Sugammadex Versus Neostigmine Use in Patients Undergoing Septoplasty Operations

Nasal Septum Deviation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026999
• Other study ID #: 17393
• Status: Completed
• Phase: N/A
• First received: December 22, 2013
• Last updated: January 1, 2014
• Start date: January 2012
• Est. completion date: February 2013

Study information

• Verified date: January 2014
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics CommitteeTurkey: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• patient refusal

• any allergy to any medication used

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Nasal Septum Deviation
• Nose Deformities, Acquired

Locations

Country	Name	City	State
Turkey	Ankara University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	easy mask ventilation for septoplasty patients		time between end of surgery and extubation of the patient, approximately 5 to 10 minutes	Yes
Secondary	Quick and safe transfer from postoperative care unit		time spent in postanesthesia care unit approximately 10 to 60 minutes	Yes