Functional Endoscopic Sinus SurgeryPhase 4NCT05604599
Intranasal Versus Intravenous Dexmedetomidine for Hypotensive Anesthesia in FESS
A Phase 4 study testing Intranasal dexmedetomidine and Intravenous dexmedetomidine in people with Functional Endoscopic Sinus Surgery and Premedication, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Intranasal dexmedetomidine provided good pharmacokinetic profile. However, intravenous dexmedetomidine have been used in functional endoscopic sinus surgery for several outcomes, there is lack in studies that had compared the efficacy of intravenous and Intranasal Dexmedetomidine for improving quality of the operative… Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Functional Endoscopic Sinus Surgery, Premedication, Analgesia
- What is being tested?
- Intranasal dexmedetomidine and Intravenous dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2022to 5 Mar 2023
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 21 years of age.
- Both genders.
- American Society of Anesthesiologists (ASA) physical status classification I - III who underwent functional endoscopic sinus surgery.
Who cannot join
- Patients with a body mass index > 30 kg/m2
- Existing or recent significant disease.
- Contraindications to the use of dexmedetomidine.
- History or presence of a significant disease.
- Significant cardiovascular disease risk factors.
- Significant coronary artery disease.
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- Any known genetic predisposition.
- History of any kind of drug allergy.
- Drug abuse.
- Psychological or other emotional problems.
- Special diet or lifestyle.
- Clinically significant abnormal findings in physical examination, electrocardiographic (ECG) or laboratory screening.
- Known systemic disease requiring the use of anticoagulants.
- Any nasal disorders that may hinder nasal administration of the drugs as repeated nasal bleeding or nasal tumors.
- Patients with a history of previous functional endoscopic sinus surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intranasal Premedication With Dexmedetomidine Versus Intravenous Dexmedetomidine for Hypotensive Anesthesia During Functional Endoscopic Sinus Surgery in Adults: A Randomized Triple-Blind Trial
Intranasal dexmedetomidine provided good pharmacokinetic profile. However, intravenous dexmedetomidine have been used in functional endoscopic sinus surgery for several outcomes, there is lack in studies that had compared the efficacy of intravenous and Intranasal Dexmedetomidine for improving quality of the operative field in functional endoscopic sinus surgery.
Therefore, we established this randomized study to compare intranasal dexmedetomidine with intravenous dexmedetomidine improving quality of the operative field in functional endoscopic sinus surgery.
- Being tested
- Intranasal dexmedetomidine, Intravenous dexmedetomidine
- Keywords
- Dexmedetomidine, Intranasal, Intravenous
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal dexmedetomidineDrug
Also called Propofol 2 mg/kg, fentanyl 1 µg/kg, Cis-atracurium 0.15mg / kg, Isoflurane 1-1.5% in 50% oxygen
45 -60 min before the operation, patients will receive dose of dexmedetomidine 1microgram/kg diluted in 10ml 0.9% saline administered to each naris as drops + infusion saline
Intravenous dexmedetomidineDrug
Also called Propofol 2 mg/kg,, fentanyl 1 µg/kg , Cis-atracurium 0.15mg / kg and Isoflurane 1-1.5% in 50% oxygen
patients will receive loading dose of dexmedetomidine 1 µg/kg diluted in 10ml 0.9% saline infused over 45- 60 min before induction of anesthesia, followed by continuous infusion of (0.4 µ g/kg/h) + intranasal saline.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal dexmedetomidine group | Active comparator | 30 patients will receive 1µg/kg dexmedetomidine diluted in 10ml 0.9% saline intranasally preoperative administered to each naris as drops 45 -60 min before the operation +infusion saline. Receives: Drug: Intranasal dexmedetomidine |
| Intravenous dexmedetomidine group | Active comparator | 30 patients will receive a dose of dexmedetomidine 1 µg/kg diluted in 10ml 0.9% saline infused over 45- 60 min before induction of anesthesia + intranasal saline. Receives: Drug: Intravenous dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improving quality of the operative field.
Quality of intraoperative surgical field during functional endoscopic sinus surgery will be evaluated by the surgeons by rating the amount of bleeding according to a 6-point scale by Formmer's scores of surgical field quality (0= no bleeding; 1= bleeding, so mild it was not even a surgical nuisance; 2= moderate bleeding, a nuisance but without interference; 3= moderate bleeding that moderately compromised surgical; 4= bleeding, heavy but controllable, that significantly interfered; 5= massive uncontrollable bleeding.
Measured: during surgery (intraoperatively) 2 hours
Amount of atropine consumption
The total amount of atropine consumed will be recorded
Measured: First 24 hours postoperatively
Secondary outcomes (5)
Hemodynamics(Heart rate (bpm))
Heart rate (bpm), at base line, 5minute, 10 minute , 30 minute, 45 minute, 60 minute after patient received intranasal and after infusion of loading dose of dexmedetomidine , 5, 15, 30, 45, 60 minutes after induction of anesthesia, at end of surgery and 30 minute after recovery.
Measured: 2 hours
Hemodynamics(Mean arterial blood pressure mm Hg))
Mean arterial blood pressure mm Hg) at base line, 5minute, 10 minute , 30 minute, 45 minute, 60 minute after patient received intranasal and after infusion of loading dose of dexmedetomidine , 5, 15, 30, 45, 60 minutes after induction of anesthesia, at end of surgery and 30 minute after recovery.
