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Opioid Free Anesthesia in ENT Surgery

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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

Tracking Information
First Submitted Date  ICMJE September 24, 2019
First Posted Date  ICMJE September 26, 2019
Last Update Posted Date October 8, 2019
Estimated Study Start Date  ICMJE October 2019
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2019)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2019)
  • Pain management [ Time Frame: 48 hours ]
    VAS score after FESS
  • Intraoperative bleeding in the surgical field [ Time Frame: intraoperatively ]
    Surgeon bleeding scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2019)
Patient Satisfaction [ Time Frame: 48 hours ]
Quality of recovery questionnaire for patient satisfaction
Original Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2019)
Patient Satisfaction [ Time Frame: 48 hours ]
Quality of recovery questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Opioid Free Anesthesia in ENT Surgery
Official Title  ICMJE Opioid Free Anesthesia Versus Conventional Total Intravenous Anesthesia for ENT Surgery
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Functional Endoscopic Sinus Surgery
Intervention  ICMJE
  • Drug: Dexmedetomidine
    dexmedetomidine administration intraoperatively in combination with other drugs used in OFA
  • Drug: Remifentanil
    remifentanil administration intraoperatively in combination with other drugs used in TIVA
Study Arms  ICMJE
  • Active Comparator: OFA Group
    patients undergoing FESS under opiod free anesthesia
    Intervention: Drug: Dexmedetomidine
  • Active Comparator: TIVA Group
    patients undergoing FESS under total intravenous anesthesia
    Intervention: Drug: Remifentanil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 24, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Metaxia Bareka, MD, PhD +306947845083 barekametaxia@hotmail.com
Contact: Dimitra Papaspirou, MD +306982004382 dimitra.papaspyrou@hotmail.com
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04105946
Other Study ID Numbers  ICMJE OFA in ENT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Elena Arnaoutoglou, University of Thessaly
Study Sponsor  ICMJE University of Thessaly
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University of Thessaly
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP