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CompletedNCT01014728Updated Feb 14, 2014Results posted

Intraoperative Bleeding During Endoscopic Sinus Surgery

An interventional study of propofol and sevoflurane in Blood Loss, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-14.

Sponsored by University of Chicago · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Blood Loss

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03

In context

Hemorrhage

3,011 studies on the registry are indexed under Hemorrhage; 466 are open to participants now.

This study's enrollment of 33 is below the median of 100 across 1,990 interventional studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

University of Chicago is the lead sponsor of 924 studies on the registry; 186 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 71 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Active comparator
    Intravenous anesthesia

    Intravenous anesthesia with propofol for endoscopic sinus surgery

    Drug: propofol

  • Active comparator
    Inhalation anesthesia

    Inhalation anesthesia with sevoflurane for endoscopic sinus surgery

    Drug: sevoflurane

Interventions

06

What researchers measure

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.

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

Secondary outcomes

  1. Anesthesiologist Numeric Rating Scale (ANRS)

    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).

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

  2. Surgeon's Numeric Rating Scale (SNRS)

    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.

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

07

Results

Posted Jan 9, 2014

Participant flow

Participant flow — Overall Study
MilestoneIntravenous AnesthesiaInhalation Anesthesia
Started1815
Completed1815
Not completed00

Outcome measures

PrimaryEstimated 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.

Time frame:
from the start of surgery to the end of surgery, up to 6 hours
Reported as:
Mean · mL/h
Estimated Blood Loss
mL/hIntravenous AnesthesiaInhalation Anesthesia
Estimated Blood Loss78.5 ± 59.480.3 ± 70.2
Statistical analysis
  • Intravenous Anesthesia vs Inhalation Anesthesia · t-test, 2 sided · p = 0.937
SecondaryAnesthesiologist Numeric Rating Scale (ANRS)

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).

Time frame:
at the end of surgery (up to 6 hours)
Reported as:
Median · units on a scale
Anesthesiologist Numeric Rating Scale (ANRS)
units on a scaleIntravenous AnesthesiaInhalation Anesthesia
Anesthesiologist Numeric Rating Scale (ANRS)7.25 (2 to 10)9 (8 to 10)
Statistical analysis
  • Intravenous Anesthesia vs Inhalation Anesthesia · Wilcoxon (Mann-Whitney) · p = 0.002
SecondarySurgeon's Numeric Rating Scale (SNRS)

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.

Time frame:
at the end of surgery (up to 6 hours)
Reported as:
Median · units on a scale
Surgeon's Numeric Rating Scale (SNRS)
units on a scaleIntravenous AnesthesiaInhalation Anesthesia
Surgeon's Numeric Rating Scale (SNRS)6 (5 to 9)7.25 (4 to 10)
Statistical analysis
  • Intravenous Anesthesia vs Inhalation Anesthesia · Wilcoxon (Mann-Whitney) · p = 0.461

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intravenous Anesthesia—0/18 (0%)0/18 (0%)
Inhalation Anesthesia—0/15 (0%)0/15 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Intravenous AnesthesiaInhalation AnesthesiaTotal
Mean41.3 ± 16.943.4 ± 16.642.3 ± 16.5
Sex: Female, Male
Sex: Female, Male(Participants)Intravenous AnesthesiaInhalation AnesthesiaTotal
Female9716
Male9817
08

Study locations

1 site
  • The University of Chicago
    Chicago, Illinois 60637, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01014728
Responsible party
Sponsor
First posted
Nov 17, 2009
Start date
Nov 2009
Primary completion
Mar 2012
Completion
Jun 2012
Results posted
Jan 9, 2014
Last update
Feb 14, 2014

Study contacts

Robert M Naclerio, MD
principal investigator · University of Chicago

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Propofol · Sevoflurane

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