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Completed

NCT Number: NCT01014728

Intraoperative Bleeding During Endoscopic Sinus Surgery

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.

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Key information

Conditions

Blood Loss Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Chicago

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

100-200mcg/kg/min by infusion

Sevoflurane

Drug

1-3% of sevoflurane (expired)

Primary outcomes

  1. Estimated Blood Loss

    Time frame: from the start of surgery to the end of surgery, up to 6 hours

    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 outcomes

  1. Anesthesiologist Numeric Rating Scale (ANRS)

    Time frame: at the end of surgery (up to 6 hours)

    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).

  2. Surgeon's Numeric Rating Scale (SNRS)

    Time frame: at the end of surgery (up to 6 hours)

    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.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 17, 2009
Registry last updated
Feb 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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