Functional Endoscopic Sinus SurgeryNCT05595083
Intranasal vs. IV Dexmedetomidine in Endoscopic Sinus Surgery
A study testing intranasal dexmedetomidine group and intravouns dexmedetomidine group in people with Functional Endoscopic Sinus Surgery and Dexmedetomidine, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The aim of this study is to compare intranasal dexmedetomidine versus intravenous dexmedetomidine for improving the quality of the operative field in Functional endoscopic sinus surgery (FESS). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Functional Endoscopic Sinus Surgery, Dexmedetomidine
- What is being tested?
- intranasal dexmedetomidine group and intravouns dexmedetomidine group
- 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
- 1 Nov 2022to 1 Oct 2023
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years of age
- Both genders
- American Society of Anesthesiologists (ASA) physical status classification I or II
- Undergoing Functional Endoscopic Sinus Surgery.
Who cannot join
- Patients with a body mass index > 30 kg/m^2
- 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
Show all 13Show fewer
- 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
- 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
Tanta, ElGharbiaa, 31511
Mohammad F Algyar, MD, 00201111645345, mohammad.algaiar@med.kfs.edu.eg
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
The aim of this study is to compare intranasal dexmedetomidine versus intravenous dexmedetomidine for improving the quality of the operative field in Functional endoscopic sinus surgery (FESS).
Read the detailed description
Functional endoscopic sinus surgery (FESS) is a well-established therapeutic option for intractable Cytokine release syndrome (CRS) and other indications. Functional endoscopic sinus surgery (FESS) is a minimally invasive procedure and is commonly performed under controlled hypotensive anesthesia. In case of major bleeding, the risk of complications such as meningitis, blindness, intracranial injury, cerebrospinal fluid [CSF] leakage, and the duration of surgery increase . Intraoperative bleeding is the most common factor that diminishes visibility, resulting in an increased incidence of complications .
Increased bleeding sometimes causes surgeries to end before the due time. Improvement of intraoperative visibility while reducing bleeding is an important task for anesthesiologists during Functional endoscopic sinus surgery (FESS).
For this purpose, several pharmaceuticals have been used successfully to produce controlled hypotension during general anesthesia, for example inhalational anesthetics, direct vasodilators (sodium nitroprusside and nitroglycerin), beta adrenergic antagonists (propranolol and esmolol), alpha adrenergic agonists (clonidine and dexmedetomidine), calcium channel blockers, prostaglandin E1 (alprostadil) and adenosine and l-receptors agonists (remifentanil) .
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. Potentially desirable effects include decreased requirements for other anesthetics and analgesics. The most common adverse effects associated with Dexmedetomidine include hypotension, bradycardia, and even hypertension.
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 ug/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.
- Being tested
- intranasal dexmedetomidine group, intravouns dexmedetomidine group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intranasal dexmedetomidine groupDrug
patients will receive 1.5 ug/kg intranasal dexmedetomidine diluted with saline + infusion saline
intravouns dexmedetomidine groupDrug
patients will receive 0.1- 0.4 ug/kg intravenous infusion dexmedetomidine + intranasal saline.
| Study group | Role | What they receive |
|---|---|---|
| intranasal dexmedetomidine group | Experimental | patients will receive 1.5 ug/kg intranasal dexmedetomidine diluted with saline + infusion saline Receives: Drug: intranasal dexmedetomidine group |
| intravenous dexmedetomidine group | Experimental | patients will receive 0.1- 0.4 ug/kg intravenous infusion dexmedetomidine + intranasal saline. Receives: Drug: intravouns dexmedetomidine group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Formmer's scores of surgical field quality
Formmer's scores (a 6-point scale) of surgical field quality will be used to record the amount of bleeding (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: Intraoperatively
Secondary outcomes (4)
Hemodynamics effects
Heart rate will be recorded
Measured: at baseline and every 5 min till the end of procedure
Hemodynamics effects
Mean arterial blood pressure will be recorded
Measured: at baseline and every 5 min till the end of procedure
Pain level
Pain level will be evaluated using numeric rating analogue scale (NRS), which ranges from 0 to 10 points, with 0 indicating no pain, 1-3 indicating mild pain, 4-6 indicating moderate pain, and 7-10 indicating severe pain.
