Intraoperative Bleeding During Endoscopic Sinus Surgery

This study is currently recruiting participants.

Verified September 2011 by University of Chicago

Sponsor:

Information provided by (Responsible Party):

Robert Naclerio, University of Chicago

ClinicalTrials.gov Identifier:

NCT01014728

First received: November 13, 2009

Last updated: September 12, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 13, 2009

Last Updated Date

September 12, 2011

Start Date ^ICMJE

November 2009

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

estimated blood loss [ Time Frame: 60 minutes after start of surgery ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01014728 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

platelet function assay (PFA)-100 [ Time Frame: at start of surgery and 60 minutes after start ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Intraoperative Bleeding During Endoscopic Sinus Surgery

Official Title ^ICMJE

Comparison of Intraoperative Bleeding During Endoscopic Sinus Surgery Between Patients Receiving Total Intravenous Anesthesia With Propofol and Patients Receiving an Inhalational Anesthetic With Sevoflurane

Brief Summary

The purpose of this study is to compare the blood loss during sinus surgery looking at two different types of anesthesia: either intravenous anesthesia with propofol or inhalational anesthesia with sevoflurane.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

patients undergoing endoscopic sinus surgery

Condition ^ICMJE

Blood Loss

Intervention ^ICMJE

Drug: propofol
100-200mcg/kg/min by infusion
Drug: sevoflurane
1-3% of sevoflurane (expired)

Study Group/Cohort (s)

Intravenous anesthesia
Intravenous anesthesia with propofol for endoscopic sinus surgery

Intervention: Drug: propofol
Inhalation anesthesia
Inhalation anesthesia with sevoflurane for endoscopic sinus surgery

Intervention: Drug: sevoflurane

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2012

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

male or female patients who are 18 years of age or older,
ASA grade 1 (normal otherwise healthy patient),
ASA grade 2 (patient with mild systemic disease),
patients who have chronic sinusitis with or without nasal polyps.

Exclusion Criteria:

pregnancy,
abnormal coagulation panel
preoperative use of NSAIDS or ASA medications within 7 days,
end-stage renal disease,
allergy to any of the used medications,
maximal body mass index over 35

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01014728

Other Study ID Numbers ^ICMJE

09-317A

Has Data Monitoring Committee

Responsible Party

Robert Naclerio, University of Chicago

Study Sponsor ^ICMJE

University of Chicago

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Robert M Naclerio, MD

University of Chicago

Information Provided By

University of Chicago

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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