Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

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

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. Identifier: NCT02708056
Recruitment Status : Completed
First Posted : March 15, 2016
Last Update Posted : March 15, 2016
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

Layout table for study information
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

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

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

Layout table for additonal information
Responsible Party: Ozlem Ozmete, Medical Doctor, Baskent University 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:
Infant patients
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
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