RhinosinusitisPhase 4NCT06866145
Dexmedetomidine Infusion in Either Total Intravenous Anesthesia or Inhalational Anesthesia to Improve Surgical Field Visibility in Endoscopic Sinus Surgery
A Phase 4 study testing functional endoscopic sinus surgery and Dexmedetomidine in people with Rhinosinusitis, run by Menoufia University at 2 sites in Egypt.
Trial summary
Dexmedetomidine Infusion in either Total Intravenous Anesthesia or Inhalational Anesthesia to Improve Surgical Field Visibility in Endoscopic Sinus Surgery Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Rhinosinusitis
- What is being tested?
- functional endoscopic sinus surgery and Dexmedetomidine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 May 2024to 1 Jul 2025
- Phase
- Phase 4
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) class I and II patients undergoing endoscopic sinus surgery in the age group from 18-50 years.
Who cannot join
- History of allergy to medications used in the study, refusal of patients to participate, hepatic or renal dysfunction, chronic pain condition, psychological and neurological disorders
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Menoufia university hospital
Menoufia, Shibin Elkom, 6121890
Menoufia university hospital
Shibin Elkom
About this study
Dexmedetomidine Infusion in either Total Intravenous Anesthesia or Inhalational Anesthesia to Improve Surgical Field Visibility in Endoscopic Sinus Surgery
Read the detailed description
the study was prospective randomized single blinded study
- Conditions
- Rhinosinusitis
- Being tested
- functional endoscopic sinus surgery, Dexmedetomidine
- Keywords
- endoscopic sinus surgery , dexmedetomidine, surgical field visibility
- Medical subject headings
- Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional endoscopic sinus surgeryProcedure or surgery
sinus surgery
DexmedetomidineDrug
precedex
| Study group | Role | What they receive |
|---|---|---|
| TIVA group | Other | patients receives total intravenous anesthesia Receives: Procedure: functional endoscopic sinus surgery; Drug: Dexmedetomidine |
| inhalational group | Other | patients receives inhalational anesthesia Receives: Procedure: functional endoscopic sinus surgery; Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical field visibility
Surgical field visibility assessed every 15 minutes based on Boezaart scale from 0 to 5 as 0 is the worst score and 5 is the best
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 May 2024
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinosinusitisStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866145
- Sponsor's protocol ID
- 3/2024 ANE T8
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Infusion in Either Total Intravenous Anesthesia or Inhalational Anesthesia to Improve Surgical Field Visibility in Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT06866145
- Acronym / sponsor ID
- 3/2024 ANE T8
- Conditions
- Rhinosinusitis
- Keywords
- endoscopic sinus surgery , dexmedetomidine, surgical field visibility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 10 Mar 2025 (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.
Dexmedetomidine Infusion in either Total Intravenous Anesthesia or Inhalational Anesthesia to Improve Surgical Field Visibility in Endoscopic Sinus Surgery
Detailed description
the study was prospective randomized single blinded study
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIVA group | Other | Procedure: functional endoscopic sinus surgery, Drug: Dexmedetomidinepatients receives total intravenous anesthesia |
| inhalational group | Other | Procedure: functional endoscopic sinus surgery, Drug: Dexmedetomidinepatients receives inhalational anesthesia |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) class I and II patients undergoing endoscopic sinus surgery in the age group from 18-50 years.
Key exclusion criteria (1 listed)
- History of allergy to medications used in the study, refusal of patients to participate, hepatic or renal dysfunction, chronic pain condition, psychological and neurological 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 |
|---|---|---|
| functional endoscopic sinus surgerysinus surgery | Procedure or surgery | TIVA group, inhalational group |
| Dexmedetomidineprecedex | Drug | TIVA group, inhalational group |
Primary outcome
Surgical field visibility
Time frame: intraoperative
Surgical field visibility assessed every 15 minutes based on Boezaart scale from 0 to 5 as 0 is the worst score and 5 is the best
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing functional endoscopic sinus surgery and Dexmedetomidine in people with Rhinosinusitis, run by Menoufia University at 2 sites in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical field visibility (time frame: intraoperative). 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 8 Sep 2025.