DexmedetomidinePhase 4NCT06081933
Intranasal Dexmedetomidine Versus Intravenous Dexmedetomidine for Improving Quality of Endoscopic Sinus Surgery
A Phase 4 study testing intranasal dexmedetomidine and intravenous dexmedetomidine in people with Dexmedetomidine and Functional Endoscopic Sinus, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
compare intranasal dexmedetomidine versus intravenous dexmedetomidine for improving quality of the operative field in Functional endoscopic sinus surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dexmedetomidine, Functional Endoscopic Sinus
- 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
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2022to 15 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients underwent Functional Endoscopic Sinus Surgery
- American Society of Anesthesiologists (ASA) physical status classification I or II
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 or any known genetic predisposition
- history of any kind of drug allergy
- drug abuse
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- 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, patients with a history of previous Functional Endoscopic Sinus Surgery
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mohammad Fouad Algyar
Kafr ash Shaykh, Kafr El-Shaikh, 33516
Mohammad F Algyar, MD, 00201111645345 ext. 047, mohammad.algaiar@med.kfs.edu.eg
Kamal Ebeid, MD
About this study
Official title: Intranasal Dexmedetomidine Versus Intravenous Dexmedetomidine for Improving Quality of the Operative Field in Functional Endoscopic Sinus Surgery: A Randomized Triple-Blind Trial
compare intranasal dexmedetomidine versus intravenous dexmedetomidine for improving quality of the operative field in Functional endoscopic sinus surgery
Read the detailed description
Functional endoscopic sinus surgery is a well-established therapeutic option for intractable CRS and other indications. Functional endoscopic sinus surgery is a minimally invasive procedure and is commonly performed under controlled hypotensive anesthesia. In case of major bleeding, risk of complications such as meningitis, blindness, intracranial injury, cerebrospinal fluid leakage and the duration of surgery increase. Intraoperative bleeding is the most common factor that diminishes visibility, resulting in an increased incidence of complications.
Dexmedetomidine is a highly selective α2 adreno-receptor agonist with higher affinity to a2 adreno-receptor than clonidine, and this makes dexmedetomidine primarily sedative and anxiolytic.The elimination half-life of dexmedetomidine (t1/2b) is 2 h and the redistribution half-life (t1/2a) is 6 min, and this short half-life makes it an ideal drug for intravenous titration.
Intranasal Dexmedetomidine is convenient, effective, and noninvasive and also has useful analgesic and sedative effects in surgical procedures. Cheung's research has shown that intranasal Dexmedetomidine 1 and 1.5 micro/kg in surgical procedures produced significant sedation and less postoperative pain. Several previous research were determined the effect of intranasal dexmedetomidine in several clinical evaluations
- Conditions
- Dexmedetomidine, Functional Endoscopic Sinus
- Being tested
- intranasal dexmedetomidine, intravenous dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intranasal dexmedetomidineDrug
Patients will receive 1.5 micro g/kg intranasal dexmedetomidine diluted with saline + infusion saline
intravenous dexmedetomidineDrug
patients will receive 0.1- 0.4 micro g/kg intravenous infusion dexmedetomidine + intranasal saline.
| Study group | Role | What they receive |
|---|---|---|
| intranasal dexmedetomidine | Experimental | Patients will receive 1.5 micro g/kg intranasal dexmedetomidine diluted with saline + infusion saline Receives: Drug: intranasal dexmedetomidine |
| intravenous dexmedetomidine | Experimental | patients will receive 0.1- 0.4 micro g/kg intravenous infusion dexmedetomidine + 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
Patients' satisfaction will be measured immediately postoperative and after 24 hours using a five-point Likert scale consisting of "very dissatisfied," "dissatisfied," "unsure," "satisfied," and "very satisfied.
Measured: 24 hours postoperative
Secondary outcomes (4)
Heart rate will be evaluated
Heart rate will be recorded at baseline and every 5 min till the end of procedure
Measured: every 5 min till the end of procedure
Mean arterial blood pressure will be evaluated.
Mean arterial blood pressure will be recorded at baseline and every 5 min till the end of procedure
Measured: every 5 min till the end of procedure
Pain score will be evaluated.
Pain score will be evaluated measured with Numerical rating scale The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable
Measured: 24 hour postoperatively
Adverse reactions of hemostatic stuffing after FESS will be evaluated.
