Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2020-03-01
2021-03-31
Brief Summary
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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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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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propofol
Propofol
TCI 4 µg/mL start until BIS-value of 50
sevoflurane
Sevoflurane
start 1 MAC, until BIS-value of 50
Interventions
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Propofol
TCI 4 µg/mL start until BIS-value of 50
Sevoflurane
start 1 MAC, until BIS-value of 50
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* patients which have coagulation disorders
* patients with high bleeding risk
* patients with arterial hypertension
* other decided by surgeon
18 Years
ALL
Yes
Sponsors
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Algemeen Ziekenhuis Maria Middelares
OTHER
Responsible Party
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Dr. Alain Kalmar, MD, PhD
Staff Anesthesist
Principal Investigators
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Alain F Kalmar, MD, PhD, MSc
Role: PRINCIPAL_INVESTIGATOR
Maria Middelares Hospital
Locations
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General Hospital Maria Middelares
Ghent, Oost-Vlaanderen, Belgium
Countries
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Central Contacts
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Facility Contacts
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Alain F Kalmar, MD, PhD
Role: primary
Other Identifiers
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MMS.2019.043
Identifier Type: -
Identifier Source: org_study_id