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Intraoperative Bleeding During Endoscopic Sinus Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01014728
First received: November 13, 2009
Last updated: January 21, 2014
Last verified: January 2014
  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: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Estimated Blood Loss [ Time Frame: from the start of surgery to the end of surgery, up to 6 hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Anesthesiologist Numeric Rating Scale (ANRS) [ Time Frame: at the end of surgery (up to 6 hours) ] [ Designated as safety issue: No ]
    The anesthesiologist numeric rating scale is to rate the ease of the anesthesia technique ranging from 0 to 10 (10 is best, 0 is worst).

  • Surgeon's Numeric Rating Scale (SNRS) [ Time Frame: at the end of surgery (up to 6 hours) ] [ Designated as safety issue: No ]
    The surgeon's numeric rating scale(SNRS)is to rate the surgical conditions (mucosal bleeding and visibility) on a scale ranging from 0 to 10, with 0 defined as cadaveric conditions and 10 as severe bleeding requiring constant suction.


Enrollment: 33
Study Start Date: November 2009
Study Completion Date: June 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intravenous anesthesia
Intravenous anesthesia with propofol for endoscopic sinus surgery
Drug: propofol
100-200mcg/kg/min by infusion
Active Comparator: 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Robert M Naclerio, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01014728     History of Changes
Other Study ID Numbers: 09-317A
Study First Received: November 13, 2009
Results First Received: November 20, 2013
Last Updated: January 21, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014