Chronic Rhinosinusitis (Diagnosis)NCT03815435
The Influence of Blood Pressure Upon the Clarity of Surgical Field in Endonasal Surgery
A study of Chronic Rhinosinusitis (Diagnosis), run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
The work compares the effect of different various values of arterial blood pressure on the clarity of the surgical field in pansinusoperation in patients with chronic rhinosinusitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic rhinosinusitis undergoing pansinusoperation
- Age over 18 years
- Concrete surgeon (Petr Matoušek, MD, Ph.D., MBA)
- Concrete anaesthetist (Michal Parma, MD)
Who cannot join
- Coagulopathy
- Thrombocytopathies
- Vascular wall disorders
- Thrombophlebitis
- Anticoagulation or anti-aggregation therapy
- History of malignancy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
About this study
The work compares the effect of different various values of arterial blood pressure on the clarity of the surgical field in pansinusoperation in patients with chronic rhinosinusitis.
Read the detailed description
The work compares the effect of different values of arterial pressure on the clarity of the surgical field in pansinus operation in patients with chronic rhinosinusitis. A secondary goal of the study is to compare circulatory parameters, depth of anaesthesia, near-infrared spectroscopy (NIRS) and consumption of hypotensives.
Null hypothesis: There is no difference in the clarity of the surgical field at various levels of the mean arterial pressure.
This study is being realized in accordance with the Declaration of Helsinki and has been approved by the Ethics Committee of the University Hospital Ostrava (849/2018). According to the statement of the State Institute for Drug Control of 26th April 2019 (reference number Sukl96964/2019), the trial is not considered a clinical trial of medicinal products.
Study type: Single-blind study (the surgeon does not know the value of the patient's blood pressure) prospective study.
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Being tested
- Controlled hypotension
- Keywords
- Surgical field clarity, Endonasal surgery, Intraoperative bleeding
- Medical subject headings
- Disease, Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled hypotensionProcedure or surgery
Controlled hypotension will be administered according to the clarity of the surgical field.
| Study group | Role | What they receive |
|---|---|---|
| Controlled hypotension | Experimental | Controlled hypotension will be administered according to the clarity of the surgical field evaluated according to the Boezaart scale (1995). Receives: Procedure: Controlled hypotension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical field clarity in relation to the value of arterial pressure
Clarity of the surgical field will be assessed on a scale of 0-5, according to the Boezaart's system (1995)
Measured: 13 months
Secondary outcomes (14)
Blood pressure
Blood pressure will be measured in the morning before surgery, on arrival at the operating theatre and further 5 minutes after anaesthesia, and every five minutes during the surgery.
Measured: 13 months
Heart rate
Heart rate will be measured in the morning before surgery, on arrival at the operating theatre and further 5 minutes after anaesthesia, and every five minutes during the surgery.
Measured: 13 months
Depth of anaesthesia
Depth of anaesthesia will be measured using the BIS value every 5 minutes
Measured: 13 months
Near infrared spectroscopy (NIRS)
Cerebral perfusion will be measured using the NIRS value every 5 minutes
Measured: 13 months
Consumption of hypotensives
Consumption of hypotensives (Nitro Pohl) will be measured in mg/hr
Measured: 13 months
Blood loss
Blood loss (ml) during the surgery will be measured
Measured: 13 months
Recovery from anaesthesia duration
The interval from the end of surgery to eye opening in minutes will be measured.
Measured: 13 months
Postoperative pain
Postoperative pain will be measured using the VAS (Visual Analogue Scale) upon arrival to the recovery room and the standard ward.
Measured: 13 months
Cognitive function
The standardised clock-drawing test will be performed at the ward, 2 hours after surgery.
Measured: 13 months
Postoperative nausea
The presence of postoperative nausea (YES/NO) will be observed.
Measured: 13 months
Postoperative vomiting
The presence of postoperative vomiting (YES/NO) will be observed.
Measured: 13 months
Complications of controlled hypotension
The presence of complications of controlled hypotension (stroke, myocardial infarction, kidney injury - YES/NO) will be observed.
Measured: 13 months
Use of tamponade
The need to use tamponade due to bleeding (YES/NO) will be observed.
Measured: 13 months
Surgical revision
The need for surgical revision due to bleeding (YES/NO) will be observed.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start1 Jan 2019
- Primary completion31 Jan 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Rhinosinusitis (Diagnosis)Studies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- The study subjects will be enrolled into one arm.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ondřej Jor, MD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815435
- Sponsor's protocol ID
- KARIM-01-ENSURGERY
- Status last verified
- Mar 2023
- First submitted
- 21 Jan 2019
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Publications
Thongrong C, Kasemsiri P, Carrau RL, Bergese SD. Control of bleeding in endoscopic skull base surgery: current concepts to improve hemostasis. ISRN Surg. 2013 Jun 13;2013:191543. doi: 10.1155/2013/191543. Print 2013.
PubMed 23844295Kelly EA, Gollapudy S, Riess ML, Woehlck HJ, Loehrl TA, Poetker DM. Quality of surgical field during endoscopic sinus surgery: a systematic literature review of the effect of total intravenous compared to inhalational anesthesia. Int Forum Allergy Rhinol. 2013 Jun;3(6):474-81. doi: 10.1002/alr.21125. Epub 2012 Dec 19.
