Clinical trial NCT02329964: Effectiveness of Sugammadex in LMS Surgery
Official title: Comparison of the Effectiveness of Rocuronium - Sugammadex With Succinylcholine-Cisatracurium-Neostigmine in Patients Undergoing Laser Microlaryngeal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Muscle Relaxation
Keywords: Rocuronium
Sugammadex
Succinylcholine
Cisatracurium
Neostigmine
acceleromyography (TOF-Watch®)
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2015-01-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recovery of T1 to 90%
timeFrame: 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
measure: Surgical Rating Score
timeFrame: during surgery
measure: Addition of Neuromuscular Blocking Agents
timeFrame: during surgery
measure: Recovery of T1 to 10%
timeFrame: from the end of surgery to time when the TOF ratio is 0.1, up to 30 minutes
Secondary outcomes:
measure: Time to Extubation
timeFrame: from the end of surgery to extubate a tracheal tube
measure: Time to First Spontaneous Breath
timeFrame: from end of surgery to first spontaneous breaths
measure: Time to Eye Opening
timeFrame: from end of surgery to opening of the eyes to verbal commands
Other outcomes:
measure: Length of Stay in te Operating Room
timeFrame: time from in to out of the operating room
measure: Anesthesia Time
timeFrame: from the anesthesia start to end
Locations:
Study officials:
affiliation: Anesthesia and pain medicine department, Korea University Anam Hospital
name: Jangeun Cho, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.