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

March 29, 2023 updated by: University Hospital Ostrava
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 70852
        • University Hospital Ostrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Controlled hypotension
Controlled hypotension will be administered according to the clarity of the surgical field evaluated according to the Boezaart scale (1995).
Procedure: Controlled hypotension
Controlled hypotension will be administered according to the clarity of the surgical field.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
13 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
13 months
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.
13 months
Depth of anaesthesia
Time Frame: 13 months
Depth of anaesthesia will be measured using the BIS value every 5 minutes
13 months
Consumption of hypotensives
Time Frame: 13 months
Consumption of hypotensives (Nitro Pohl) will be measured in mg/hr
13 months
Blood loss
Time Frame: 13 months
Blood loss (ml) during the surgery will be measured
13 months
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.
13 months
Cognitive function
Time Frame: 13 months
The standardised clock-drawing test will be performed at the ward, 2 hours after surgery.
13 months
Postoperative nausea
Time Frame: 13 months
The presence of postoperative nausea (YES/NO) will be observed.
13 months
Postoperative vomiting
Time Frame: 13 months
The presence of postoperative vomiting (YES/NO) will be observed.
13 months
Use of tamponade
Time Frame: 13 months
The need to use tamponade due to bleeding (YES/NO) will be observed.
13 months
Near infrared spectroscopy (NIRS)
Time Frame: 13 months
Cerebral perfusion will be measured using the NIRS value every 5 minutes
13 months
Recovery from anaesthesia duration
Time Frame: 13 months
The interval from the end of surgery to eye opening in minutes will be measured.
13 months
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 months
Surgical revision
Time Frame: 13 months
The need for surgical revision due to bleeding (YES/NO) will be observed.
13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Investigators

  • Principal Investigator: Ondřej Jor, MD, University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

January 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

January 21, 2019

First Submitted That Met QC Criteria

January 21, 2019

First Posted (Actual)

January 24, 2019

Study Record Updates

Last Update Posted (Actual)

March 31, 2023

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KARIM-01-ENSURGERY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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