neuromuscular block using rocuronium and reversal with suggamadex
Moderate neuromuscular block and moderate neuromuscular block with Esmerone and reversal with bridion

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University, College of Medicine, Yonsei Health System, Yonsei Cancer Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No