Effectiveness of Sugammadex in LMS Surgery

August 31, 2015 updated by: Seol Ju, Park, Korea University Anam Hospital

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

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.

Study Overview

Status

Unknown

Conditions

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

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

  1. Induction of anesthesia : 1% propofol 1.5-2.5 mg/kg with fentanyl 1.5 mcg/kg
  2. Muscle relaxant agent : Rocuronium 1mg/kg
  3. After endotracheal intubation : normal saline(0.025 ml/kg)
  4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery : Rocuronium 0.15mg/kg
  5. Relaxant agent reversal. at the the end of surgery : sugammadex 2mg/kg
Sugammadex 2mg/kg was injected to patients to R-S group, as reversal of neuromuscular blockade.
Other Names:
  • Bridion
Active Comparator: S-C-N group

Succinylcholine-Cisatracurium-Neostigmine group

  1. Induction of anesthesia :1% propofol 1.5-2.5 mg/kg with fentanyl 1.5 mcg/kg
  2. Muscle relaxant agent :Succinylcholine 1mg/kg
  3. After endotracheal intubation : Cisatracurium 0.08mg/kg
  4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery : Succinylcholine 10mg
  5. 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)
Neostigmine (pyridostigmine) 0.2 mg/kg mg was injected to patients to S-C-N group, as reversal of neuromuscular blockade.
Other Names:
  • Pyridostigmine(Pyrinol)

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jangeun Cho, M.D.,Ph.D., Anesthesia and pain medicine department, Korea University Anam Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

December 27, 2014

First Submitted That Met QC Criteria

December 30, 2014

First Posted (Estimate)

January 1, 2015

Study Record Updates

Last Update Posted (Estimate)

September 28, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

August 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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