NCT02026999

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 3, 2014

Completed
Last Updated

January 3, 2014

Status Verified

January 1, 2014

Enrollment Period

1 year

First QC Date

December 22, 2013

Last Update Submit

January 1, 2014

Conditions

Nasal Septum Deviation

Outcome Measures

Primary Outcomes (1)

  • easy mask ventilation for septoplasty patients

    time between end of surgery and extubation of the patient, approximately 5 to 10 minutes

Secondary Outcomes (1)

  • Quick and safe transfer from postoperative care unit

    time spent in postanesthesia care unit approximately 10 to 60 minutes

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing septoplasty operation

You may qualify if:

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

You may not qualify if:

  • patient refusal
  • any allergy to any medication used

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University

Ankara, 06550, Turkey (Türkiye)

Location

Study Officials

  • CIGDEM YILDIRIM GUCLU, MD

    ANKARA UNIVERSITY FACULTY OF MEDICINE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
anesthesiologist

Study Record Dates

First Submitted

December 22, 2013

First Posted

January 3, 2014

Study Start

January 1, 2012

Primary Completion

January 1, 2013

Study Completion

February 1, 2013

Last Updated

January 3, 2014

Record last verified: 2014-01

Locations

TU(1)