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Intraocular Pressure Changes Associated With Tracheal Extubation: Comparison of Sugammadex With Conventional Reversal of Neuromuscular Blockade

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: NCT02215382
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
özgür yağan, T.C. ORDU ÜNİVERSİTESİ

Brief Summary:

The aim of this study, comparison of effects of sugammadex versus neostigmine/atropine combination on hemodynamic parameters and intraocular pressure during tracheal extubation.

This prospective, randomised study was designed to compare two reversal methods with respect to changes in IOP, heart rate and blood pressure during tracheal extubation period.


Condition or disease Intervention/treatment Phase
Intraocular Pressure Changes During Tracheal Extubation Drug: sugammadex Drug: neostigmine+atropine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Study Start Date : August 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: sugammadex Drug: sugammadex
sugammadex 2 mg/kg

Active Comparator: neostigmine + atropine Drug: neostigmine+atropine
neostigmine 0,05 mg/kg + atropine 0,025 mg/kg




Primary Outcome Measures :
  1. intraocular pressure [ Time Frame: baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation ]

Secondary Outcome Measures :
  1. heart rate [ Time Frame: baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation ]
  2. blood pressure [ Time Frame: baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-II physical status
  • elective surgery
  • endotracheal intubation under general anesthesia

Exclusion Criteria:

  • emergency surgery
  • pregnancy
  • laparoscopic surgery
  • prone position
  • BMI > 30 kg/m2
  • sedative drug use in last month
  • patients with glaucoma.
  • ASA > II physical status

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): NCT02215382


Locations
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Turkey
Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital
Altınordu, Ordu, Turkey, 52100
Sponsors and Collaborators
T.C. ORDU ÜNİVERSİTESİ

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Responsible Party: özgür yağan, MD, assistant professor, T.C. ORDU ÜNİVERSİTESİ
ClinicalTrials.gov Identifier: NCT02215382    
Other Study ID Numbers: Odu-3
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: August 2014
Keywords provided by özgür yağan, T.C. ORDU ÜNİVERSİTESİ:
two reversal methods
changes in IOP
heart rate
blood pressure
tracheal extubation
Additional relevant MeSH terms:
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Atropine
Neostigmine
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinesterase Inhibitors
Enzyme Inhibitors
Parasympathomimetics