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NCT Number: NCT03815435

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

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.

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Key information

Conditions

Chronic Rhinosinusitis (Diagnosis) Blood Loss, Surgical Disease Hemorrhage Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Controlled hypotension

Procedure

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Blood pressure

    Time frame: 13 months

    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.

  2. Heart rate

    Time frame: 13 months

    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.

  3. Depth of anaesthesia

    Time frame: 13 months

    Depth of anaesthesia will be measured using the BIS value every 5 minutes

  4. Near infrared spectroscopy (NIRS)

    Time frame: 13 months

    Cerebral perfusion will be measured using the NIRS value every 5 minutes

  5. Consumption of hypotensives

    Time frame: 13 months

    Consumption of hypotensives (Nitro Pohl) will be measured in mg/hr

  6. Blood loss

    Time frame: 13 months

    Blood loss (ml) during the surgery will be measured

  7. Recovery from anaesthesia duration

    Time frame: 13 months

    The interval from the end of surgery to eye opening in minutes will be measured.

  8. Postoperative pain

    Time frame: 13 months

    Postoperative pain will be measured using the VAS (Visual Analogue Scale) upon arrival to the recovery room and the standard ward.

  9. Cognitive function

    Time frame: 13 months

    The standardised clock-drawing test will be performed at the ward, 2 hours after surgery.

  10. Postoperative nausea

    Time frame: 13 months

    The presence of postoperative nausea (YES/NO) will be observed.

  11. Postoperative vomiting

    Time frame: 13 months

    The presence of postoperative vomiting (YES/NO) will be observed.

  12. Complications of controlled hypotension

    Time frame: 13 months

    The presence of complications of controlled hypotension (stroke, myocardial infarction, kidney injury - YES/NO) will be observed.

  13. Use of tamponade

    Time frame: 13 months

    The need to use tamponade due to bleeding (YES/NO) will be observed.

  14. Surgical revision

    Time frame: 13 months

    The need for surgical revision due to bleeding (YES/NO) will be observed.

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 24, 2019
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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