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Sugammadex Given for the Reversal of Rocuronium Induced Neuromuscular Blockade Under Sevoflurane Anesthesia in Infants

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ClinicalTrials.gov Identifier: NCT02708056
Recruitment Status : Completed
First Posted : March 15, 2016
Last Update Posted : March 15, 2016
Sponsor:
Information provided by (Responsible Party):
Ozlem Ozmete, Baskent University

Brief Summary:
The objective of this study is to evaluate the efficacy and safety of sugammadex in reversing profound neuromuscular block induced by rocuronium in infant patients

Condition or disease Intervention/treatment Phase
Brain Cancer Drug: Sugammadex Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sugammadex Given for the Reversal of Deep Rocuronium Induced Neuromuscular Blockade Under Sevoflurane Anesthesia in Infants: A Retrospective Study
Study Start Date : January 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sugammadex, Bridion
Drug were given intravenously by a anesthesiologist at the end of surgery
Drug: Sugammadex
Other Name: Bridion




Primary Outcome Measures :
  1. The efficacy of sugammadex were assessed by using Train of four (TOF) [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between the ages of 1-12 month,
  • ASA physical status 1-3 who underwent elective brain cancer surgery during general anesthesia were included in the study

Exclusion Criteria:

  • younger than 1month or older than 12 months.
  • hepatic or renal failure
  • A history of allergy to study medication

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Responsible Party: Ozlem Ozmete, Medical Doctor, Baskent University
ClinicalTrials.gov Identifier: NCT02708056    
Other Study ID Numbers: KA 16-67
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: March 15, 2016
Last Verified: March 2016
Keywords provided by Ozlem Ozmete, Baskent University:
Sugammadex
Rocuronium
Infant patients
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sevoflurane
Rocuronium
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents