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Opioid Free Anesthesia in ENT Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04105946
Recruitment Status : Not yet recruiting
First Posted : September 26, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Elena Arnaoutoglou, University of Thessaly

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.


Condition or disease Intervention/treatment Phase
Functional Endoscopic Sinus Surgery Drug: Dexmedetomidine Drug: Remifentanil Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Opioid Free Anesthesia Versus Conventional Total Intravenous Anesthesia for ENT Surgery
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: OFA Group
patients undergoing FESS under opiod free anesthesia
Drug: Dexmedetomidine
dexmedetomidine administration intraoperatively in combination with other drugs used in OFA

Active Comparator: TIVA Group
patients undergoing FESS under total intravenous anesthesia
Drug: Remifentanil
remifentanil administration intraoperatively in combination with other drugs used in TIVA




Primary Outcome Measures :
  1. Pain management [ Time Frame: 48 hours ]
    Visual Analogue Scale score for pain after FESS

  2. Intraoperative bleeding in the surgical field [ Time Frame: intraoperatively ]
    Surgeon bleeding scale 0-3 for bleeding in the operative field


Secondary Outcome Measures :
  1. Patient Satisfaction [ Time Frame: 48 hours ]
    Quality of recovery questionnaire for patient satisfaction



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 18 - 75 years old
  • Elective FESS

Exclusion Criteria:

  1. Patients < 18 or >75 years of age
  2. Patients who can't read of speak the Greek language
  3. Patients with psychiatric disorders
  4. Patients with atrioventricular block in ECG
  5. Patients with musculoskeletal disorders
  6. Patients with coronary artery disease
  7. Patients uncapable of giving informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04105946


Contacts
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Contact: Metaxia Bareka, MD, PhD +306947845083 barekametaxia@hotmail.com
Contact: Dimitra Papaspirou, MD +306982004382 dimitra.papaspyrou@hotmail.com

Locations
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Greece
Univeristy of Thessaly
Larissa, Thessaly, Greece, 41110
Contact: Eleni Arnaoutoglou, MD, PhD    2413501370    earnaout@gmail.com   
Contact: Dimitra Papaspirou    +306982004382    dimitra.papaspyrou@hotmail.com   
Sub-Investigator: Metaxia Bareka, MD, PhD         
Principal Investigator: Eleni Arnaoutoglou, MD, PhD         
Sub-Investigator: Jiannis Hajiioannou, MD, PhD         
Sub-Investigator: Athanasios Chalkias, MD, PhD         
Sponsors and Collaborators
University of Thessaly
Investigators
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Study Chair: Elena Arnaoutoglou, MD, PhD University of Thessaly
Study Director: Ioannis Chatzioannou, MD, PhD University of Thessaly
Principal Investigator: Dimitra Papaspirou, MD University Hospital of Larissa
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Responsible Party: Elena Arnaoutoglou, Professor of Anesthesiology, University of Thessaly
ClinicalTrials.gov Identifier: NCT04105946    
Other Study ID Numbers: OFA in ENT
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elena Arnaoutoglou, University of Thessaly:
FESS
Opioid Free Anesthesia
Opioid Consumption
Additional relevant MeSH terms:
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Dexmedetomidine
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics