Sugammadex Versus Neostigmine Use in Patients Undergoing Septoplasty Operations

January 1, 2014 updated by: CIGDEM YILDIRIM GUCLU, Ankara University

Phase IV Study of the Use of Sugammadex Versus Neostigmine in Septoplasty Operations

The purpose of this study to determine the effectiveness of sugammadex in septoplasty patients whose mask ventilation would be difficult after extubation.

Study Overview

Status

Completed

Conditions

Detailed Description

Patients undergoing septoplasty operation will be included to this study. After coming to operation room all the patients will have standard monitorisation and induction. After intubation they will have inhalational anesthesia as maintenance. According to the TOF (train of four) measurement all patient will have neuromuscular relaxant if needed. After the operation they will be extubated according to TOF or clinical parameters. And time for extubation, mask assistance need, any complication, mask difficulty, and time spent in postoperative care unit will be recorded. Then the results will be compared, whether sugammadex or neostigmine is better for these patients in means of extubation and postoperative status.

Study Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06550
        • Ankara University

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients undergoing septoplasty operation

Description

Inclusion Criteria:

ASA (American Society of Anesthesiologist) I-II patients undergoing septoplasty operation

Exclusion Criteria:

  • patient refusal
  • any allergy to any medication used

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
easy mask ventilation for septoplasty patients
Time Frame: time between end of surgery and extubation of the patient, approximately 5 to 10 minutes
time between end of surgery and extubation of the patient, approximately 5 to 10 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Quick and safe transfer from postoperative care unit
Time Frame: time spent in postanesthesia care unit approximately 10 to 60 minutes
time spent in postanesthesia care unit approximately 10 to 60 minutes

Collaborators and Investigators

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

Sponsor

Ankara University

Investigators

  • Principal Investigator: CIGDEM YILDIRIM GUCLU, MD, Ankara University Faculty of Medicine

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, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

December 22, 2013

First Submitted That Met QC Criteria

January 1, 2014

First Posted (Estimate)

January 3, 2014

Study Record Updates

Last Update Posted (Estimate)

January 3, 2014

Last Update Submitted That Met QC Criteria

January 1, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 17393 (Other Identifier: REB)

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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