Effects of Neuromuscular Blockade Level and Intra-abdominal Pressure on Surgical Conditions and Cardiopulmonary Responses During Laparoscopic Colon Surgery With the Trendelenburg Position

Seoul National University

Status: Completed

Conditions: Cardiac Index

Treatments: Drug: Deep neuromuscular blockade; Drug: Conventional neuromuscular blockade; Device: Standard abdominal pressure; Device: Low abdominal pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT02249585

1405-010-576

Details and patient eligibility

About

The purpose of this study is to find out the effect of low abdominal pressure vs. standard abdominal pressure on the cardiac and respiratory function of the patients undergoing laparoscopic colon surgery in Trendelenberg position. It was also designed to evaluate the effect of the degree of neuromuscular blockade on the surgical condition of the patients undergoing laparoscopic colon surgery in Trendelenberg position.

Enrollment: 131 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for laparoscopic colon surgery under Trendelenberg position

Exclusion criteria

• ASA classification IV
• Unable to make a written, informed consent
• Allergic to neuromuscular blocking agents, anesthetics, opioids
• Patients with neuromuscular disease
• Hepatic failure
• Renal failure
• History of malignant hyperthermia
• Morbid obesity with BMI>35 kg/m2
• Patients enrolled in another clinical trials

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

131 participants in 3 patient groups

CS

Experimental group

Description:

Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure.

Treatment:

Device: Standard abdominal pressure

Drug: Conventional neuromuscular blockade

DS

Experimental group

Description:

Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure.

Treatment:

Device: Standard abdominal pressure

Drug: Deep neuromuscular blockade

DL

Experimental group

Description:

Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.

Treatment:

Device: Low abdominal pressure

Drug: Deep neuromuscular blockade