Patients Undergoing External Dacrocystorhinostomy OperationsPhase 1DCRNCT06808295
Dexmedetomidine an Effective Drug in Reducing Anesthetic Requirements in External Dacrocystorhinostomy (DCR) Patients
A Phase 1 study testing Dexmedetomidine Hydrochloride in people with Patients Undergoing External Dacrocystorhinostomy Operations and Assess Decreased Anesthetic Requirements Intraoperative, run by Research Institute of Ophthalmology, Egypt at 1 site in Egypt.
Trial summary
Assessing the intra and postoperative hemodynamic stability in patients undergoing external dacrocystorhinostomy under general anesthesia using Dexmedetomidine as a preoperative sedation compared to traditional technique with intraoperative analgesia and assessing decreased anesthetic requirements intra and… Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Patients Undergoing External Dacrocystorhinostomy Operations, Assess Decreased Anesthetic Requirements Intraoperative
- What is being tested?
- Dexmedetomidine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Apr 2024to May 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients of both sexes 16 years to 75 years of age ASA (American society of Anesthesiologists) I-III
Who cannot join
- Pediatric age group
- ASA more than III
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Dexmedetomidine As an Effective Drug in Reducing Anesthetic Requirements in Patients Undergoing External Dacrocystorhinostomy, a Randomized Controlled Study
Assessing the intra and postoperative hemodynamic stability in patients undergoing external dacrocystorhinostomy under general anesthesia using Dexmedetomidine as a preoperative sedation compared to traditional technique with intraoperative analgesia and assessing decreased anesthetic requirements intra and postoperative
Read the detailed description
Dexmedetomidine is a highly selective alpha 2 adrenoceptor agonist, having characteristics of natural sleep like sedation, can reduce pain intensity and opioid consumption without influencing the time of recovery from general anesthesia
- Conditions
- Patients Undergoing External Dacrocystorhinostomy Operations, Assess Decreased Anesthetic Requirements Intraoperative
- Being tested
- Dexmedetomidine Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine HydrochlorideDrug
drug will be given before induction and anesthetic doses and hemodynamics will be assessed pre- intra and postoperative
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | Dexmedetomidine 0.25 microgram per kilogram is used in Dacrocystorhinostomy patients 20 minutes before induction of general anesthesia Receives: Drug: Dexmedetomidine Hydrochloride |
| Control | No intervention | Fentanyl as an analgesic is used with general anesthesia in Dacrocystorhinostomy patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintained hemodynamic values while reducing the anesthetic requirements
Measuring the heart rate and the blod pressure every 5 minutes intraoperative and for half an hour postoperative to assess hemodynamic stability
Measured: from 20 minutes after administering the drug till 2 hours after full recovery
Secondary outcomes (1)
Delerium
Reducing postoperative delirium in elderly patients
Measured: from 20 minutes after administering the drug till 2 hours after full recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start16 Apr 2024
- Primary completion20 Apr 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing External Dacrocystorhinostomy OperationsStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 Groups, Dexmedetomidine group and control group are assigned
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Institute of Ophthalmology, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Moustafa Mohamed, Research Institute of Ophthalmology, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808295
- Sponsor's protocol ID
- 24-11-17-6-5
- Acronym
- DCR
- Status last verified
- Jan 2025
- First submitted
- 14 Dec 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine As an Effective Drug in Reducing Anesthetic Requirements in Patients Undergoing External Dacrocystorhinostomy, a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06808295
- Acronym / sponsor ID
- DCR / 24-11-17-6-5
- Conditions
- Patients Undergoing External Dacrocystorhinostomy Operations, Assess Decreased Anesthetic Requirements Intraoperative
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Research Institute of Ophthalmology, EgyptUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 20 Apr 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 5 Feb 2025 (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.
Assessing the intra and postoperative hemodynamic stability in patients undergoing external dacrocystorhinostomy under general anesthesia using Dexmedetomidine as a preoperative sedation compared to traditional technique with intraoperative analgesia and assessing decreased anesthetic requirements intra and postoperative
Detailed description
Dexmedetomidine is a highly selective alpha 2 adrenoceptor agonist, having characteristics of natural sleep like sedation, can reduce pain intensity and opioid consumption without influencing the time of recovery from general anesthesia
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 Groups, Dexmedetomidine group and control group are assigned
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidine HydrochlorideDexmedetomidine 0.25 microgram per kilogram is used in Dacrocystorhinostomy patients 20 minutes before induction of general anesthesia |
| Control | No intervention | –Fentanyl as an analgesic is used with general anesthesia in Dacrocystorhinostomy patients |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients of both sexes 16 years to 75 years of age ASA (American society of Anesthesiologists) I-III
Key exclusion criteria (2 listed)
- Pediatric age group
- ASA more than III
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 |
|---|---|---|
| Dexmedetomidine Hydrochloridedrug will be given before induction and anesthetic doses and hemodynamics will be assessed pre- intra and postoperative | Drug | Dexmedetomidine |
Primary outcome
Maintained hemodynamic values while reducing the anesthetic requirements
Time frame: from 20 minutes after administering the drug till 2 hours after full recovery
Measuring the heart rate and the blod pressure every 5 minutes intraoperative and for half an hour postoperative to assess hemodynamic stability
1 secondary outcome
Delerium
Time frame: from 20 minutes after administering the drug till 2 hours after full recovery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexmedetomidine Hydrochloride in people with Patients Undergoing External Dacrocystorhinostomy Operations and Assess Decreased Anesthetic Requirements Intraoperative, run by Research Institute of Ophthalmology, Egypt 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 5 Feb 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dina Moustafa Mohamed Ali, MD (01113981021, dina.moustafa.ali@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintained hemodynamic values while reducing the anesthetic requirements (time frame: from 20 minutes after administering the drug till 2 hours after full recovery). 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 5 Feb 2025.