Tear Film AlterationNCT07326332
Effect of Dexmedetomidine on Tear Production in Angioplasty Patients
A study testing Dexmedetomidine and Sedation with Midazolam, Fentanyl, and Propofol in people with Tear Film Alteration, run by Benha University at 1 site in Egypt.
Trial summary
During medical procedures performed under local anesthesia with sedation, such as angioplasty, the eyes may become dry because normal blinking and tear production can be reduced. Dexmedetomidine is a commonly used sedative that provides comfort and pain relief while allowing patients to breathe on their own. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tear Film Alteration
- What is being tested?
- Dexmedetomidine and Sedation with Midazolam, Fentanyl, and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 20 Jun 2026
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for elective angioplasty (coronary PCI or peripheral angioplasty) under local anesthesia with planned procedural sedation.
- Able to give informed consent and complete ocular symptom assessments.
- Baseline Schirmer I ≥1 mm (to exclude complete anatomic lacrimal failure; you may alter this cutoff).
Who cannot join
- Pre-existing moderate/severe dry eye disease or Sjögren's syndrome (history or OSDI >33).
- Ocular surgery within prior 3 months or active ocular infection.
- Contact lens use within 24 hours before baseline.
- Chronic systemic medications known to substantially alter lacrimation (recent anticholinergics, high-dose tricyclics) unless stable and documented.
- Known allergy to dexmedetomidine, midazolam, fentanyl, or propofol.
- Significant bradycardia (HR <50) or high-degree AV block without pacemaker.
- Pregnancy or breastfeeding.
- Any condition making study participation or follow-up impossible.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Benha University Hospital
Banhā, Qalyubia Governorate, 13511
Samar Amin, +201287793991, samar.rafik@gmail.com
About this study
Official title: Effect of Dexmedetomidine Sedation on Tear Film in Patients Undergoing Angioplasty Under Local Anesthesia
During medical procedures performed under local anesthesia with sedation, such as angioplasty, the eyes may become dry because normal blinking and tear production can be reduced. Dexmedetomidine is a commonly used sedative that provides comfort and pain relief while allowing patients to breathe on their own. However, there is limited information about how dexmedetomidine affects tear production and eye comfort after procedures.
This study aims to evaluate whether sedation with dexmedetomidine affects tear production compared with standard sedative medications used during angioplasty. Adult patients undergoing angioplasty under local anesthesia will be randomly assigned to receive either dexmedetomidine sedation or standard sedation. Tear production will be measured using the Schirmer test before the procedure, shortly after the procedure, and 12 hours later. Patients will also be asked about eye dryness or discomfort, and any eye-related or sedation-related side effects will be recorded.
The results of this study may help improve eye safety and comfort in patients receiving sedation during angioplasty and guide the selection of sedative medications in clinical practice.
- Conditions
- Tear Film Alteration
- Being tested
- Dexmedetomidine, Sedation with Midazolam, Fentanyl, and Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine will be administered intravenously for procedural sedation during angioplasty under local anesthesia. A loading dose of 0.4-0.6 µg/kg may be given over 10 minutes at the discretion of the anesthesiologist, followed by a continuous infusion of 0.2-0.7 µg/kg/hour titrated to achieve moderate sedation (RASS -2 to 0). Rescue sedation with small propofol boluses may be used if required and will be documented.
Sedation with Midazolam, Fentanyl, and PropofolDrug
Standard sedation will be provided according to routine clinical practice during angioplasty under local anesthesia. Sedation may include intermittent intravenous boluses of midazolam, with or without opioid analgesics (e.g., fentanyl), and/or small propofol boluses, titrated to achieve moderate sedation (RASS -2 to 0). All administered drugs and cumulative doses will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Sedation | Experimental | Participants in this arm will be sedated with intravenous dexmedetomidine during angioplasty performed under local anesthesia. Dexmedetomidine will be administered as a loading dose (if clinically appropriate) followed by a continuous infusion titrated to achieve moderate sedation (RASS -2 to 0). Rescue sedation with small propofol boluses may be used if needed and will be recorded. Receives: Drug: Dexmedetomidine |
| Standard Sedation | Active comparator | Participants in this arm will receive standard sedation according to routine clinical practice during angioplasty under local anesthesia. Sedation may include intermittent intravenous boluses of midazolam with or without opioid analgesics (e.g., fentanyl) and/or small propofol boluses, titrated to achieve moderate sedation (RASS -2 to 0). Receives: Drug: Sedation with Midazolam, Fentanyl, and Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tear Production Measured by Schirmer I Test
Change in tear production measured by the Schirmer I test (without topical anesthesia), calculated as the difference in millimeters (mm) between baseline (pre-procedure, awake) and immediate post-procedure measurement once the patient is responsive (Aldrete score ≥9). Measurements will be performed in a standardized manner by a trained, blinded assessor.
Measured: Baseline (30 minutes pre-procedure) to 30 minutes post-procedure
Secondary outcomes (4)
Immediate Post-Procedure Tear Production (Schirmer I Test)
Tear production measured using the Schirmer I test (mm) immediately after the procedure, once the patient is responsive (Aldrete score ≥9), and compared between study groups.
Measured: 30-60 minutes after completion of the procedure
Patient-Reported Dry Eye Symptoms
Dry eye symptoms assessed using a visual analog scale (VAS) ranging from 0 to 10, where 0 = no dry eye symptoms and 10 = worst imaginable dry eye symptoms.
