Compare of Surgical Condition and Complications With Moderate and Deep NM Block

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neuromuscular Blockade

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Modarate Blockade Group

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

Group Type ACTIVE_COMPARATOR

cis-atracurium

Intervention Type DRUG

Intermittent injection of cis-atracurium for TOF 1 + Pyridostigmine \& Glycopyrrolate

Deep Blockade Group

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

Group Type EXPERIMENTAL

Rocuronium

Intervention Type DRUG

Continuous infusion of rocuronium for PTC 1 + Sugammadex

Interventions

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Rocuronium

Continuous infusion of rocuronium for PTC 1 + Sugammadex

Intervention Type DRUG

cis-atracurium

Intermittent injection of cis-atracurium for TOF 1 + Pyridostigmine \& Glycopyrrolate

Intervention Type DRUG

Other Intervention Names

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Esmeron® Nimbex®

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No