- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02329964
Effectiveness of Sugammadex in LMS Surgery
Comparison of the Effectiveness of Rocuronium - Sugammadex With Succinylcholine-Cisatracurium-Neostigmine in Patients Undergoing Laser Microlaryngeal Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: R-S group
Rocuronium-Sugammadex group
|
Sugammadex 2mg/kg was injected to patients to R-S group, as reversal of neuromuscular blockade.
Other Names:
|
Active Comparator: S-C-N group
Succinylcholine-Cisatracurium-Neostigmine group
|
Neostigmine (pyridostigmine) 0.2 mg/kg mg was injected to patients to S-C-N group, as reversal of neuromuscular blockade.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recovery of T1 to 90%
Time Frame: 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
|
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
Time Frame: during surgery
|
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
Time Frame: during surgery
|
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%
Time Frame: from the end of surgery to time when the TOF ratio is 0.1, up to 30 minutes
|
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
Time Frame: from the end of surgery to extubate a tracheal tube
|
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 Frame: from end of surgery to first spontaneous breaths
|
time from end of surgery to first spontaneous breaths
|
from end of surgery to first spontaneous breaths
|
Time to Eye Opening
Time Frame: from end of surgery to opening of the eyes to verbal commands
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of Stay in te Operating Room
Time Frame: time from in to out of the 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
Time Frame: from the anesthesia start to end
|
time from propofol injection to extubation
|
from the anesthesia start to end
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jangeun Cho, M.D.,Ph.D., Anesthesia and pain medicine department, Korea University Anam Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LMS-sugammadex study KoreaUH
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