1=no swelling, can tolerate; 2= swelling, can barely tolerate; 3= swelling, cannot tolerate
Measured: 24 hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start20 Dec 2022
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fouad Algyar, Kafrelsheikh University
- Investigators
- Kamal Ebeid, MD, Principal investigator, Lecturer of Otorhinolaryngology, Faculty of medicine, Tanta University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081933
- Sponsor's protocol ID
- MKSU-50-9-20
- Status last verified
- Mar 2023
- First submitted
- 11 Dec 2022
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Dexmedetomidine Versus Intravenous Dexmedetomidine for Improving Quality of the Operative Field in Functional Endoscopic Sinus Surgery: A Randomized Triple-Blind Trial
- ClinicalTrials.gov ID
- NCT06081933
- Acronym / sponsor ID
- MKSU-50-9-20
- Conditions
- Dexmedetomidine, Functional Endoscopic Sinus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 13 Oct 2023 (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.
compare intranasal dexmedetomidine versus intravenous dexmedetomidine for improving quality of the operative field in Functional endoscopic sinus surgery
Detailed description
Functional endoscopic sinus surgery is a well-established therapeutic option for intractable CRS and other indications. Functional endoscopic sinus surgery is a minimally invasive procedure and is commonly performed under controlled hypotensive anesthesia. In case of major bleeding, risk of complications such as meningitis, blindness, intracranial injury, cerebrospinal fluid leakage and the duration of surgery increase. Intraoperative bleeding is the most common factor that diminishes visibility, resulting in an increased incidence of complications.
Dexmedetomidine is a highly selective α2 adreno-receptor agonist with higher affinity to a2 adreno-receptor than clonidine, and this makes dexmedetomidine primarily sedative and anxiolytic.The elimination half-life of dexmedetomidine (t1/2b) is 2 h and the redistribution half-life (t1/2a) is 6 min, and this short half-life makes it an ideal drug for intravenous titration.
Intranasal Dexmedetomidine is convenient, effective, and noninvasive and also has useful analgesic and sedative effects in surgical procedures. Cheung's research has shown that intranasal Dexmedetomidine 1 and 1.5 micro/kg in surgical procedures produced significant sedation and less postoperative pain. Several previous research were determined the effect of intranasal dexmedetomidine in several clinical evaluations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intranasal dexmedetomidine | Experimental | Drug: intranasal dexmedetomidinePatients will receive 1.5 micro g/kg intranasal dexmedetomidine diluted with saline + infusion saline |
| intravenous dexmedetomidine | Experimental | Drug: intravenous dexmedetomidinepatients will receive 0.1- 0.4 micro g/kg intravenous infusion dexmedetomidine + intranasal saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients underwent Functional Endoscopic Sinus Surgery
- American Society of Anesthesiologists (ASA) physical status classification I or II
Key exclusion criteria (10 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
- significant coronary artery disease or any known genetic predisposition
- history of any kind of drug allergy
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 dexmedetomidinePatients will receive 1.5 micro g/kg intranasal dexmedetomidine diluted with saline + infusion saline | Drug | intranasal dexmedetomidine |
| intravenous dexmedetomidinepatients will receive 0.1- 0.4 micro g/kg intravenous infusion dexmedetomidine + intranasal saline. | Drug | intravenous dexmedetomidine |
Primary outcome
Improving quality of the operative field
Time frame: 24 hours postoperative
Patients' satisfaction will be measured immediately postoperative and after 24 hours using a five-point Likert scale consisting of "very dissatisfied," "dissatisfied," "unsure," "satisfied," and "very satisfied.
4 secondary outcomes
Heart rate will be evaluated
Time frame: every 5 min till the end of procedure
Mean arterial blood pressure will be evaluated.
Time frame: every 5 min till the end of procedure
Pain score will be evaluated.
Time frame: 24 hour postoperatively
Adverse reactions of hemostatic stuffing after FESS will be evaluated.
Time frame: 24 hour postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the principal investigator
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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.
Kamal Ebeid, MD principal investigator
Lecturer of Otorhinolaryngology, Faculty of medicine, Tanta University, Egypt
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 Dexmedetomidine and Functional Endoscopic Sinus, run by Kafrelsheikh 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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 13 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad F Algyar, MD (00201111645345 ext. 047, mohammad.algaiar@med.kfs.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improving quality of the operative field (time frame: 24 hours postoperative). 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 13 Oct 2023.