Propofol Versus Sevoflurane During FESS

Sinus Infection Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04619160
• Other study ID #: MMS.2019.043
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2020
• Est. completion date: March 2021

Study information

• Verified date: November 2020
• Source: Algemeen Ziekenhuis Maria Middelares
• Contact: Alain F Kalmar, MD, PhD, MSc
• Phone: +32 246 17 29
• Email: alainkalmar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sinus Infection Chronic
• Sinusitis

Intervention

Drug:
• Propofol
TCI 4 µg/mL start until BIS-value of 50
• Sevoflurane
start 1 MAC, until BIS-value of 50

Locations

Country	Name	City	State
Belgium	General Hospital Maria Middelares	Ghent	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
Algemeen Ziekenhuis Maria Middelares

Country where clinical trial is conducted

Belgium, 

Outcome

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