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

March 9, 2016 updated by: Ozlem Ozmete, Baskent University

Sugammadex Given for the Reversal of Deep Rocuronium Induced Neuromuscular Blockade Under Sevoflurane Anesthesia in Infants: A Retrospective Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sugammadex, Bridion
Drug were given intravenously by a anesthesiologist at the end of surgery
Drug: Sugammadex
Other Names:
  • Bridion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The efficacy of sugammadex were assessed by using Train of four (TOF)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

February 25, 2016

First Submitted That Met QC Criteria

March 9, 2016

First Posted (Estimate)

March 15, 2016

Study Record Updates

Last Update Posted (Estimate)

March 15, 2016

Last Update Submitted That Met QC Criteria

March 9, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA 16-67

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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