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Intraoperative Bleeding During Endoscopic Sinus Surgery

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ClinicalTrials.gov Identifier: NCT01014728
Recruitment Status : Completed
First Posted : November 17, 2009
Results First Posted : January 9, 2014
Last Update Posted : February 14, 2014
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Blood Loss
Interventions Drug: propofol
Drug: sevoflurane
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intravenous Anesthesia Inhalation Anesthesia
Hide Arm/Group Description After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery. After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
Period Title: Overall Study
Started 18 15
Completed 18 15
Not Completed 0 0
Arm/Group Title Intravenous Anesthesia Inhalation Anesthesia Total
Hide Arm/Group Description After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery. After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery. Total of all reporting groups
Overall Number of Baseline Participants 18 15 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 15 participants 33 participants
41.3  (16.9) 43.4  (16.6) 42.3  (16.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 15 participants 33 participants
Female
9
  50.0%
7
  46.7%
16
  48.5%
Male
9
  50.0%
8
  53.3%
17
  51.5%
1.Primary Outcome
Title Estimated Blood Loss
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Anesthesia Inhalation Anesthesia
Hide Arm/Group Description:
After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
Overall Number of Participants Analyzed 18 15
Mean (Standard Deviation)
Unit of Measure: mL/h
78.5  (59.4) 80.3  (70.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intravenous Anesthesia, Inhalation Anesthesia
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.937
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Anesthesiologist Numeric Rating Scale (ANRS)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
There were three patients in the inhalation anesthesia group with missing values.
Arm/Group Title Intravenous Anesthesia Inhalation Anesthesia
Hide Arm/Group Description:
After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
Overall Number of Participants Analyzed 18 12
Median (Full Range)
Unit of Measure: units on a scale
7.25
(2 to 10)
9
(8 to 10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intravenous Anesthesia, Inhalation Anesthesia
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Surgeon’s Numeric Rating Scale (SNRS)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
There were three patients in the inhalation anesthesia group with missing values.
Arm/Group Title Intravenous Anesthesia Inhalation Anesthesia
Hide Arm/Group Description:
After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
Overall Number of Participants Analyzed 18 12
Median (Full Range)
Unit of Measure: units on a scale
6
(5 to 9)
7.25
(4 to 10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intravenous Anesthesia, Inhalation Anesthesia
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.461
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intravenous Anesthesia Inhalation Anesthesia
Hide Arm/Group Description After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery. After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
All-Cause Mortality
Intravenous Anesthesia Inhalation Anesthesia
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intravenous Anesthesia Inhalation Anesthesia
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Intravenous Anesthesia Inhalation Anesthesia
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/15 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Robert Naclerio
Organization: University of Chicago
Phone: 773-702-0080
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01014728     History of Changes
Other Study ID Numbers: 09-317A
First Submitted: November 13, 2009
First Posted: November 17, 2009
Results First Submitted: November 20, 2013
Results First Posted: January 9, 2014
Last Update Posted: February 14, 2014