Measured: 2 hours
Pain score
Pain measured with VAS: (visual analogue scale) will be assessed in post anesthesia care unit, 1, 2, 4, 6, 8, 12, 18, and 24hours postoperative.
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). patients are asked to rate their current level of pain by placing a mark on the line.
Measured: First 24 hours postoperatively
Adverse events
Adverse events will be recorded such as nausea, vomiting, hypotension and bradycardia.
Measured: 24 postoperatively
hemostatic stuffing
The degree of adverse reactions of hemostatic stuffing after functional endoscopic sinus surgery will be also evaluated (1=no swelling, can tolerate; 2= swelling, can barely tolerate; 3= swelling, cannot tolerate).
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start10 Nov 2022
- Primary completion5 Mar 2023
- Study completion5 Mar 2023
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.
- More trials run by Al-Azhar 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neveen Abd El Maksoad Kohaf, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604599
- Sponsor's protocol ID
- IRB 00012367-22-011-001
- Status last verified
- Mar 2023
- First submitted
- 28 Oct 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data can be shared with a reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Premedication With Dexmedetomidine Versus Intravenous Dexmedetomidine for Hypotensive Anesthesia During Functional Endoscopic Sinus Surgery in Adults: A Randomized Triple-Blind Trial
- ClinicalTrials.gov ID
- NCT05604599
- Acronym / sponsor ID
- IRB 00012367-22-011-001
- Keywords
- Dexmedetomidine, Intranasal, Intravenous
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 5 Mar 2023 (actual)
- Study completion
- 5 Mar 2023 (actual)
- First posted
- 3 Nov 2022 (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.
Intranasal dexmedetomidine provided good pharmacokinetic profile. However, intravenous dexmedetomidine have been used in functional endoscopic sinus surgery for several outcomes, there is lack in studies that had compared the efficacy of intravenous and Intranasal Dexmedetomidine for improving quality of the operative field in functional endoscopic sinus surgery.
Therefore, we established this randomized study to compare intranasal dexmedetomidine with intravenous dexmedetomidine improving quality of the operative field in functional endoscopic sinus surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal dexmedetomidine group | Active comparator | Drug: Intranasal dexmedetomidine30 patients will receive 1µg/kg dexmedetomidine diluted in 10ml 0.9% saline intranasally preoperative administered to each naris as drops 45 -60 min before the operation +infusion saline. |
| Intravenous dexmedetomidine group | Active comparator | Drug: Intravenous dexmedetomidine30 patients will receive a dose of dexmedetomidine 1 µg/kg diluted in 10ml 0.9% saline infused over 45- 60 min before induction of anesthesia + intranasal saline. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 21 years of age.
- Both genders.
- American Society of Anesthesiologists (ASA) physical status classification I - III who underwent functional endoscopic sinus surgery.
Key exclusion criteria (15 listed)
- Patients with a body mass index > 30 kg/m2
- Existing or recent significant disease.
- Contraindications to the use of dexmedetomidine.
- History or presence of a significant disease.
- Significant cardiovascular disease risk factors.
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 |
|---|---|---|
| Intranasal dexmedetomidineAlso: Propofol 2 mg/kg, fentanyl 1 µg/kg, Cis-atracurium 0.15mg / kg, Isoflurane 1-1.5% in 50% oxygen45 -60 min before the operation, patients will receive dose of dexmedetomidine 1microgram/kg diluted in 10ml 0.9% saline administered to each naris as drops + infusion saline | Drug | Intranasal dexmedetomidine group |
| Intravenous dexmedetomidineAlso: Propofol 2 mg/kg,, fentanyl 1 µg/kg , Cis-atracurium 0.15mg / kg and Isoflurane 1-1.5% in 50% oxygenpatients will receive loading dose of dexmedetomidine 1 µg/kg diluted in 10ml 0.9% saline infused over 45- 60 min before induction of anesthesia, followed by continuous infusion of (0.4 µ g/kg/h) + intranasal saline. | Drug | Intravenous dexmedetomidine group |
Primary outcome
Improving quality of the operative field.
Time frame: during surgery (intraoperatively) 2 hours
Quality of intraoperative surgical field during functional endoscopic sinus surgery will be evaluated by the surgeons by rating the amount of bleeding according to a 6-point scale by Formmer's scores of surgical field quality (0= no bleeding; 1= bleeding, so mild it was not even a surgical nuisance; 2= moderate bleeding, a nuisance but without interference; 3= moderate bleeding that moderately compromised surgical; 4= bleeding, heavy but controllable, that significantly interfered; 5= massive uncontrollable bleeding.
Amount of atropine consumption
Time frame: First 24 hours postoperatively
The total amount of atropine consumed will be recorded
5 secondary outcomes
Hemodynamics(Heart rate (bpm))
Time frame: 2 hours
Hemodynamics(Mean arterial blood pressure mm Hg))
Time frame: 2 hours
Pain score
Time frame: First 24 hours postoperatively
Adverse events
Time frame: 24 postoperatively
hemostatic stuffing
Time frame: 24 hours postoperatively
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 14 Mar 2023.
- Individual participant dataSharing planned: Yes. data can be shared with a reasonable request from the corresponding author
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intranasal dexmedetomidine and Intravenous dexmedetomidine in people with Functional Endoscopic Sinus Surgery and Premedication, run by Al-Azhar University at 1 site 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 3 inclusion and 15 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 14 Mar 2023. 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 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?
Improving quality of the operative field. (time frame: during surgery (intraoperatively) 2 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 14 Mar 2023.