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

Study Overview
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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.

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.

Official Title
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A Randomized, Parallel Design, Single-center Study to Compare of Surgical Condition and Postoperative Complications With Moderate and Deep Neuromuscular Blockade in Laparoscopic Gastrectomy

Conditions
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Neuromuscular Blockade

Intervention / Treatment
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* Drug: Rocuronium
* Drug: cis-atracurium


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Modarate Blockade Group<br>Neuromuscular blocking agent, cis-atracurium will be administered after skin incision and reversal agents, pyridostigmine & glycopyrrolate will be given for the recovery. | Drug: cis-atracurium<br>* Intermittent injection of cis-atracurium for TOF 1 + Pyridostigmine & Glycopyrrolate<br>* Other names: Nimbex®;|
| Experimental: Deep Blockade Group<br>Neuromuscular blocking agent, rocuronium will be administered after skin incision and reversal agent, Sugammadex will be given for the recovery. | Drug: Rocuronium<br>* Continuous infusion of rocuronium for PTC 1 + Sugammadex<br>* Other names: Esmeron®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical rating SCORE(SRS) | excellent (5), good but not optimal (4), moderate (3), poor but acceptable (2) or poor and unacceptable (1) | every 15 minutes from the pneumoperitoneum, up to 120 minutes till the end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory rate | Respiratory rate of patient | every 15 minutes from the arrival on the recovery room, up to 60 minutes | 
| peripheral arterial oxygen saturation | peripheral arterial oxygen saturation(sPO2) | every 15 minutes from the arrival on the recovery room, up to 60 minutes | 
| visual analogue scale (VAS) for pain | visual analogue scale (VAS) for pain | every 15 minutes from the arrival on the recovery room, up to 60 minutes | 
| occurrence of nausea or vomiting | occurrence of nausea or vomiting with Rhodes Index | every 15 minutes from the arrival on the recovery room, up to 60 minutes | 
| the level of sedation or alertness | the level of sedation or alertness with OAA/S scale | every 15 minutes from the arrival on the recovery room, up to 60 minutes | 
| Postoperative Quality Recovery Scale (PQRS) | physiologic, nociceptive, emotive, cognitive and activities of daily living | at baseline (the day before surgery), at 1 hour after surgery, at 6 hours after surgery, at 24 hours after surgery and at 7 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deep NM block, Surgeon's satisfaction, bridion