A Phase 4 interventional study of Propofol and Sevoflurane in Sinus Infection Chronic, sponsored by Algemeen Ziekenhuis Maria Middelares. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-06.
Sponsored by Algemeen Ziekenhuis Maria Middelares · Phase 4, Interventional, and Prevention
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.
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.
415 studies on the registry are indexed under Sinusitis; 46 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 313 interventional studies indexed under Sinusitis.
Browse Sinusitis studies →Algemeen Ziekenhuis Maria Middelares is the lead sponsor of 36 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Drug: Propofol
Drug: Sevoflurane
TCI 4 µg/mL start until BIS-value of 50
start 1 MAC, until BIS-value of 50
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.
Time frame: during surgery
Surgery duration
Length of surgery in minutes
Time frame: Immediately after surgery
Arterial blood pressure
Mean Arterial Blood Pressure (in mmHg)
Time frame: During surgery
Length of stay on the PACU
number of minutes on the PACU
Time frame: From arrival on the PACU until achievement of the PACU discharge criteria
Postoperative pain scores
Postoperative Visual Analogue scores
Time frame: in the first 48 hours after surgery
PONV scores
Postoperative nausea/vomiting scores
Time frame: In the first 48 hours after surgery
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Algemeen Ziekenhuis Maria Middelares