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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-S group | Experimental | Rocuronium-Sugammadex group
|
|
| S-C-N group | Active Comparator | Succinylcholine-Cisatracurium-Neostigmine group
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | Sugammadex 2mg/kg was injected to patients to R-S group, as reversal of neuromuscular blockade. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay in te Operating Room | LMS surgery has short operation time and ambulatory setting. So the length of stay in the operating room will have significant. We expected the lengh of stay in the operating room is more shorter in R-S group than S-C-N group. | time from in to out of the operating room |
| Anesthesia Time |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jangeun Cho, M.D.,Ph.D. | Anesthesia and pain medicine department, Korea University Anam Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19387176 | Result | Lee C, Jahr JS, Candiotti KA, Warriner B, Zornow MH, Naguib M. Reversal of profound neuromuscular block by sugammadex administered three minutes after rocuronium: a comparison with spontaneous recovery from succinylcholine. Anesthesiology. 2009 May;110(5):1020-5. doi: 10.1097/ALN.0b013e31819dabb0. |
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Recruitment period : 2015.2.10 - 2015.6.30 Location : Korea University Medical Center Anam Hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | R-S Group | Rocuronium-Sugammadex group
|
| FG001 | S-C-N Group | Succinylcholine-Cisatracurium-Neostigmine group
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | R-S Group | Rocuronium-Sugammadex group
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | seconds | 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 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | R-S Group | Rocuronium-Sugammadex group
|
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The surgical rating score was assessed on the basis of the degree of laryngx exposure. This was influenced not only by neuromuscular relaxation but also by anatomical factors.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Seolju Park | Korea University Anam Hospital | +82-10-6314-6013 | gursla2@naver.com |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D009388 | Neostigmine |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Neostigmine | Drug | Neostigmine (pyridostigmine) 0.2 mg/kg mg was injected to patients to S-C-N group, as reversal of neuromuscular blockade. |
|
|
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 |
time from propofol injection to extubation |
| from the anesthesia start to end |
| BG001 | S-C-N Group | Succinylcholine-Cisatracurium-Neostigmine group
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| S-C-N Group |
Succinylcholine-Cisatracurium-Neostigmine group
|
|
|
| Primary | 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 | Posted | Median | Inter-Quartile Range | score | during surgery |
|
|
|
| Primary | 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 | Posted | Number | participants | during surgery |
|
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | seconds | from the end of surgery to extubate a tracheal tube |
|
|
|
| Other Pre-specified | Length of Stay in te Operating Room | LMS surgery has short operation time and ambulatory setting. So the length of stay in the operating room will have significant. We expected the lengh of stay in the operating room is more shorter in R-S group than S-C-N group. | Posted | Mean | Standard Deviation | minutes | time from in to out of the operating room |
|
|
|
| Other Pre-specified | Anesthesia Time | time from propofol injection to extubation | Posted | Mean | Standard Deviation | minutes | from the anesthesia start to end |
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | seconds | from the end of surgery to time when the TOF ratio is 0.1, up to 30 minutes |
|
|
|
| Secondary | Time to First Spontaneous Breath | time from end of surgery to first spontaneous breaths | Posted | Median | Inter-Quartile Range | seconds | from end of surgery to first spontaneous breaths |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | seconds | from end of surgery to opening of the eyes to verbal commands |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | S-C-N Group | Succinylcholine-Cisatracurium-Neostigmine group
| 0 | 40 | 0 | 40 |
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| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |