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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
  Purpose

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.


Condition Intervention
Blood Loss
 Drug: propofol
Drug: sevoflurane

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison of Intraoperative Bleeding During Endoscopic Sinus Surgery Between Patients Receiving Total Intravenous Anesthesia With Propofol and Patients Receiving an Inhalational Anesthetic With Sevoflurane

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by University of Chicago:

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

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

Estimated Enrollment: 40
Study Start Date: November 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Intravenous anesthesia
Intravenous anesthesia with propofol for endoscopic sinus surgery
 Drug: propofol
100-200mcg/kg/min by infusion
Inhalation anesthesia
Inhalation anesthesia with sevoflurane for endoscopic sinus surgery
 Drug: sevoflurane
1-3% of sevoflurane (expired)

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

patients undergoing endoscopic sinus surgery

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01014728

Locations
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Marcy deTineo, BSN, CCRC     773-702-5889     mdetineo@surgery.bsd.uchicago.edu    
Principal Investigator: Robert M Naclerio, MD            
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Robert M Naclerio, MD University of Chicago
  More Information

No publications provided

Responsible Party: Robert Naclerio, Professor, University of Chicago
ClinicalTrials.gov Identifier: NCT01014728     History of Changes
Other Study ID Numbers: 09-317A
Study First Received: November 13, 2009
Last Updated: September 12, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications
Anesthetics
Propofol
Sevoflurane
Anesthetics, Inhalation
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on May 16, 2013