Effectiveness of Sugammadex in LMS Surgery

Study Overview
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Brief Summary
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This study is comparing of rocuronium-sugammadex and succinylcholine during LMS surgery that is characterized by short operation time, required intense paralysis and ambulatory setting, has not been investigated.

Detailed Description
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Laser microlaryngeal surgery (LMS) requires brief and intense paralysis in the short operation time and the ambulatory setting. The ideal muscle relaxant with rapid onset time, short duration of action and minimal side effects is not yet available. Succinylcholine (SCC) is commonly used muscle relaxant for LMS because of its rapid onset time and short duration of action. The use of SCC for tracheal intubation is usually followed by repeated small boluses or drip of SCC or small boluses of nondepolarizing muscle relaxants with intermediate duration. As an alternative to SCC, the non-depolarizing neuromuscular blocking agent rocuronium can be used for LMS. The onset of rocuronium 1mg/kg is around 60s that is similar to SCC. However higher doses of rocuronium have a long duration of action; this is inappropriate in ambulatory surgery that requires rapid recovery of neuromuscular function and rapid turnover. Sugammadex has recently been introduced as a selective relaxant-binding agent that allows for rapid reversal of rocuronium-induced neuromuscular blockade. Even profound neuromuscular block with rocuronium can be quickly antagonized with sugammadex. After obtaining Institutional Review Board approval and written informed consent, 80 patients is enrolling in this study. Patients is divided by two groups randomly as the Rocuronium-Sugammadex group(R-S group) and the Succinylcholine - Cisatracurium- Neostigmine group(S-C-N group) . Anesthesia was induced with intravenous propofol 1.5-2.5 mg/kg, together with fentanyl1.5 mcg/kg After induction of anesthesia, neuromuscular monitoring is performed continuously at the adductor pollicis muscle with acceleromyography (TOF-Watch®). Subsequently, in the R-S group, patients receive rocuronium 1mg/kg and in the S-C-N group, patients receive SCC 1mg/kg. After T1 assessed as being zero by neuromuscular monitoring, endotracheal intubation is performed. After endotracheal intubation, in the S-C-N group, cisatracurium 0.08mg/kg is injected and in the R-S group, the same volume of normal saline is injected. Anesthesia is maintained with desflurane with air during the surgery. Additive dose of rocuronium 0.15mg/kg or SCC 10mg is given as necessary to ensure that neuromuscular blockade remains below T2 during surgery. After the surgical procedure ends, patients receive sugammadex 2mg/kg in the R-S group, and pyridostigmine 0.2 mg/kg with atropine 10mcg/kg in the S-C-N group at the appearance of second TOF twitch (T2). Patient will be assessed for the time to recovery of the TOF ratio to 0.9, surgical rating scale (1- extremely poor conditions, 2- poor conditions, 3- acceptable conditions, 4- good conditions, 5- optimal conditions), and anesthesia time.

Official Title
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Comparison of the Effectiveness of Rocuronium - Sugammadex With Succinylcholine-Cisatracurium-Neostigmine in Patients Undergoing Laser Microlaryngeal Surgery

Conditions
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Muscle Relaxation

Intervention / Treatment
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* Drug: Sugammadex
* Drug: Neostigmine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologist[ASA] class 1-3 scheduled Laser microlaryngeal surgery under general anesthesia written informed consent Exclusion Criteria: suspected difficult tracheal intubation disorder affecting neuromuscular blockade known or suspected significant renal dysfunction known or suspected severe hepatic dysfunction history of malignant hyperthermia allergy of opioids, neuromuscular blocking drugs or other medications used during general anesthesia contraindication to pyridostigmine and/or atropine pregnancy breast feeding body mass index > 27kg/m2

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: R-S group<br>Rocuronium-Sugammadex group Induction of anesthesia : 1% propofol 1.5-2.5 mg/kg with fentanyl 1.5 mcg/kg Muscle relaxant agent : Rocuronium 1mg/kg After endotracheal intubation : normal saline(0.025 ml/kg) Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery : Rocuronium 0.15mg/kg Relaxant agent reversal. at the the end of surgery : sugammadex 2mg/kg | Drug: Sugammadex<br>* Sugammadex 2mg/kg was injected to patients to R-S group, as reversal of neuromuscular blockade.<br>* Other names: Bridion;|
| Active Comparator: S-C-N group<br>Succinylcholine-Cisatracurium-Neostigmine group Induction of anesthesia :1% propofol 1.5-2.5 mg/kg with fentanyl 1.5 mcg/kg Muscle relaxant agent :Succinylcholine 1mg/kg After endotracheal intubation : Cisatracurium 0.08mg/kg Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery : Succinylcholine 10mg Relaxant agent reversal at the appearance of second TOF twitch (T2) : Neostigmine 0.2mg/kg with atropine 10 mcg/kg (for preventing side effects of neostigmine) | Drug: Neostigmine<br>* Neostigmine (pyridostigmine) 0.2 mg/kg mg was injected to patients to S-C-N group, as reversal of neuromuscular blockade.<br>* Other names: Pyridostigmine(Pyrinol);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of T1 to 90% | we measure the time from the end of surgery to recovery of the TOF 0.9. The end of surgery is defined as the time when the direct laryngoscope, aided by an operation microscope, is removed. | from the end of surgery(when the surgeon removes the suspension laryngoscope ) to time when the TOF ratio is 0.9, up to 30 minutes | 
| Surgical Rating Score | describe by surgeon under his subjective opinion. 1 - extremely poor conditions 2- poor conditions 3- acceptable conditions 4- good conditions 5- optimal conditions | during surgery | 
| Addition of Neuromuscular Blocking Agents | Repeated small boluses or drip of Succinylcholine, or small boluses of nondepolarizing muscle relaxants with intermediate duration are usually followed. In this protocol, cisatracurium was injected after intubation to maintain neuromuscular blockade during surgery. We measure the requirement of additive dose of neuromuscular blocker to ensure that neuromuscular blockade remains below T2 during surgery | during surgery | 
| Recovery of T1 to 10% | we measure the time from the end of surgery to recovery of the TOF 0.1. The end of surgery is defined as the time when the direct laryngoscope, aided by an operation microscope, is removed. | from the end of surgery to time when the TOF ratio is 0.1, up to 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Extubation | We expected the emergence time is shorter in R-S group than S-C-N group. So we measure the time from the end of surgery to recovery of the TOF 0.9, and the time from the end of surgery to extubation | from the end of surgery to extubate a tracheal tube | 
| Time to First Spontaneous Breath | time from end of surgery to first spontaneous breaths | from end of surgery to first spontaneous breaths | 
| Time to Eye Opening | We expected the emergence time is shorter in R-S group than S-C-N group. So we measure the time from the end of surgery to opening of the eyes to verbal commands. | from end of surgery to opening of the eyes to verbal commands | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rocuronium, Sugammadex, Succinylcholine, Cisatracurium, Neostigmine, acceleromyography (TOF-Watch®)