Trial Outcomes & Findings for Intraoperative Bleeding During Endoscopic Sinus Surgery (NCT NCT01014728)
NCT ID: NCT01014728
Last Updated: 2014-02-14
Results Overview
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.
COMPLETED
NA
33 participants
from the start of surgery to the end of surgery, up to 6 hours
2014-02-14
Participant Flow
Participant milestones
| Measure |
Intravenous Anesthesia
After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
|
Inhalation Anesthesia
After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
15
|
|
Overall Study
COMPLETED
|
18
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intraoperative Bleeding During Endoscopic Sinus Surgery
Baseline characteristics by cohort
| Measure |
Intravenous Anesthesia
n=18 Participants
After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
|
Inhalation Anesthesia
n=15 Participants
After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 16.9 • n=99 Participants
|
43.4 years
STANDARD_DEVIATION 16.6 • n=107 Participants
|
42.3 years
STANDARD_DEVIATION 16.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: from the start of surgery to the end of surgery, up to 6 hoursEstimated 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.
Outcome measures
| Measure |
Intravenous Anesthesia
n=18 Participants
After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
|
Inhalation Anesthesia
n=15 Participants
After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
|
|---|---|---|
|
Estimated Blood Loss
|
78.5 mL/h
Standard Deviation 59.4
|
80.3 mL/h
Standard Deviation 70.2
|
SECONDARY outcome
Timeframe: at the end of surgery (up to 6 hours)Population: There were three patients in the inhalation anesthesia group with missing values.
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).
Outcome measures
| Measure |
Intravenous Anesthesia
n=18 Participants
After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
|
Inhalation Anesthesia
n=12 Participants
After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
|
|---|---|---|
|
Anesthesiologist Numeric Rating Scale (ANRS)
|
7.25 units on a scale
Interval 2.0 to 10.0
|
9 units on a scale
Interval 8.0 to 10.0
|
SECONDARY outcome
Timeframe: at the end of surgery (up to 6 hours)Population: There were three patients in the inhalation anesthesia group with missing values.
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.
Outcome measures
| Measure |
Intravenous Anesthesia
n=18 Participants
After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
|
Inhalation Anesthesia
n=12 Participants
After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
|
|---|---|---|
|
Surgeon's Numeric Rating Scale (SNRS)
|
6 units on a scale
Interval 5.0 to 9.0
|
7.25 units on a scale
Interval 4.0 to 10.0
|
Adverse Events
Intravenous Anesthesia
Inhalation Anesthesia
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place