Back to resultsSugammadex Given for the Reversal of Rocuronium Induced Neuromuscular Blockade Under Sevoflurane Anesthesia in Infants
Primary Purpose
Brain Cancer
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Sugammadex
Sponsored by
About this trial
This is an interventional treatment trial for Brain Cancer focused on measuring Sugammadex, Rocuronium, Infant patients
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Sugammadex, Bridion
Arm Description
Drug were given intravenously by a anesthesiologist at the end of surgery
Outcomes
Primary Outcome Measures
The efficacy of sugammadex were assessed by using Train of four (TOF)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02708056
Brief Title
Sugammadex Given for the Reversal of Rocuronium Induced Neuromuscular Blockade Under Sevoflurane Anesthesia in Infants
Official Title
Sugammadex Given for the Reversal of Deep Rocuronium Induced Neuromuscular Blockade Under Sevoflurane Anesthesia in Infants: A Retrospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Cancer
Keywords
Sugammadex, Rocuronium, Infant patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sugammadex, Bridion
Arm Type
Other
Arm Description
Drug were given intravenously by a anesthesiologist at the end of surgery
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Other Intervention Name(s)
Bridion
Primary Outcome Measure Information:
Title
The efficacy of sugammadex were assessed by using Train of four (TOF)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
Sugammadex Given for the Reversal of Rocuronium Induced Neuromuscular Blockade Under Sevoflurane Anesthesia in Infants
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