Drug UseNCT05361642
Regional Nasal Block and Dexmedetomidine in Endoscopic Sinus Surgery
A study testing Bupivacaine HCl 0.5% Injectable Solution and Dexmedetomidine in people with Drug Use, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose is to compare the efficacy of combined regional nasal block and general anesthesia versus general anesthesia with dexmedetomidine during endoscopic sinus surgery in optimizing intraoperative surgical field. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Use
- What is being tested?
- Bupivacaine HCl 0.5% Injectable Solution and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Feb 2022to 5 Dec 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of ASA I or ASA II physical status.
- Patients with age 18-65 years.
Who cannot join
- Patients with physical status ASA III, IV.
- Known allergic reactions to local anesthetics.
- Patients with history for cerebrovascular or coronary insufficiency.
- Patients with infection at the block site.
- Patients with coagulopathy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Moustafa Rakha
Cairo, 0200
Moustafa Rakha, 01061123460, moustafaatef.13b@gmail.com
About this study
Official title: Comparison Between Combined Regional Nasal Block and General Anesthesia Versus General Anesthesia With Dexmedetomidine During Endoscopic Sinus Surgery
The purpose is to compare the efficacy of combined regional nasal block and general anesthesia versus general anesthesia with dexmedetomidine during endoscopic sinus surgery in optimizing intraoperative surgical field.
Read the detailed description
This study will be done to compare between two different techniques including regional nasal block and dexmedetomidine in optimizing intraoperative surgical field according to average category scale
- Conditions
- Drug Use
- Being tested
- Bupivacaine HCl 0.5% Injectable Solution, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine HCl 0.5% Injectable SolutionDrug
Also called Lidocaine 2%
using nasal block including sphenopalatine ganglion block with general anesthesia to optimize surgical field
DexmedetomidineDrug
using dexmedetomidine with induction of general anesthesia to optimize surgical field
| Study group | Role | What they receive |
|---|---|---|
| regional nasal block | Active comparator | sphenopalatine ganglion block with general anesthesia Receives: Drug: Bupivacaine HCl 0.5% Injectable Solution |
| dexmedetomidine | Active comparator | use the drug with general anesthesia Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimizing intraoperative surgical field
Comparison between efficacy of the two techniques in optimizing intraoperative surgical field which will be measured using the average category scale(where grade 0 is defined as no bleeding and grade 5 is defined as severe bleeding, constant suctioning required).
Measured: Up to 6 months
Secondary outcomes (8)
Heart rate in beat per minute
The heart rate will be measured in (beat/minute) at the commencement of surgery and at each assessment of the surgical field. The average mean values during the surgical procedures will be calculated in each group.
Measured: Up to 8 months
Blood loss in millilitres
Blood loss will be measured in millilitres as that collected in the suction apparatus and by weight of the nasal swabs.
Measured: Up to 8 months
endtidal sevoflurane concentration in MAC%
Endtidal sevoflurane concentration will be used as an indicator of inhaled anaesthetic dose. Mean end-tidal sevoflurane concentration will be calculated for each patient as the average of all concentrations recorded will be measured in MAC%
Measured: Up to 8 months
phentolamine requirements in milligrams
The total dose of additional hypotensive agent (phentolamine) requirements will be measured in milligrams
Measured: Up to 8 months
Duration of anesthesia in minutes
Duration of anesthesia will be measured in minutes
Measured: Up to 8 months
Pain assessment with visual analogue scale(VAS)
Pain intensity will be measured with a 10-cm visual analogue scale (where 0 is defined as no pain at all and 10 as the worst possible pain) at 2, 6 and 12 hours postoperatively.
Measured: Up to 8 months
Mean blood pressure in mmHg
The mean blood pressure will be measured in mmHg at the commencement of surgery and at each assessment of the surgical field. The average mean values during the surgical procedures will be calculated in each group.
Measured: Up to 8 months
Duration of surgery in minutes
Duration of surgery will be measured in minutes
Measured: Up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start3 Feb 2022
- Primary completion5 Nov 2022 (estimated)
- Study completion5 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug UseStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nahed Effat Yossef Salama, Professor, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361642
- Sponsor's protocol ID
- FMASU MD 60/2021
- Status last verified
- Aug 2022
- First submitted
- 5 Feb 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: comparison between the two techniques in optimizing surgical field
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Combined Regional Nasal Block and General Anesthesia Versus General Anesthesia With Dexmedetomidine During Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT05361642
- Acronym / sponsor ID
- FMASU MD 60/2021
- Conditions
- Drug Use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 5 Nov 2022 (estimated)
- Study completion
- 5 Dec 2022 (estimated)
- First posted
- 5 May 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 purpose is to compare the efficacy of combined regional nasal block and general anesthesia versus general anesthesia with dexmedetomidine during endoscopic sinus surgery in optimizing intraoperative surgical field.
Detailed description
This study will be done to compare between two different techniques including regional nasal block and dexmedetomidine in optimizing intraoperative surgical field according to average category scale
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| regional nasal block | Active comparator | Drug: Bupivacaine HCl 0.5% Injectable Solutionsphenopalatine ganglion block with general anesthesia |
| dexmedetomidine | Active comparator | Drug: Dexmedetomidineuse the drug with general anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of ASA I or ASA II physical status.
- Patients with age 18-65 years.
Key exclusion criteria (5 listed)
- Patients with physical status ASA III, IV.
- Known allergic reactions to local anesthetics.
- Patients with history for cerebrovascular or coronary insufficiency.
- Patients with infection at the block site.
- Patients with coagulopathy.
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 |
|---|---|---|
| Bupivacaine HCl 0.5% Injectable SolutionAlso: Lidocaine 2%using nasal block including sphenopalatine ganglion block with general anesthesia to optimize surgical field | Drug | regional nasal block |
| Dexmedetomidineusing dexmedetomidine with induction of general anesthesia to optimize surgical field | Drug | dexmedetomidine |
Primary outcome
Optimizing intraoperative surgical field
Time frame: Up to 6 months
Comparison between efficacy of the two techniques in optimizing intraoperative surgical field which will be measured using the average category scale(where grade 0 is defined as no bleeding and grade 5 is defined as severe bleeding, constant suctioning required).
8 secondary outcomes
Heart rate in beat per minute
Time frame: Up to 8 months
Blood loss in millilitres
Time frame: Up to 8 months
endtidal sevoflurane concentration in MAC%
Time frame: Up to 8 months
phentolamine requirements in milligrams
Time frame: Up to 8 months
Duration of anesthesia in minutes
Time frame: Up to 8 months
Pain assessment with visual analogue scale(VAS)
Time frame: Up to 8 months
Mean blood pressure in mmHg
Time frame: Up to 8 months
Duration of surgery in minutes
Time frame: Up to 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Individual participant dataSharing planned: Yes. comparison between the two techniques in optimizing surgical field
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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.
Nahed Effat Yossef Salama, Professor study chair
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine HCl 0.5% Injectable Solution and Dexmedetomidine in people with Drug Use, run by Ain Shams 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 5 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 2 Sep 2022. 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 Moustafa At Moustafa Hamouda, Ass lecturer (+201061123460, moustafaatef.13b@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimizing intraoperative surgical field (time frame: Up to 6 months). 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 2 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.