Nasal PackingPhase 4NCT05911776
Nasal Packing Versus Intravenous Dexmedetomidine in Turbinate Surgeries
A Phase 4 study testing Nasal packing Dexmedetomidine and Intravenous Dexmedetomidine in people with Nasal Packing and Dexmedetomidine, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Comparing of nasal packing DEX and IV DEX for controlling the intraoperative bleeding after turbinate surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasal Packing, Dexmedetomidine, Turbinate
- What is being tested?
- Nasal packing 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
- 30 Jun 2023to 27 Feb 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years
- Both sexes
- American Society of Anesthesiologists (ASA) physical status classification I or II.
- Undergo turbinate 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 or any known genetic predisposition.
- History of any kind of drug allergy,
- Drug abuse.
Show all 9Show fewer
- 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 turbinate surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nasal Packing Versus Intravenous Dexmedetomidine in Turbinate Surgeries: A Randomized Double-Blinded Trial
Comparing of nasal packing DEX and IV DEX for controlling the intraoperative bleeding after turbinate surgery.
Read the detailed description
Dexmedetomidine (DEX) is a highly selective α2 adreno-receptor agonist with higher affinity to a2 adreno-receptor than clonidine, and this makes DEX primarily sedative and anxiolytic. The elimination half-life of DEX (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.
- Conditions
- Nasal Packing, Dexmedetomidine, Turbinate
- Being tested
- Nasal packing Dexmedetomidine, Intravenous Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal packing DexmedetomidineDrug
patients will receive nasal packing Dexmedetomidine (1.5 μg/kg intranasal dexmedetomidine diluted with saline) and Intravenous infusion saline.
Intravenous DexmedetomidineDrug
patients will receive 0.5 μg/kg bolus over 10 min then 0.1- 0.4 μg/kg Intravenous infusion Dexmedetomidine and nasal packing with saline.
| Study group | Role | What they receive |
|---|---|---|
| Group NP (nasal packing Dexmedetomidine) | Active comparator | Patients will receive nasal packing Dexmedetomidine (1.5 μg/kg intranasal dexmedetomidine diluted with saline) and Intravenous infusion saline. Receives: Drug: Nasal packing Dexmedetomidine |
| Group IV (Intravenous Dexmedetomidine) | Active comparator | Patients will receive 0.5 μg/kg bolus over 10 min then 0.1- 0.4 μg/kg IV infusion Dexmedetomidine and nasal packing with saline. Receives: Drug: Intravenous Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of intraoperative blood loss
Measuring the volume of suctioned blood in graduated columns, which will contain an anticoagulant to prevent coagulation and clotting and weighing gauze sponges.
Measured: Intraoperative up to 6hours
Secondary outcomes (3)
Pain score
Visual analogue scale (VAS) (0, no discomfort and no pain; 10, a high level of discomfort and maximum pain)
Measured: 24 hours postoperative
Quality of intraoperative surgical field
Quality of intraoperative surgical field during after turbinate 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: Intraoperative up to 6hours
Patient's general satisfaction
Patients' satisfaction will be measured immediately postoperative and using a five-point Likert scale consisting of "very dissatisfied," "dissatisfied," "unsure," "satisfied," and "very satisfied.
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start30 Jun 2023
- Primary completion27 Feb 2024
- Study completion27 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal PackingStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamal Hendawy Shams, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911776
- Sponsor's protocol ID
- KFSIRB200-3
- Status last verified
- Mar 2024
- First submitted
- 18 May 2023
- Last updated
- 12 Mar 2024
- 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 corresponding author for one year after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Packing Versus Intravenous Dexmedetomidine in Turbinate Surgeries: A Randomized Double-Blinded Trial
- ClinicalTrials.gov ID
- NCT05911776
- Acronym / sponsor ID
- KFSIRB200-3
- Conditions
- Nasal Packing, Dexmedetomidine, Turbinate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 22 Jun 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.
Comparing of nasal packing DEX and IV DEX for controlling the intraoperative bleeding after turbinate surgery.
Detailed description
Dexmedetomidine (DEX) is a highly selective α2 adreno-receptor agonist with higher affinity to a2 adreno-receptor than clonidine, and this makes DEX primarily sedative and anxiolytic. The elimination half-life of DEX (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group NP (nasal packing Dexmedetomidine) | Active comparator | Drug: Nasal packing DexmedetomidinePatients will receive nasal packing Dexmedetomidine (1.5 μg/kg intranasal dexmedetomidine diluted with saline) and Intravenous infusion saline. |
| Group IV (Intravenous Dexmedetomidine) | Active comparator | Drug: Intravenous DexmedetomidinePatients will receive 0.5 μg/kg bolus over 10 min then 0.1- 0.4 μg/kg IV infusion Dexmedetomidine and nasal packing with saline. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 65 years
- Both sexes
- American Society of Anesthesiologists (ASA) physical status classification I or II.
- Undergo turbinate surgery
Key exclusion criteria (9 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 |
|---|---|---|
| Nasal packing Dexmedetomidinepatients will receive nasal packing Dexmedetomidine (1.5 μg/kg intranasal dexmedetomidine diluted with saline) and Intravenous infusion saline. | Drug | Group NP (nasal packing Dexmedetomidine) |
| Intravenous Dexmedetomidinepatients will receive 0.5 μg/kg bolus over 10 min then 0.1- 0.4 μg/kg Intravenous infusion Dexmedetomidine and nasal packing with saline. | Drug | Group IV (Intravenous Dexmedetomidine) |
Primary outcome
Amount of intraoperative blood loss
Time frame: Intraoperative up to 6hours
Measuring the volume of suctioned blood in graduated columns, which will contain an anticoagulant to prevent coagulation and clotting and weighing gauze sponges.
3 secondary outcomes
Pain score
Time frame: 24 hours postoperative
Quality of intraoperative surgical field
Time frame: Intraoperative up to 6hours
Patient's general satisfaction
Time frame: 24 hours postoperative
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 12 Mar 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the corresponding author for one year after study completion.
Related trials for Nasal Packing
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
Recruiting
Efficacy and Safety of NasoAid® After Nasal Surgery
Nasal Surgery, Hemostasis
Recruiting
Comparative Study - Transseptal Suture Technique Verses Anterior Nasal Packing After Septoplasty
Deviated Nasal Septum, Postoperative Nasal Pain
Enrolling by invitation
Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate (MF)
Chronic Rhinosinusitis (CRS), Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Not yet recruitingPhase 2/3
Improving Postoperative Analgesia After Functional Endoscopic Surgery
Pain Management After Functional Endoscopic Sinuscopy
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 Nasal packing Dexmedetomidine and Intravenous Dexmedetomidine in people with Nasal Packing 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 9 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 12 Mar 2024. 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?
Amount of intraoperative blood loss (time frame: Intraoperative up to 6hours). 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 12 Mar 2024.