NCT04619160

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

October 28, 2020

Last Update Submit

November 2, 2020

Conditions

Sinus Infection Chronic

Keywords

haemodynamicperipheral blood flowFESS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Surgery duration

    Immediately after surgery

  • Arterial blood pressure

    During surgery

  • Length of stay on the PACU

    From arrival on the PACU until achievement of the PACU discharge criteria

  • Postoperative pain scores

    in the first 48 hours after surgery

  • PONV scores

    In the first 48 hours after surgery

Study Arms (2)

propofol

ACTIVE COMPARATOR
Drug: Propofol

sevoflurane

ACTIVE COMPARATOR
Drug: Sevoflurane

Interventions

PropofolDRUG

TCI 4 µg/mL start until BIS-value of 50

propofol
SevofluraneDRUG

start 1 MAC, until BIS-value of 50

sevoflurane

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient planned for FESS surgery

You may not qualify if:

  • patients which receive anticoagulants
  • patients which have coagulation disorders
  • patients with high bleeding risk
  • patients with arterial hypertension
  • other decided by surgeon

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital Maria Middelares

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

MeSH Terms

Interventions

PropofolSevoflurane

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Alain F Kalmar, MD, PhD, MSc

    Maria Middelares Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alain F Kalmar, MD, PhD, MSc

CONTACT

+32 246 17 29alainkalmar@gmail.com

Nicky Van Der Vekens, DVM, PhD

CONTACT

+32 246 1709nicky.vandervekens@azmmsj.be

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
The surgeon and participant are blinded for randomization. The anesthesiologist is unblinded.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Anesthesist

Study Record Dates

First Submitted

October 28, 2020

First Posted

November 6, 2020

Study Start

March 1, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

November 6, 2020

Record last verified: 2020-11

Locations

BE(1)