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

Not Applicable

Completed

• Conditions: Chronic Rhinosinusitis (Diagnosis)
• Interventions: Procedure: Controlled hypotension

• Registration Number: NCT03815435
• Lead Sponsor: University Hospital Ostrava

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.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-01-21
• Study First Submitted QC: 2019-01-21
• Study First Posted: 2019-01-24
• Primary Completion: 2020-01-31
• Study Completion: 2020-03-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Controlled hypotension	Controlled hypotension	Controlled hypotension will be administered according to the clarity of the surgical field evaluated according to the Boezaart scale (1995).

Primary Outcome Measures

Name	Time	Method
Surgical field clarity in relation to the value of arterial pressure	13 months	Clarity of the surgical field will be assessed on a scale of 0-5, according to the Boezaart's system (1995)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava, Moravian-Silesian Region, Czechia