Functional Endoscopic Sinus SurgeryNCT04105946
Opioid Free Anesthesia in ENT Surgery
A study testing Dexmedetomidine and Remifentanil in people with Functional Endoscopic Sinus Surgery, run by University of Thessaly at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Functional Endoscopic Sinus Surgery
- What is being tested?
- Dexmedetomidine and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 - 75 years old
- Elective FESS
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
Univeristy of Thessaly
Larissa, Thessaly, 41110
Eleni Arnaoutoglou, MD, PhD, 2413501370, earnaout@gmail.com
Dimitra Papaspirou, +306982004382, dimitra.papaspyrou@hotmail.com
About this study
Official title: Opioid Free Anesthesia Versus Conventional Total Intravenous Anesthesia for ENT Surgery
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.
- Conditions
- Functional Endoscopic Sinus Surgery
- Being tested
- Dexmedetomidine, Remifentanil
- Keywords
- FESS, Opioid Free Anesthesia, Opioid Consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
dexmedetomidine administration intraoperatively in combination with other drugs used in OFA
RemifentanilDrug
remifentanil administration intraoperatively in combination with other drugs used in TIVA
| Study group | Role | What they receive |
|---|---|---|
| OFA Group | Active comparator | patients undergoing FESS under opiod free anesthesia Receives: Drug: Dexmedetomidine |
| TIVA Group | Active comparator | patients undergoing FESS under total intravenous anesthesia Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain management
Visual Analogue Scale score for pain after FESS
Measured: 48 hours
Intraoperative bleeding in the surgical field
Surgeon bleeding scale 0-3 for bleeding in the operative field
Measured: intraoperatively
Secondary outcomes (1)
Patient Satisfaction
Quality of recovery questionnaire for patient satisfaction
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study startOct 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Endoscopic Sinus SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Arnaoutoglou, University of Thessaly
- Investigators
- Elena Arnaoutoglou, MD, PhD, Study chair, University of ThessalyIoannis Chatzioannou, MD, PhD, Study director, University of ThessalyDimitra Papaspirou, MD, Principal investigator, University Hospital of Larissa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105946
- Sponsor's protocol ID
- OFA in ENT
- Status last verified
- Aug 2022
- First submitted
- 24 Sep 2019
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Free Anesthesia Versus Conventional Total Intravenous Anesthesia for ENT Surgery
- ClinicalTrials.gov ID
- NCT04105946
- Acronym / sponsor ID
- OFA in ENT
- Conditions
- Functional Endoscopic Sinus Surgery
- Keywords
- FESS, Opioid Free Anesthesia, Opioid Consumption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OFA Group | Active comparator | Drug: Dexmedetomidinepatients undergoing FESS under opiod free anesthesia |
| TIVA Group | Active comparator | Drug: Remifentanilpatients undergoing FESS under total intravenous anesthesia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 - 75 years old
- Elective FESS
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidinedexmedetomidine administration intraoperatively in combination with other drugs used in OFA | Drug | OFA Group |
| Remifentanilremifentanil administration intraoperatively in combination with other drugs used in TIVA | Drug | TIVA Group |
Primary outcome
Pain management
Time frame: 48 hours
Visual Analogue Scale score for pain after FESS
Intraoperative bleeding in the surgical field
Time frame: intraoperatively
Surgeon bleeding scale 0-3 for bleeding in the operative field
1 secondary outcome
Patient Satisfaction
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Arnaoutoglou, MD, PhD study chair
University of Thessaly
Ioannis Chatzioannou, MD, PhD study director
University of Thessaly
Dimitra Papaspirou, MD principal investigator
University Hospital of Larissa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Remifentanil in people with Functional Endoscopic Sinus Surgery, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Metaxia Bareka, MD, PhD (+306947845083, barekametaxia@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain management (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022; AzTrials last refreshed its copy on 31 Oct 2026.