Intraoperative Bleeding During Endoscopic Sinus Surgery
Comparison of Intraoperative Bleeding During Endoscopic Sinus Surgery Between Patients Receiving Total Intravenous Anesthesia With Propofol and Patients Receiving an Inhalational Anesthetic With Sevoflurane
1 other identifier
interventional
33
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 13, 2009
CompletedFirst Posted
Study publicly available on registry
November 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
January 9, 2014
CompletedFebruary 14, 2014
January 1, 2014
2.3 years
November 13, 2009
November 20, 2013
January 21, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Estimated Blood Loss
Estimated blood loss in milliliters per hour is calculated by subtracting the volume of total irrigation used during the case from the total amount of fluid in the suction canister at the end of surgery and dividing by surgical time in hours.
from the start of surgery to the end of surgery, up to 6 hours
Secondary Outcomes (2)
Anesthesiologist Numeric Rating Scale (ANRS)
at the end of surgery (up to 6 hours)
Surgeon's Numeric Rating Scale (SNRS)
at the end of surgery (up to 6 hours)
Study Arms (2)
Intravenous anesthesia
ACTIVE COMPARATORIntravenous anesthesia with propofol for endoscopic sinus surgery
Inhalation anesthesia
ACTIVE COMPARATORInhalation anesthesia with sevoflurane for endoscopic sinus surgery
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Chicago
Chicago, Illinois, 60637, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Robert Naclerio
- Organization
- University of Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Robert M Naclerio, MD
University of Chicago
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2009
First Posted
November 17, 2009
Study Start
November 1, 2009
Primary Completion
March 1, 2012
Study Completion
June 1, 2012
Last Updated
February 14, 2014
Results First Posted
January 9, 2014
Record last verified: 2014-01