Compare of Surgical Condition and Complications With Moderate and Deep NM Block (MISPCNUHH)

Chonnam National University

Status: Unknown

Conditions: Neuromuscular Blockade

Treatments: Drug: Rocuronium; Drug: cis-atracurium

Study type: Interventional

Funder types: Other

Identifiers

NCT02601508

CNUHH-2015-135

Details and patient eligibility

About

This study is designed to evaluate the surgeon's satisfaction with either deep or moderate neuromuscular blockade during laparoscopic gastrectomy surgery and observe the recovery profiles in the recovery room and the ward.The explorative objective of this study is to evaluate the safety profiles of deep and moderate neuromuscular blockades via observation of postoperative complications.

Full description

Neuromuscular blocking agents (NMBAs) are frequently using during anesthesia to facilitate tracheal intubation and to improve surgical conditions. In an adequately anesthetized and monitored patient, the presence of one or two responses in the train-of-four (TOF) pattern normally indicates sufficient relaxation for most surgical procedures in general practices. It has been called moderate neuromuscular blockade (mNMB) condition. Nowadays, laparoscopic surgeries have expanded impressively into various areas of surgeries, both in scope and volume. If any hypothetical advantages of deep neuromuscular blockade (dNMB) during laparoscopic surgery turned out to be realized in practice with sufficient supporting evidence, it would become an important anesthetic option for better patient outcomes.

Enrollment: 80 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All adult (≥ 20 years of age) patients scheduled for an elective laparoscopic gastrectomy who have signed the written informed consent.

Exclusion criteria

• Known allergy to rocuronuim, cisatracurium or sugammadex
• Significant liver or kidney dysfunction
• Any neuromuscular disease
• Pregnant or breast feeding
• Indication for rapid sequence induction
• Inability to give informed consent
• Patients taking any medication with potential interference with neuromuscular transmission

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Modarate Blockade Group

Active Comparator group

Description:

Neuromuscular blocking agent, cis-atracurium will be administered after skin incision and reversal agents, pyridostigmine \& glycopyrrolate will be given for the recovery.

Treatment:

Drug: cis-atracurium

Deep Blockade Group

Experimental group

Description:

Neuromuscular blocking agent, rocuronium will be administered after skin incision and reversal agent, Sugammadex will be given for the recovery.

Treatment:

Drug: Rocuronium