The Influence of Blood Pressure Upon the Clarity of Surgical Field in Endonasal Surgery

Chronic Rhinosinusitis (Diagnosis) Clinical Trial

Official title:

The Influence of Blood Pressure Upon the Clarity of Surgical Field in Endonasal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03815435
• Other study ID #: KARIM-01-ENSURGERY
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: March 2023
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Rhinosinusitis (Diagnosis)
• Sinusitis

Intervention

Procedure:
• Controlled hypotension
Controlled hypotension will be administered according to the clarity of the surgical field.

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	13 months
Secondary	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.	13 months
Secondary	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.	13 months
Secondary	Depth of anaesthesia	Depth of anaesthesia will be measured using the BIS value every 5 minutes	13 months
Secondary	Near infrared spectroscopy (NIRS)	Cerebral perfusion will be measured using the NIRS value every 5 minutes	13 months
Secondary	Consumption of hypotensives	Consumption of hypotensives (Nitro Pohl) will be measured in mg/hr	13 months
Secondary	Blood loss	Blood loss (ml) during the surgery will be measured	13 months
Secondary	Recovery from anaesthesia duration	The interval from the end of surgery to eye opening in minutes will be measured.	13 months
Secondary	Postoperative pain	Postoperative pain will be measured using the VAS (Visual Analogue Scale) upon arrival to the recovery room and the standard ward.	13 months
Secondary	Cognitive function	The standardised clock-drawing test will be performed at the ward, 2 hours after surgery.	13 months
Secondary	Postoperative nausea	The presence of postoperative nausea (YES/NO) will be observed.	13 months
Secondary	Postoperative vomiting	The presence of postoperative vomiting (YES/NO) will be observed.	13 months
Secondary	Complications of controlled hypotension	The presence of complications of controlled hypotension (stroke, myocardial infarction, kidney injury - YES/NO) will be observed.	13 months
Secondary	Use of tamponade	The need to use tamponade due to bleeding (YES/NO) will be observed.	13 months
Secondary	Surgical revision	The need for surgical revision due to bleeding (YES/NO) will be observed.	13 months