PubMed 23258603Athanasiadis T, Beule A, Embate J, Steinmeier E, Field J, Wormald PJ. Standardized video-endoscopy and surgical field grading scale for endoscopic sinus surgery: a multi-centre study. Laryngoscope. 2008 Feb;118(2):314-9. doi: 10.1097/MLG.0b013e318157f764.
PubMed 17989575Milonski J, Zielinska-Blizniewska H, Golusinski W, Urbaniak J, Sobanski R, Olszewski J. Effects of three different types of anaesthesia on perioperative bleeding control in functional endoscopic sinus surgery. Eur Arch Otorhinolaryngol. 2013 Jul;270(7):2045-50. doi: 10.1007/s00405-012-2311-1. Epub 2012 Dec 22.
PubMed 23263204
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Blood Pressure Upon the Clarity of Surgical Field in Endonasal Surgery
- ClinicalTrials.gov ID
- NCT03815435
- Acronym / sponsor ID
- KARIM-01-ENSURGERY
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Keywords
- Surgical field clarity, Endonasal surgery, Intraoperative bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The work compares the effect of different various values of arterial blood pressure on the clarity of the surgical field in pansinusoperation in patients with chronic rhinosinusitis.
Detailed description
The work compares the effect of different values of arterial pressure on the clarity of the surgical field in pansinus operation in patients with chronic rhinosinusitis. A secondary goal of the study is to compare circulatory parameters, depth of anaesthesia, near-infrared spectroscopy (NIRS) and consumption of hypotensives.
Null hypothesis: There is no difference in the clarity of the surgical field at various levels of the mean arterial pressure.
This study is being realized in accordance with the Declaration of Helsinki and has been approved by the Ethics Committee of the University Hospital Ostrava (849/2018). According to the statement of the State Institute for Drug Control of 26th April 2019 (reference number Sukl96964/2019), the trial is not considered a clinical trial of medicinal products.
Study type: Single-blind study (the surgeon does not know the value of the patient's blood pressure) prospective study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study subjects will be enrolled into one arm.
| Arm | Type | Receives |
|---|---|---|
| Controlled hypotension | Experimental | Procedure: Controlled hypotensionControlled hypotension will be administered according to the clarity of the surgical field evaluated according to the Boezaart scale (1995). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with chronic rhinosinusitis undergoing pansinusoperation
- Age over 18 years
- Concrete surgeon (Petr Matoušek, MD, Ph.D., MBA)
- Concrete anaesthetist (Michal Parma, MD)
Key exclusion criteria (7 listed)
- Coagulopathy
- Thrombocytopathies
- Vascular wall disorders
- Thrombophlebitis
- Anticoagulation or anti-aggregation therapy
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 |
|---|---|---|
| Controlled hypotensionControlled hypotension will be administered according to the clarity of the surgical field. | Procedure or surgery | Controlled hypotension |
Primary outcome
Surgical field clarity in relation to the value of arterial pressure
Time frame: 13 months
Clarity of the surgical field will be assessed on a scale of 0-5, according to the Boezaart's system (1995)
14 secondary outcomes
Blood pressure
Time frame: 13 months
Heart rate
Time frame: 13 months
Depth of anaesthesia
Time frame: 13 months
Near infrared spectroscopy (NIRS)
Time frame: 13 months
Consumption of hypotensives
Time frame: 13 months
Blood loss
Time frame: 13 months
Recovery from anaesthesia duration
Time frame: 13 months
Postoperative pain
Time frame: 13 months
Cognitive function
Time frame: 13 months
Postoperative nausea
Time frame: 13 months
Postoperative vomiting
Time frame: 13 months
Complications of controlled hypotension
Time frame: 13 months
Use of tamponade
Time frame: 13 months
Surgical revision
Time frame: 13 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Background: PubMed 23844295Thongrong C, Kasemsiri P, Carrau RL, Bergese SD. Control of bleeding in endoscopic skull base surgery: current concepts to improve hemostasis. ISRN Surg. 2013 Jun 13;2013:191543. doi: 10.1155/2013/191543. Print 2013.
- Background: PubMed 23258603Kelly EA, Gollapudy S, Riess ML, Woehlck HJ, Loehrl TA, Poetker DM. Quality of surgical field during endoscopic sinus surgery: a systematic literature review of the effect of total intravenous compared to inhalational anesthesia. Int Forum Allergy Rhinol. 2013 Jun;3(6):474-81. doi: 10.1002/alr.21125. Epub 2012 Dec 19.
- Background: PubMed 17989575Athanasiadis T, Beule A, Embate J, Steinmeier E, Field J, Wormald PJ. Standardized video-endoscopy and surgical field grading scale for endoscopic sinus surgery: a multi-centre study. Laryngoscope. 2008 Feb;118(2):314-9. doi: 10.1097/MLG.0b013e318157f764.
- Background: PubMed 23263204Milonski J, Zielinska-Blizniewska H, Golusinski W, Urbaniak J, Sobanski R, Olszewski J. Effects of three different types of anaesthesia on perioperative bleeding control in functional endoscopic sinus surgery. Eur Arch Otorhinolaryngol. 2013 Jul;270(7):2045-50. doi: 10.1007/s00405-012-2311-1. Epub 2012 Dec 22.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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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.
Ondřej Jor, MD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Chronic Rhinosinusitis (Diagnosis), run by University Hospital Ostrava at 1 site in Czechia.
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 7 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 31 Mar 2023. 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 Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Surgical field clarity in relation to the value of arterial pressure (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03815435, which also lists 4 linked publications.
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 31 Mar 2023.