Measured: Baseline (pre-procedure), immediate post-procedure, and 12 hours post-procedure
Incidence of Ocular Adverse Events
Occurrence of ocular adverse events, including corneal abrasion, corneal epithelial defects, conjunctival hyperemia, blurred vision, or severe dry eye requiring ophthalmologic consultation.
Measured: From start of procedure to 12 hours post-procedure
Total Dexmedetomidine Dose
Total cumulative dose of dexmedetomidine administered during the procedure, expressed in micrograms (µg).
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tear Film AlterationStudies of the same condition, open and under way.
- More trials run by Benha 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Rafik Mohamed Amin, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326332
- Sponsor's protocol ID
- RC.18.10.2025
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine Sedation on Tear Film in Patients Undergoing Angioplasty Under Local Anesthesia
- ClinicalTrials.gov ID
- NCT07326332
- Acronym / sponsor ID
- RC.18.10.2025
- Conditions
- Tear Film Alteration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 8 Jan 2026 (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.
During medical procedures performed under local anesthesia with sedation, such as angioplasty, the eyes may become dry because normal blinking and tear production can be reduced. Dexmedetomidine is a commonly used sedative that provides comfort and pain relief while allowing patients to breathe on their own. However, there is limited information about how dexmedetomidine affects tear production and eye comfort after procedures.
This study aims to evaluate whether sedation with dexmedetomidine affects tear production compared with standard sedative medications used during angioplasty. Adult patients undergoing angioplasty under local anesthesia will be randomly assigned to receive either dexmedetomidine sedation or standard sedation. Tear production will be measured using the Schirmer test before the procedure, shortly after the procedure, and 12 hours later. Patients will also be asked about eye dryness or discomfort, and any eye-related or sedation-related side effects will be recorded.
The results of this study may help improve eye safety and comfort in patients receiving sedation during angioplasty and guide the selection of sedative medications in clinical practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Sedation | Experimental | Drug: DexmedetomidineParticipants in this arm will be sedated with intravenous dexmedetomidine during angioplasty performed under local anesthesia. Dexmedetomidine will be administered as a loading dose (if clinically appropriate) followed by a continuous infusion titrated to achieve moderate sedation (RASS -2 to 0). Rescue sedation with small propofol boluses may be used if needed and will be recorded. |
| Standard Sedation | Active comparator | Drug: Sedation with Midazolam, Fentanyl, and PropofolParticipants in this arm will receive standard sedation according to routine clinical practice during angioplasty under local anesthesia. Sedation may include intermittent intravenous boluses of midazolam with or without opioid analgesics (e.g., fentanyl) and/or small propofol boluses, titrated to achieve moderate sedation (RASS -2 to 0). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled for elective angioplasty (coronary PCI or peripheral angioplasty) under local anesthesia with planned procedural sedation.
- Able to give informed consent and complete ocular symptom assessments.
- Baseline Schirmer I ≥1 mm (to exclude complete anatomic lacrimal failure; you may alter this cutoff).
Key exclusion criteria (8 listed)
- Pre-existing moderate/severe dry eye disease or Sjögren's syndrome (history or OSDI >33).
- Ocular surgery within prior 3 months or active ocular infection.
- Contact lens use within 24 hours before baseline.
- Chronic systemic medications known to substantially alter lacrimation (recent anticholinergics, high-dose tricyclics) unless stable and documented.
- Known allergy to dexmedetomidine, midazolam, fentanyl, or propofol.
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 |
|---|---|---|
| DexmedetomidineDexmedetomidine will be administered intravenously for procedural sedation during angioplasty under local anesthesia. A loading dose of 0.4-0.6 µg/kg may be given over 10 minutes at the discretion of the anesthesiologist, followed by a continuous infusion of 0.2-0.7 µg/kg/hour titrated to achieve moderate sedation (RASS -2 to 0). Rescue sedation with small propofol boluses may be used if required and will be documented. | Drug | Dexmedetomidine Sedation |
| Sedation with Midazolam, Fentanyl, and PropofolStandard sedation will be provided according to routine clinical practice during angioplasty under local anesthesia. Sedation may include intermittent intravenous boluses of midazolam, with or without opioid analgesics (e.g., fentanyl), and/or small propofol boluses, titrated to achieve moderate sedation (RASS -2 to 0). All administered drugs and cumulative doses will be recorded. | Drug | Standard Sedation |
Primary outcome
Change in Tear Production Measured by Schirmer I Test
Time frame: Baseline (30 minutes pre-procedure) to 30 minutes post-procedure
Change in tear production measured by the Schirmer I test (without topical anesthesia), calculated as the difference in millimeters (mm) between baseline (pre-procedure, awake) and immediate post-procedure measurement once the patient is responsive (Aldrete score ≥9). Measurements will be performed in a standardized manner by a trained, blinded assessor.
4 secondary outcomes
Immediate Post-Procedure Tear Production (Schirmer I Test)
Time frame: 30-60 minutes after completion of the procedure
Patient-Reported Dry Eye Symptoms
Time frame: Baseline (pre-procedure), immediate post-procedure, and 12 hours post-procedure
Incidence of Ocular Adverse Events
Time frame: From start of procedure to 12 hours post-procedure
Total Dexmedetomidine Dose
Time frame: During the procedure
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 8 Jan 2026.
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 study testing Dexmedetomidine and Sedation with Midazolam, Fentanyl, and Propofol in people with Tear Film Alteration, run by Benha 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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 8 Jan 2026. 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?
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 Samar R Amin, M.D. (+201287793991, samar.rafik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tear Production Measured by Schirmer I Test (time frame: Baseline (30 minutes pre-procedure) to 30 minutes post-procedure). 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 8 Jan 2026.