Sinus Infection Chronic
Conditions
Keywords
haemodynamic, peripheral blood flow, FESS
Brief summary
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
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.
Interventions
DRUGPropofol
TCI 4 µg/mL start until BIS-value of 50
DRUGSevoflurane
start 1 MAC, until BIS-value of 50
Sponsors
Algemeen Ziekenhuis Maria Middelares
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
The surgeon and participant are blinded for randomization. The anesthesiologist is unblinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Boezaart surgical grading scale | during surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgery duration | Immediately after surgery | Length of surgery in minutes |
| Arterial blood pressure | During surgery | Mean Arterial Blood Pressure (in mmHg) |
| Length of stay on the PACU | From arrival on the PACU until achievement of the PACU discharge criteria | number of minutes on the PACU |
| Postoperative pain scores | in the first 48 hours after surgery | Postoperative Visual Analogue scores |
| PONV scores | In the first 48 hours after surgery | Postoperative nausea/vomiting scores |
Countries
Belgium
Contacts
Primary ContactAlain F Kalmar, MD, PhD, MSc
Backup ContactNicky Van Der Vekens, DVM, PhD
Outcome results
None listed