NCT04105946

Brief Summary

Opioid Free Anesthesia (OFA) - which has been applied mainly in bariatric surgery - has begun to receive more and more attention and to obtain fanatical supporters versus conventional anesthesia. The advantages of this type of anesthesia are mainly achieved by the action and effect of the various drugs that compose it. Functional Endoscopic Sinus Surgery is performed in cases where sinusitis or its complications are difficult to treat with medication. With special cameras and endoscopes, the narrow anatomical regions of the sinus can be depicted and precisely surgically approached. Usually surgery is conducted under general anesthesia. According to the literature, total intravenous anesthesia should be used for sinus surgery to achieve blood pressure control as well as controlled hypotension to prevent intraoperative bleeding. Most of the studies agree that the best type of anesthesia for this type of surgery is total intravenous anesthesia. When it comes to Opioid Free Anesthesia in FESS, there are not many studies, except of some studies that don't use solely Opioid Free Anesthesia but some of the drugs that consist it. Patients scheduled for elective Functional Endoscopic Sinus Surgery will be randomised in two groups. One receiving OFA and one receiving TIVA.

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
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

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

First Submitted

Initial submission to the registry

September 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
3 years until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 19, 2022

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

September 24, 2019

Last Update Submit

August 17, 2022

Conditions

Functional Endoscopic Sinus Surgery

Keywords

FESSOpioid Free AnesthesiaOpioid Consumption

Outcome Measures

Primary Outcomes (2)

  • Pain management

    Visual Analogue Scale score for pain after FESS

    48 hours

  • Intraoperative bleeding in the surgical field

    Surgeon bleeding scale 0-3 for bleeding in the operative field

    intraoperatively

Secondary Outcomes (1)

  • Patient Satisfaction

    48 hours

Study Arms (2)

OFA Group

ACTIVE COMPARATOR

patients undergoing FESS under opiod free anesthesia

Drug: Dexmedetomidine

TIVA Group

ACTIVE COMPARATOR

patients undergoing FESS under total intravenous anesthesia

Drug: Remifentanil

Interventions

DexmedetomidineDRUG

dexmedetomidine administration intraoperatively in combination with other drugs used in OFA

OFA Group
RemifentanilDRUG

remifentanil administration intraoperatively in combination with other drugs used in TIVA

TIVA Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 - 75 years old
  • Elective FESS

You may not qualify if:

  • Patients \< 18 or \>75 years of age
  • Patients who can't read of speak the Greek language
  • Patients with psychiatric disorders
  • Patients with atrioventricular block in ECG
  • Patients with musculoskeletal disorders
  • Patients with coronary artery disease
  • Patients uncapable of giving informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Thessaly

Larissa, Thessaly, 41110, Greece

Location

MeSH Terms

Interventions

DexmedetomidineRemifentanil

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidines

Study Officials

  • Elena Arnaoutoglou, MD, PhD

    University of Thessaly

    STUDY CHAIR

  • Ioannis Chatzioannou, MD, PhD

    University of Thessaly

    STUDY DIRECTOR

  • Dimitra Papaspirou, MD

    University Hospital of Larissa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Metaxia Bareka, MD, PhD

CONTACT

+306947845083barekametaxia@hotmail.com

Dimitra Papaspirou, MD

CONTACT

+306982004382dimitra.papaspyrou@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

September 24, 2019

First Posted

September 26, 2019

Study Start

October 1, 2022

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

August 19, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)