Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sugammadex Provide Better Surgical Condition Compared With Neostigmine in Laryngeal Microsurgery.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02330172
Recruitment Status : Completed
First Posted : January 1, 2015
Results First Posted : April 17, 2017
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Brief Summary:
This study aims to make a comparison of surgical condition and recovery time between rocuronium 0.45 mg/kg and neostigmine group and rocuronium 0.9 mg/kg and sugammadex group.

Condition or disease Intervention/treatment Phase
Neuromuscular Blockade Other: Injection of neostigmine or sugammadex Not Applicable

Detailed Description:
This study aims to make a comparison of surgical condition and recovery time between moderate neuromuscular bloackade with reversal using neostigmine group and deep neuromuscular bloackade with reversal using sugammadex group.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Sugammadex With Neostigmine in Laryngeal Microsurgery.
Study Start Date : May 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: rocuronium 0.45 - neostigmine

when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.

When the end of operation, a injection of neostigmine or sugammadex will be administered.

Other: Injection of neostigmine or sugammadex

At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.

During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected.

Other Name: neostigmin or sugammadex

Active Comparator: rocuronium 0.9 - sugammadex

When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.

When the end of operation,, a injection of neostigmine or sugammadex be administered.

Other: Injection of neostigmine or sugammadex

At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.

During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected.

Other Name: neostigmin or sugammadex




Primary Outcome Measures :
  1. Laryngoscopic Score [ Time Frame: At the beginning of surgery, the surgeon rated the laryngoscopy condition ]

    Definitions for evaluation of Laryngoscopycondition.

    : Easy = jaw relaxed, no resistance to blade insertion, fair = jaw not fully relaxed, slight resistance to blade insertion, difficult = poor jaw relaxation, active resistance of the patient to laryngoscopy.

    Variables Excellent Good Poor



Secondary Outcome Measures :
  1. Recovery Time From Neuromuscular Blockade [ Time Frame: from the injection of neostigmine or sugammadex up to 30 minutes ]
    We measured recovery time ffrom the injection of neostigmine or sugammadex to TOF ratio 0.9



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologist Physical status classification 1 or 2 elective laryngeal microsurgery under general anesthesia

Exclusion Criteria:

  • BMI >25 or < 20 kg/m2 Patients taking intercurrent medication Glutamic Oxalacetate Transaminase or Glutamic Pyruvate Transaminase > 40 IU/L, Cr > 1.4 mg/dl

Information from the National Library of Medicine

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): NCT02330172


Locations
Layout table for location information
Korea, Republic of
Eunsu Choi
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Ah Young Oh Bungdang Seoul National University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02330172    
Other Study ID Numbers: B1312230009
First Posted: January 1, 2015    Key Record Dates
Results First Posted: April 17, 2017
Last Update Posted: April 17, 2017
Last Verified: July 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Neostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents