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Propofol Versus Sevoflurane During FESS

Primary Purpose

Sinus Infection Chronic

Status
Unknown status
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Propofol
Sevoflurane
Sponsored by
Algemeen Ziekenhuis Maria Middelares
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sinus Infection Chronic focused on measuring haemodynamic, peripheral blood flow, FESS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • General Hospital Maria MiddelaresRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

propofol

sevoflurane

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Surgery duration
Length of surgery in minutes
Arterial blood pressure
Mean Arterial Blood Pressure (in mmHg)
Length of stay on the PACU
number of minutes on the PACU
Postoperative pain scores
Postoperative Visual Analogue scores
PONV scores
Postoperative nausea/vomiting scores

Full Information

First Posted
October 28, 2020
Last Updated
November 2, 2020
Sponsor
Algemeen Ziekenhuis Maria Middelares
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1. Study Identification

Unique Protocol Identification Number
NCT04619160
Brief Title
Propofol Versus Sevoflurane During FESS
Official Title
Influence of Propofol Versus Sevoflurane on Surgical Conditions During Functional Endoscopic Sinus Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Algemeen Ziekenhuis Maria Middelares

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinus Infection Chronic
Keywords
haemodynamic, peripheral blood flow, FESS

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
The surgeon and participant are blinded for randomization. The anesthesiologist is unblinded.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
propofol
Arm Type
Active Comparator
Arm Title
sevoflurane
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
TCI 4 µg/mL start until BIS-value of 50
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
start 1 MAC, until BIS-value of 50
Primary Outcome Measure Information:
Title
Boezaart surgical grading scale
Description
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
Secondary Outcome Measure Information:
Title
Surgery duration
Description
Length of surgery in minutes
Time Frame
Immediately after surgery
Title
Arterial blood pressure
Description
Mean Arterial Blood Pressure (in mmHg)
Time Frame
During surgery
Title
Length of stay on the PACU
Description
number of minutes on the PACU
Time Frame
From arrival on the PACU until achievement of the PACU discharge criteria
Title
Postoperative pain scores
Description
Postoperative Visual Analogue scores
Time Frame
in the first 48 hours after surgery
Title
PONV scores
Description
Postoperative nausea/vomiting scores
Time Frame
In the first 48 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alain F Kalmar, MD, PhD, MSc
Phone
+32 246 17 29
Email
alainkalmar@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nicky Van Der Vekens, DVM, PhD
Phone
+32 246 1709
Email
nicky.vandervekens@azmmsj.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain F Kalmar, MD, PhD, MSc
Organizational Affiliation
Maria Middelares Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital Maria Middelares
City
Ghent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain F Kalmar, MD, PhD
Phone
+32 9 246 1729
Email
alainkalmar@gmail.com

12. IPD Sharing Statement

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Propofol Versus Sevoflurane During FESS

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