Propofol Versus Sevoflurane During FESS

Study Overview
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Brief Summary
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Good surgical conditions are crucial for an optimal surgery result and safe procedure. Minimal blood loss in the surgical field is one of the most important conditions to maintain a good visualization, especially in surgeries with a small surgical field such as a FESS (functional endoscopic sinus surgery). The perioperative blood loss is determined by the main arterial and venous pressure, the local pressure and the capillary vascular filling pressure. It has been proposed that propofol is a venodilator, which increases the blood flow, but decreases the capillary pressure. On the contrary, sevoflurane might act mainly on the arterioles, which causes an increase in the capillary pressure. In a previous study it has been demonstrated that despite blood pressure maintenance, propofol causes less bleeding during spinal surgery than sevoflurane. The main aim of this study was to compare both anaesthetics on the perioperative bleeding and haemodynamics during FESS. Secondary, the postoperative nausea, vomiting, pain scores, surgery duration and length of stay at the post-anesthesia care unit will be evaluated.

Detailed Description
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2 X 30 patients which are planned for FESS surgery are randomized in a sevoflurane group or propofol group. All patients will be induced with propofol (target-controlled infusion (TCI) 4 µg/mL) and remifentanil (TCI 4 ng/mL) and receive a multimodal intravenous analgesia. Patients in the propofol group will receive further intravenous propofol until a bispectral index (BIS) value of 50 is reached. The intravenous drip of propofol will be stopped after induction in the sevoflurane group and patients will receive sevoflurane as inhalation anaesthetic (1 MAC) until a BIS-value of 50. The surgeon will be blinded for patient allocation. The surgical conditions will be graded postoperatively by the surgeon who performed the operation using the validated Boezaart grading scale. The endoscopic images will be evaluated in addition by 3 blinded surgeons using this same scale. Besides the surgical conditions, haemodynamic parameters, nausea and vomiting scores (PONV), Visual Analogue Score (VAS), surgery duration, length of stay at the post-anesthesia care unit and postoperative analgesia and anti-emetics are registered.

Official Title
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Influence of Propofol Versus Sevoflurane on Surgical Conditions During Functional Endoscopic Sinus Surgery

Conditions
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Sinus Infection Chronic

Intervention / Treatment
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* Drug: Propofol
* Drug: Sevoflurane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient planned for FESS surgery Exclusion Criteria: patients which receive anticoagulants patients which have coagulation disorders patients with high bleeding risk patients with arterial hypertension other decided by surgeon

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: propofol<br> | Drug: Propofol<br>* TCI 4 µg/mL start until BIS-value of 50<br>|
| Active Comparator: sevoflurane<br> | Drug: Sevoflurane<br>* start 1 MAC, until BIS-value of 50<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boezaart surgical grading scale | Evaluation of surgical conditions by determination of the validated Boezaart surgical grading scale. Score 0 (no bleeding) to 5 (severe bleeding) The scale will be determined by the operating surgeon and 3 independent surgeons based on an endoscopic video recording. | during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery duration | Length of surgery in minutes | Immediately after surgery | 
| Arterial blood pressure | Mean Arterial Blood Pressure (in mmHg) | During surgery | 
| Length of stay on the PACU | number of minutes on the PACU | From arrival on the PACU until achievement of the PACU discharge criteria | 
| Postoperative pain scores | Postoperative Visual Analogue scores | in the first 48 hours after surgery | 
| PONV scores | Postoperative nausea/vomiting scores | In the first 48 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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haemodynamic, peripheral blood flow, FESS