Blood LossNCT01014728
Intraoperative Bleeding During Endoscopic Sinus Surgery
A study testing propofol and sevoflurane in people with Blood Loss, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Loss
- What is being tested?
- propofol and sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Blood Loss
- Being tested
- propofol, sevoflurane
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
100-200mcg/kg/min by infusion
sevofluraneDrug
1-3% of sevoflurane (expired)
| Study group | Role | What they receive |
|---|---|---|
| Intravenous anesthesia | Active comparator | Intravenous anesthesia with propofol for endoscopic sinus surgery Receives: Drug: propofol |
| Inhalation anesthesia | Active comparator | Inhalation anesthesia with sevoflurane for endoscopic sinus surgery Receives: Drug: sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from the start of surgery to the end of surgery, up to 6 hours
Secondary outcomes (2)
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).
Measured: at the end of surgery (up to 6 hours)
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.
Measured: at the end of surgery (up to 6 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Blood LossStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert M Naclerio, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014728
- Sponsor's protocol ID
- 09-317A
- Status last verified
- Jan 2014
- First submitted
- 13 Nov 2009
- Last updated
- 14 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01014728
- Acronym / sponsor ID
- 09-317A
- Conditions
- Blood Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 17 Nov 2009 (estimated)
- Results
- Posted 9 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous anesthesia | Active comparator | Drug: propofolIntravenous anesthesia with propofol for endoscopic sinus surgery |
| Inhalation anesthesia | Active comparator | Drug: sevofluraneInhalation anesthesia with sevoflurane for endoscopic sinus surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofol100-200mcg/kg/min by infusion | Drug | Intravenous anesthesia |
| sevoflurane1-3% of sevoflurane (expired) | Drug | Inhalation anesthesia |
Primary outcome
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.
2 secondary outcomes
Anesthesiologist Numeric Rating Scale (ANRS)
Time frame: at the end of surgery (up to 6 hours)
Surgeon's Numeric Rating Scale (SNRS)
Time frame: at the end of surgery (up to 6 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert M Naclerio, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propofol and sevoflurane in people with Blood Loss, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated Blood Loss (time frame: from the start of surgery to the end of surgery, up to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2014.