The Influence of Blood Pressure Upon the Clarity of Surgical Field in Endonasal Surgery
Primary Purpose
Chronic Rhinosinusitis (Diagnosis)
Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Controlled hypotension
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Rhinosinusitis (Diagnosis) focused on measuring Surgical field clarity, Endonasal surgery, Intraoperative bleeding
Eligibility Criteria
Inclusion Criteria:
- Patients with chronic rhinosinusitis undergoing pansinusoperation
- Age over 18 years
- Concrete surgeon (Petr Matoušek, MD, Ph.D., MBA)
- Concrete anaesthetist (Michal Parma, MD)
Exclusion Criteria:
- Coagulopathy
- Thrombocytopathies
- Vascular wall disorders
- Thrombophlebitis
- Anticoagulation or anti-aggregation therapy
- History of malignancy
- Pregnancy
Sites / Locations
- University Hospital Ostrava
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Controlled hypotension
Arm Description
Controlled hypotension will be administered according to the clarity of the surgical field evaluated according to the Boezaart scale (1995).
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
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.
Depth of anaesthesia
Depth of anaesthesia will be measured using the BIS value every 5 minutes
Near infrared spectroscopy (NIRS)
Cerebral perfusion will be measured using the NIRS value every 5 minutes
Consumption of hypotensives
Consumption of hypotensives (Nitro Pohl) will be measured in mg/hr
Blood loss
Blood loss (ml) during the surgery will be measured
Recovery from anaesthesia duration
The interval from the end of surgery to eye opening in minutes will be measured.
Postoperative pain
Postoperative pain will be measured using the VAS (Visual Analogue Scale) upon arrival to the recovery room and the standard ward.
Cognitive function
The standardised clock-drawing test will be performed at the ward, 2 hours after surgery.
Postoperative nausea
The presence of postoperative nausea (YES/NO) will be observed.
Postoperative vomiting
The presence of postoperative vomiting (YES/NO) will be observed.
Complications of controlled hypotension
The presence of complications of controlled hypotension (stroke, myocardial infarction, kidney injury - YES/NO) will be observed.
Use of tamponade
The need to use tamponade due to bleeding (YES/NO) will be observed.
Surgical revision
The need for surgical revision due to bleeding (YES/NO) will be observed.
Full Information
NCT ID
NCT03815435
First Posted
January 21, 2019
Last Updated
March 29, 2023
Sponsor
University Hospital Ostrava
1. Study Identification
Unique Protocol Identification Number
NCT03815435
Brief Title
The Influence of Blood Pressure Upon the Clarity of Surgical Field in Endonasal Surgery
Official Title
The Influence of Blood Pressure Upon the Clarity of Surgical Field in Endonasal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis (Diagnosis)
Keywords
Surgical field clarity, Endonasal surgery, Intraoperative bleeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study subjects will be enrolled into one arm.
Masking
None (Open Label)
Masking Description
The physician performing the surgery and assessing the surgical field clarity will be masked as to the value of the blood pressure in the individual patient.
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Controlled hypotension
Arm Type
Experimental
Arm Description
Controlled hypotension will be administered according to the clarity of the surgical field evaluated according to the Boezaart scale (1995).
Intervention Type
Procedure
Intervention Name(s)
Controlled hypotension
Intervention Description
Controlled hypotension will be administered according to the clarity of the surgical field.
Primary Outcome Measure Information:
Title
Surgical field clarity in relation to the value of arterial pressure
Description
Clarity of the surgical field will be assessed on a scale of 0-5, according to the Boezaart's system (1995)
Time Frame
13 months
Secondary Outcome Measure Information:
Title
Blood pressure
Description
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.
Time Frame
13 months
Title
Heart rate
Description
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.
Time Frame
13 months
Title
Depth of anaesthesia
Description
Depth of anaesthesia will be measured using the BIS value every 5 minutes
Time Frame
13 months
Title
Near infrared spectroscopy (NIRS)
Description
Cerebral perfusion will be measured using the NIRS value every 5 minutes
Time Frame
13 months
Title
Consumption of hypotensives
Description
Consumption of hypotensives (Nitro Pohl) will be measured in mg/hr
Time Frame
13 months
Title
Blood loss
Description
Blood loss (ml) during the surgery will be measured
Time Frame
13 months
Title
Recovery from anaesthesia duration
Description
The interval from the end of surgery to eye opening in minutes will be measured.
Time Frame
13 months
Title
Postoperative pain
Description
Postoperative pain will be measured using the VAS (Visual Analogue Scale) upon arrival to the recovery room and the standard ward.
Time Frame
13 months
Title
Cognitive function
Description
The standardised clock-drawing test will be performed at the ward, 2 hours after surgery.
Time Frame
13 months
Title
Postoperative nausea
Description
The presence of postoperative nausea (YES/NO) will be observed.
Time Frame
13 months
Title
Postoperative vomiting
Description
The presence of postoperative vomiting (YES/NO) will be observed.
Time Frame
13 months
Title
Complications of controlled hypotension
Description
The presence of complications of controlled hypotension (stroke, myocardial infarction, kidney injury - YES/NO) will be observed.
Time Frame
13 months
Title
Use of tamponade
Description
The need to use tamponade due to bleeding (YES/NO) will be observed.
Time Frame
13 months
Title
Surgical revision
Description
The need for surgical revision due to bleeding (YES/NO) will be observed.
Time Frame
13 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with chronic rhinosinusitis undergoing pansinusoperation
Age over 18 years
Concrete surgeon (Petr Matoušek, MD, Ph.D., MBA)
Concrete anaesthetist (Michal Parma, MD)
Exclusion Criteria:
Coagulopathy
Thrombocytopathies
Vascular wall disorders
Thrombophlebitis
Anticoagulation or anti-aggregation therapy
History of malignancy
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ondřej Jor, MD
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70852
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers.
Citations:
PubMed Identifier
23844295
Citation
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.
Results Reference
background
PubMed Identifier
23258603
Citation
Kelly 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.
Results Reference
background
PubMed Identifier
17989575
Citation
Athanasiadis 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.
Results Reference
background
PubMed Identifier
23263204
Citation
Milonski 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.
Results Reference
background
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The Influence of Blood Pressure Upon the Clarity of Surgical Field in Endonasal Surgery
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