Effectiveness of Sugammadex in LMS Surgery
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|ClinicalTrials.gov Identifier: NCT02329964|
Recruitment Status : Unknown
Verified August 2015 by Seol Ju, Park, Korea University Anam Hospital.
Recruitment status was: Active, not recruiting
First Posted : January 1, 2015
Results First Posted : September 28, 2015
Last Update Posted : September 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Muscle Relaxation||Drug: Sugammadex Drug: Neostigmine||Phase 4|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Comparison of the Effectiveness of Rocuronium - Sugammadex With Succinylcholine-Cisatracurium-Neostigmine in Patients Undergoing Laser Microlaryngeal Surgery|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||September 2016|
Experimental: R-S group
Sugammadex 2mg/kg was injected to patients to R-S group, as reversal of neuromuscular blockade.
Other Name: Bridion
Active Comparator: S-C-N group
Neostigmine (pyridostigmine) 0.2 mg/kg mg was injected to patients to S-C-N group, as reversal of neuromuscular blockade.
Other Name: Pyridostigmine(Pyrinol)
- 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.
- 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
- 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
- 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.
- 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
- Time to First Spontaneous Breath [ Time Frame: from end of surgery to first spontaneous breaths ]time 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.
- 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.
- Anesthesia Time [ Time Frame: from the anesthesia start to end ]time from propofol injection to extubation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329964
|Principal Investigator:||Jangeun Cho, M.D.,Ph.D.||Anesthesia and pain medicine department, Korea University Anam Hospital|