Blood Loss
Conditions
Brief 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.
Interventions
DRUGpropofol
100-200mcg/kg/min by infusion
DRUGsevoflurane
1-3% of sevoflurane (expired)
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Blood Loss | 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
| Measure | Time frame | Description |
|---|---|---|
| Anesthesiologist Numeric Rating Scale (ANRS) | 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). |
| Surgeon's Numeric Rating Scale (SNRS) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intravenous Anesthesia After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery. | 18 |
| Inhalation Anesthesia After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery. | 15 |
| Total | 33 |
Baseline characteristics
| Characteristic | Intravenous Anesthesia | Inhalation Anesthesia | Total |
|---|---|---|---|
| Age, Continuous | 41.3 years STANDARD_DEVIATION 16.9 | 43.4 years STANDARD_DEVIATION 16.6 | 42.3 years STANDARD_DEVIATION 16.5 |
| Sex: Female, Male Female | 9 Participants | 7 Participants | 16 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 15 |
| serious Total, serious adverse events | 0 / 18 | 0 / 15 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Anesthesia | Estimated Blood Loss | 78.5 mL/h | Standard Deviation 59.4 |
| Inhalation Anesthesia | Estimated Blood Loss | 80.3 mL/h | Standard Deviation 70.2 |
p-value: 0.937t-test, 2 sided
Secondary
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)
Population: There were three patients in the inhalation anesthesia group with missing values.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Anesthesia | Anesthesiologist Numeric Rating Scale (ANRS) | 7.25 units on a scale |
| Inhalation Anesthesia | Anesthesiologist Numeric Rating Scale (ANRS) | 9 units on a scale |
p-value: 0.002Wilcoxon (Mann-Whitney)
Secondary
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)
Population: There were three patients in the inhalation anesthesia group with missing values.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Anesthesia | Surgeon's Numeric Rating Scale (SNRS) | 6 units on a scale |
| Inhalation Anesthesia | Surgeon's Numeric Rating Scale (SNRS) | 7.25 units on a scale |
p-value: 0.461Wilcoxon (Mann-Whitney)