Clinical trial NCT03815435: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Rhinosinusitis (Diagnosis)
Keywords: Surgical field clarity
Endonasal surgery
Intraoperative bleeding
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study subjects will be enrolled into one arm.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Surgical field clarity in relation to the value of arterial pressure
timeFrame: 13 months
Secondary outcomes:
measure: Blood pressure
timeFrame: 13 months
measure: Heart rate
timeFrame: 13 months
measure: Depth of anaesthesia
timeFrame: 13 months
measure: Near infrared spectroscopy (NIRS)
timeFrame: 13 months
measure: Consumption of hypotensives
timeFrame: 13 months
measure: Blood loss
timeFrame: 13 months
measure: Recovery from anaesthesia duration
timeFrame: 13 months
measure: Postoperative pain
timeFrame: 13 months
measure: Cognitive function
timeFrame: 13 months
measure: Postoperative nausea
timeFrame: 13 months
measure: Postoperative vomiting
timeFrame: 13 months
measure: Complications of controlled hypotension
timeFrame: 13 months
measure: Use of tamponade
timeFrame: 13 months
measure: Surgical revision
timeFrame: 13 months
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Ondřej Jor, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.