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Opioid Free Anesthesia in ENT Surgery

NCT04105946 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-08-19

No results posted yet for this study

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.

Conditions

  • Functional Endoscopic Sinus Surgery

Interventions

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

Sponsors & Collaborators

  • University of Thessaly

    lead OTHER

Principal Investigators

  • Elena Arnaoutoglou, MD, PhD · University of Thessaly

  • Ioannis Chatzioannou, MD, PhD · University of Thessaly

  • Dimitra Papaspirou, MD · University Hospital of Larissa

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2023-10-31
Completion
2023-12-31

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04105946 on ClinicalTrials.gov