Measured: 24 hour postoperatively
Adverse reactions
Adverse reactions of hemostatic stuffing after Functional endoscopic sinus surgery (FESS) will be evaluated.
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 posted26 Oct 2022
- Study start1 Nov 2022
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
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 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 N/A
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595083
- Sponsor's protocol ID
- MKSU 50-9-20
- Status last verified
- Sep 2023
- First submitted
- 22 Oct 2022
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be provided under a reasonable request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 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
- NCT05595083
- Acronym / sponsor ID
- MKSU 50-9-20
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 26 Oct 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.
The aim of this study is to compare intranasal dexmedetomidine versus intravenous dexmedetomidine for improving the quality of the operative field in Functional endoscopic sinus surgery (FESS).
Detailed description
Functional endoscopic sinus surgery (FESS) is a well-established therapeutic option for intractable Cytokine release syndrome (CRS) and other indications. Functional endoscopic sinus surgery (FESS) is a minimally invasive procedure and is commonly performed under controlled hypotensive anesthesia. In case of major bleeding, the risk of complications such as meningitis, blindness, intracranial injury, cerebrospinal fluid [CSF] leakage, and the duration of surgery increase . Intraoperative bleeding is the most common factor that diminishes visibility, resulting in an increased incidence of complications .
Increased bleeding sometimes causes surgeries to end before the due time. Improvement of intraoperative visibility while reducing bleeding is an important task for anesthesiologists during Functional endoscopic sinus surgery (FESS).
For this purpose, several pharmaceuticals have been used successfully to produce controlled hypotension during general anesthesia, for example inhalational anesthetics, direct vasodilators (sodium nitroprusside and nitroglycerin), beta adrenergic antagonists (propranolol and esmolol), alpha adrenergic agonists (clonidine and dexmedetomidine), calcium channel blockers, prostaglandin E1 (alprostadil) and adenosine and l-receptors agonists (remifentanil) .
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. Potentially desirable effects include decreased requirements for other anesthetics and analgesics. The most common adverse effects associated with Dexmedetomidine include hypotension, bradycardia, and even hypertension.
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 ug/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 group | Experimental | Drug: intranasal dexmedetomidine grouppatients will receive 1.5 ug/kg intranasal dexmedetomidine diluted with saline + infusion saline |
| intravenous dexmedetomidine group | Experimental | Drug: intravouns dexmedetomidine grouppatients will receive 0.1- 0.4 ug/kg intravenous infusion dexmedetomidine + intranasal saline. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 18 years of age
- Both genders
- American Society of Anesthesiologists (ASA) physical status classification I or II
- Undergoing Functional Endoscopic Sinus Surgery.
Key exclusion criteria (13 listed)
- Patients with a body mass index > 30 kg/m^2
- 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
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 dexmedetomidine grouppatients will receive 1.5 ug/kg intranasal dexmedetomidine diluted with saline + infusion saline | Drug | intranasal dexmedetomidine group |
| intravouns dexmedetomidine grouppatients will receive 0.1- 0.4 ug/kg intravenous infusion dexmedetomidine + intranasal saline. | Drug | intravenous dexmedetomidine group |
Primary outcome
Formmer's scores of surgical field quality
Time frame: Intraoperatively
Formmer's scores (a 6-point scale) of surgical field quality will be used to record the amount of bleeding (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)
4 secondary outcomes
Hemodynamics effects
Time frame: at baseline and every 5 min till the end of procedure
Hemodynamics effects
Time frame: at baseline and every 5 min till the end of procedure
Pain level
Time frame: 24 hour postoperatively
Adverse reactions
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 6 Sep 2023.
- Individual participant dataSharing planned: Yes. The data will be provided under a reasonable request from the corresponding author.
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Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
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FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
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Effect of Vitamin C Administration on Intraoperative Bleeding in Patients Undergoing Sinusoscopy
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intranasal dexmedetomidine group and intravouns dexmedetomidine group in people with Functional Endoscopic Sinus Surgery and Dexmedetomidine, 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 4 inclusion and 13 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 6 Sep 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.
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 F. Algyar, MD (111645345 ext. +20, 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?
Formmer's scores of surgical field quality (time frame: Intraoperatively). 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 6 Sep 2023.