Nasal Septum DeviationNCT02026999
Sugammadex Versus Neostigmine Use in Patients Undergoing Septoplasty Operations
An observational study of Nasal Septum Deviation, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study to determine the effectiveness of sugammadex in septoplasty patients whose mask ventilation would be difficult after extubation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasal Septum Deviation
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2012to Feb 2013
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing septoplasty operation
Who may be able to join
- ASA (American Society of Anesthesiologist) I-II patients undergoing septoplasty operation
Who cannot join
- patient refusal
- any allergy to any medication used
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Nasal Septum Deviation
What is being measured
The primary outcome is the main question the study is designed to answer.
easy mask ventilation for septoplasty patients
Measured: 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
Measured: time spent in postanesthesia care unit approximately 10 to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study startJan 2012
- Primary completionJan 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Septum DeviationStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CIGDEM YILDIRIM GUCLU, Ankara University
- Investigators
- CIGDEM YILDIRIM GUCLU, MD, Principal investigator, ANKARA UNIVERSITY FACULTY OF MEDICINE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026999
- Sponsor's protocol ID
- 17393
- Status last verified
- Jan 2014
- First submitted
- 22 Dec 2013
- Last updated
- 3 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of the Use of Sugammadex Versus Neostigmine in Septoplasty Operations
- ClinicalTrials.gov ID
- NCT02026999
- Acronym / sponsor ID
- 17393
- Conditions
- Nasal Septum Deviation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 3 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study to determine the effectiveness of sugammadex in septoplasty patients whose mask ventilation would be difficult after extubation.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing septoplasty operation
Key inclusion criteria (1 listed)
- ASA (American Society of Anesthesiologist) I-II patients undergoing septoplasty operation
Key exclusion criteria (2 listed)
- patient refusal
- any allergy to any medication used
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
easy mask ventilation for septoplasty patients
Time frame: time between end of surgery and extubation of the patient, approximately 5 to 10 minutes
1 secondary outcome
Quick and safe transfer from postoperative care unit
Time frame: time spent in postanesthesia care unit approximately 10 to 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2014.
Related trials for Nasal Septum Deviation
Not yet recruitingObservational study
Clinicoradiological Correlation Between Long Standing Untreated Adenoids and Nasal Septum Deviation in Adolescents
Nasal Septum Deviation
Recruiting
Comparative Study - Transseptal Suture Technique Verses Anterior Nasal Packing After Septoplasty
Deviated Nasal Septum, Postoperative Nasal Pain
Not yet recruiting
Evaluation of the Outcome of Septoplasty With or Without Inferior Turbinate Reduction
Deviated Nasal Septum, Nasal Obstruction Septal Deviation Compensatory Inferior Turbinate Hypertrophy
Not yet recruitingObservational study
Effect of Controlled Hypotension on GFAP and Cognition in Rhinoplasty
Nasal Septum Deviation, Rhinoplasty
Active, not recruitingObservational study
Comparison of Laryngeal Mask and Tracheal Intubation With and Without Topical Lidocaine Application
Comparison of Airway Management Techniques in Functional Endoscopic Sinus Surgery, Rhinosinusitis With Polyps
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CIGDEM YILDIRIM GUCLU, MD principal investigator
ANKARA UNIVERSITY FACULTY OF MEDICINE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Septum Deviation, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
easy mask ventilation for septoplasty patients (time frame: time between end of surgery and extubation of the patient, approximately 5 to 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2014.